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Cervical ripening by prostaglandin E2 in patients with a previous cesarean section
G Model JOGOH 101699 No. of Pages 8
Journal of Gynecology Obstetrics and Human Reproduction xxx (2019) xxx–xxx
Available online at
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Original Article
Cervical ripening by prostaglandin E2 in patients with a previous cesarean section Hanane Bouchghoula,b,* , Suzanne Zeinoa , Marie Houlliera , Marie-Victoire Senata,b a b
Assistance Publique-Hôpitaux De Paris, Bicêtre Hospital, Department of Gynecology-Obstetrics, Le Kremlin-Bicêtre, France Université Paris-Saclay, Univ. Paris-Sud, UVSQ, CESP, INSERM, Villejuif, 94807 France
A R T I C L E I N F O
A B S T R A C T
Article history: Received 12 November 2019 Received in revised form 22 January 2020 Accepted 22 January 2020 Available online xxx
Objective: To assess the efficacy and safety of prostaglandin in inducing labor in pregnant women with one previous cesarean section. Secondly, to evaluate predictors of successful vaginal delivery in cervical ripening by prostaglandin in these women. Study design: This was an observational, retrospective, single-center study conducted in a type 3 maternity unit at Bicêtre University Hospital between January 1, 2013 and December 31, 2016. Patients with one previous cesarean section, a singleton pregnancy, a fetus in the cephalic presentation with a medical indication for induction of labor and an unfavorable cervix (Bishop score less than 6) were included in the study. Cervical ripening was performed using a dinoprostone intravaginal device for a duration of 24 h. Results: A total of 153 patients were included in the study. The rate of vaginal delivery was 55.6 % (85/153) overall and 78.3 % (36/46) in the subgroup of 46 women with a previous vaginal delivery before or after the cesarean section. There was no difference in neonatal and maternal morbidity (defined by intraoperative wounds or postpartum hemorrhage or uterine rupture) and mortality between women who delivered vaginally and women who had a cesarean section. The two cases of complete uterine rupture have been reported for patients whose labor was induced by intravaginal prostaglandin followed by intravenous oxytocin. The total maternal morbidity rate was 11.8 % (n = 8/68) in the case of emergency cesarean section. Predictors of vaginal delivery were a history of vaginal delivery, the onset of labor following cervical ripening, and a higher Bishop score before and after the 24 h following the cervical ripening. Conclusion: Cervical ripening by prostaglandin after previous cesarean delivery has a 56 % success rate, with a 1.3 % risk of uterine rupture, especially when prostaglandin is combined with oxytocin. Low-risk patients should be identified to propose cervical ripening by prostaglandin. © 2020 Elsevier Masson SAS. All rights reserved.
Keywords: Cervical ripening Labor induction Previous cesarean section Prostaglandins
1. Introduction Before the 1980s, vaginal delivery was contraindicated in the event of a previous cesarean section, and an iterative cesarean section was systematically performed according to Cragin's adage "a cesarean section one day, a cesarean section always" [1]. From the 1990s, after the publication of several studies whose results were in favor of trial of labor after a cesarean section, with vaginal delivery rates of 75 %, trial of labor was strongly encouraged [2,3].
* Corresponding author at: Department of Obstetrics and Gynecology, AP-HP, Bicêtre Hospital, 78, avenue du Général Leclerc, 94275 Le Kremlin-Bicêtre, Cedex, France. E-mail address: [email protected] (H. Bouchghoul).
Primary cesarean section rates have increased worldwide in the last 30 years [4]. Cervical ripening after cesarean section remains controversial considering the risks of uterine rupture and maternal and neonatal morbidity. But the main complications of iterative cesarean section are risks of hemorrhage, thromboembolism, infection, and of urological, gastrointestinal and vascular wounds [5]. Long-term risks are those of repeat cesarean deliveries as uterine rupture in a subsequent pregnancy, and placental insertion anomalies (placenta previa, accreta, percreta), which cause morbidity and mortality (hysterectomy, blood transfusion, perioperative wounds) [6]. So, neither repeat cesarean delivery nor trial of labor is risk-free. To date, there is no consensus regarding induction of labor, especially cervical ripening in the case of previous cesarean section. French recommendations encourage vaginal delivery after a cesarean section delivery, particularly in the case of spontaneous
http://dx.doi.org/10.1016/j.jogoh.2020.101699 2468-7847/© 2020 Elsevier Masson SAS. All rights reserved.
Please cite this article in press as: H. Bouchghoul, et al., Cervical ripening by prostaglandin E2 in patients with a previous cesarean section, J Gynecol Obstet Hum Reprod (2020), https://doi.org/10.1016/j.jogoh.2020.101699
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H. Bouchghoul et al. / J Gynecol Obstet Hum Reprod xxx (2019) 101699
labor [7]. But they specify that the greatest caution should be exercised because of the significant increase in the risk of uterine rupture. The decision to use prostaglandins as an induction method should consider obstetrical and maternal factors that may influence the success of vaginal delivery [7]. ACOG updated its recommendations by encouraging trial of labor and not contraindicating the use of prostaglandin, after having informed the patient about the increased risk of uterine rupture [8]. However, induction of labor in patients with a previous cesarean section remains highly debated, especially because of the risk of uterine rupture [9–12]. The risk of uterine rupture was increased among women whose labor was induced by prostaglandin, as compared with those who went into spontaneous labor [9,11,12]. But these results are controversial because of many biases, including retrospective studies, the lack of distinction between complete and sub-serous uterine rupture, the modalities of diagnosis of uterine rupture, the lack of information on the type of prostaglandin, the doses used and the management during labor. In other studies, the risk of uterine rupture was not increased in patients with cervical ripening by prostaglandin [13,14]. A randomized trial included 42 women who were assigned to either prostaglandin or oxytocin for the induction of labor in the case of a previous cesarean section [14]. In the prostaglandin group, the cesarean section rate was lower than in the oxytocin group, with no difference in the uterine rupture rate. However, few data are available in the literature on the use of vaginal prostaglandin in the case of previous cesarean section or on predictors of vaginal delivery in patients with a prior cesarean undergoing cervical ripening. The aim of our study was to assess the efficacy and safety of prostaglandin in inducing labor in pregnant women with one previous cesarean section. The second objective was to evaluate predictors of successful vaginal delivery in cervical ripening in these women.
2. Material and methods This was an observational, retrospective, single-center study conducted in a type 3 maternity unit at Bicêtre University Hospital between January 1, 2013 and December 31, 2016. Patients with one previous cesarean section, a singleton pregnancy, a fetus in the cephalic presentation with a medical indication for induction of labor and an unfavorable cervix (Bishop score less than 6) were included in the study. The exclusion criteria were multiple pregnancies, more than one previous caesarean section, placenta previa, or any other contraindication to vaginal delivery, termination of pregnancy or stillbirth. Cervical ripening was performed using a sustained-release dinoprostone intravaginal device. The device was placed at the posterior vaginal fornix for a duration of 24 h in the absence of complications. Fetal heart rate monitoring was performed 30 min before and 2 h after the insertion of the dinoprostone intravaginal device, then 6 h and 12 h after, or if uterine contractions, bleeding or rupture of membranes occurred. If labor started during cervical ripening, the intravaginal device was removed and the patient was admitted to the labor ward. Otherwise, after 24 h of cervical ripening, if the Bishop score was greater than or equal to 6, the labor induction was continued by intravenous oxytocin associated with amniotomy. If the Bishop score was less than 6, the decision was left to the obstetrician after discussion with the patient. The obstetrician had the choice of performing a cesarean section for cervical ripening failure or continuing the induction of labor with amniotomy, intravenous oxytocin or prostaglandin. Before the cervical ripening by the intravaginal dinoprostone device, the patient was given information on the modalities of labor induction, success rate, and the risks of uterine rupture.
Table 1 Maternal characteristics and modalities of cervical ripening by the intravaginal prostaglandin device in patients with a previous cesarean section and a Bishop score of less than 6.
Maternal age, years Pre-pregnancy BMI, kg/m2 BMI at the end of pregnancy, kg/m2 Primiparas History of vaginal delivery, n (%) Gestational age at the previous cesarean section, median Planned previous cesarean section Interval between previous cesarean section and cervical ripening, months Gestational diabetes Gestational hypertension/ preeclampsia. Fetal growth restriction Preterm rupture of membranes before 36 WG Gestational age at cervical ripening, weeks of gestation Bishop score at admission Bishop score 24 hours after cervical ripening Events during cervical ripening Fetal distress Rupture of membranes Loss of the device Bleeding Duration of cervical ripening, hours Intravenous oxytocin during labor Duration of intravenous oxytocin, hours Maximum dose of intravenous oxytocin, mIU/mL Duration of labor, hours Interval between cervical ripening and birth, hours
Total n = 153
Vaginal delivery n = 85
Cesarean section n = 68
p
32 [28–35] 26.1 [23.1–29.4] 31.6 [28.5–34.3] 107 (70.0 %) 46 (30.0 %) 40+0[38-40] 28 (18.3 %) 48 [36–72]
32 [28–35] 26.0 [23.1–29.1] 31.6 [28.4–34.0] 49 (57.6 %) 36 (42.3 %) 39+0 [37+3-40+2] 12 (17.6 %) 48 [36–84]
32 [28–35] 26.5 [23.2–29.7] 31.6 [28.7–34.5] 58 (85.3 %) 10 (14.7 %) 40+0 [38+0–40+0] 16 (18.8 %) 48 [27–72]
0.66 0.94 0.81 <0.001 <0.001 0.70 0.85 0.42
55 (36 %) 11 (7.2 %) 15 (9.8 %) 2 (1.3 %) 39+4 [38+3–41+1] 2 [1–2] 4 [2–5]
29 (34.1 %) 4 (4.7 %) 6 (7.1 %) 2 (2.3 %) 39+4 [38+1–41+0] 2 [1–3] 5 [3–6]
26 (38.2 %) 7 (10.3 %) 9 (13.2 %) 0 (0.0 %) 39+5 [38+4–41+1] 2 [1,2] 3 [2–5]
0.60 0.22 0.27 0.20 0.34 0.01 <0.001
22 (14.4 %) 11 (7.2 %) 13 (8.5 %) 4 (2.6 %) 16.0 [9.5–24.0] 96 (62.7 %) 3 [2–7] 12.5 [10.0–20.0] 4.0 [2.0–7.0] 21.0 [14.0–26.0]
8 (9.4 %) 5 (5.9 %) 9 (10.6 %) 2 (2.3 %) 13.0 [7.5–24.0] 59 (69.4 %) 4 [2–7] 15.0 [10.0–20.0] 5 .0[3.0–7.0] 18.0 [12.0–28.0]
14 (20.6 %) 6 (8.8 %) 4 (5.9 %) 2 (2.9 %) 22.5 [12.0–24.0] 37 (54.4 %) 3 [1–6] 10.0 [8.7–17.5] 2 [0–4.7] 24.0 [15.2–26.0]
0.05 0.54 0.39 1.00 0.003 0.06 0.37 0.17 <0.001 0.31
Data are expressed as the median with the interquartile range for quantitative variables and as a percentage for qualitative data.
Please cite this article in press as: H. Bouchghoul, et al., Cervical ripening by prostaglandin E2 in patients with a previous cesarean section, J Gynecol Obstet Hum Reprod (2020), https://doi.org/10.1016/j.jogoh.2020.101699
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2.1. Outcomes
3.1. Maternal and obstetrical characteristics
The primary outcome parameter was the vaginal delivery rate. Secondary outcome measures were the neonatal outcome parameters (e.g. arterial cord blood pH, and lactate, 5-minute Apgar score, postpartum admission to neonatal care unit) and maternal morbidity defined by post-partum hemorrhage, uterine rupture, or a wound complication in the case of cesarean section.
The median age of patients was 32 years [28–35] and the average BMI at the beginning of pregnancy was 27 kg/m2 (4.9) (Table 1). The median parity was 1 [1–2], with 46 (30 %) who had a previous vaginal delivery before and/or after cesarean section. The main indications for the first cesarean section were fetal distress in 40 % of cases, breech presentation in 13.1 %, failure to progress in 12.4 %, vascular diseases (preeclampsia, retroplacental hematoma, HELLP syndrome) in 11.7 % and failure to induce labor in 10.5 %. The main indications for cervical ripening were prolonged pregnancy in 29.4 % of cases (45), rupture of membranes at term in 22.2 % (34), gestational diabetes in 17.0 % (26), fetal indication (no fetal movements, oligohydramnios or fetal heart abnormalities) in 11.1 % (17), hypertensive disorders at the end of pregnancy in 8.5 % (13), maternal disease in 6.5 % (10), small for gestational age in 2.0 % (3) and others (cholestasis, bleeding, maternal hyperthermia) in 3.3 % (5).
2.2. Statistics Data for quantitative variables are expressed as mean with standard deviation or preferably as medians with interquartile interval, with the 1 st and 3rd quartiles corresponding to the 25th and 75th percentiles [Q1-Q3]. Qualitative data are expressed as percentages. Simple comparisons were made by using the χ2 (or exact Fisher) test for qualitative variables and Student's t-test for quantitative variables. A logistic regression with estimation of the odds ratio was performed to study the association between each explanatory variable and vaginal delivery. Regarding the Bishop score, which is a continuous variable, we first tested the linearity of the relationship before performing a logistic regression. We performed a multivariate analysis to consider confusion biases. Adjustment was made for the variables identified in the univariate analysis. The statistical analysis was performed using Stata 14 software (StataCorp LP, College Station, TX, USA). This study received the approval of the Institutional Review Board (CEROG: n 2020-OBS-0101). 3. Results Of 14 390 patients delivered in the maternity unit at the University Hospital of Bicêtre between January 2013 and December 2016, 1896 had one previous cesarean delivery (13.1 %) and of these 1294 (68.2 %) had a trial of labor. Of these 1294 patients, 155 (12.0 %) had a labor induction by vaginal prostaglandin E2 and two of these were excluded: one patient whose fetus had fetal ascites of undetermined origin and one patient who received an intracervical balloon after cervical ripening by a dinoprostone intrauterine device. A total of 153 patients were therefore included in the study between January 1, 2013 and December 31, 2016.
3.2. Cervical ripening Events that occurred during cervical ripening are presented in Table 1: 22 patients (14.4 %) had fetal distress, 11 (7.2 %) had rupture of membranes, 13 (8.5 %) lost the device, and 4 (2.6 %) had bleeding. The average duration of insertion of the dinoprostone intravaginal device was 16 h (7.6). The average interval between the beginning of cervical ripening and birth was 20 h and 18 min (8.5). Intravenous oxytocin was administered in 62.1 % of cases (96/153), with a mean duration of the intravenous oxytocin perfusion of 4.3 h (3.1). The maximum dose of oxytocin administered was 14.5 mIU/min ((4.3). 3.3. Mode of delivery The vaginal delivery rate was 55.6 % (85/153), including 22.4 % (19/85) of cases of instrumental vaginal delivery (Table 2). Among the 46 women with a previous vaginal delivery before or after the cesarean section, the vaginal delivery rate was 78.3 % (36/46). Fig. 1 shows the rate of vaginal delivery according to the onset of labor and, if not, according to the cervical changes during cervical ripening by dinoprostone. The vaginal delivery rate was higher for patients who entered labor than for patients who did not: 79.2 % (38/48) versus 42.9 % (47/105).
Table 2 Predictors of vaginal delivery after cervical ripening by the intravaginal dinoprostone device, for patients with one previous cesarean section.
Maternal age more than 35 years BMI more than 40 kg/m2 at the end of pregnancy History of vaginal delivery History of planned cesarean Suspicion of macrosomia (fetal weight estimation above the 95th percentile) Suspicion of fetal growth retardation (fetal weight estimation below the 10th percentile) Gestational age above 37 WG Bishop score before cervical ripening Bishop score after the 24 hours following cervical ripening Onset of labor during the 24 hours following cervical ripening
Vaginal delivery n = 85
Cesarean section n = 68
p
OR*
ORa**
25.9 % (22) 7.1 % (6) 42.3 % (36) 81.2 % (69) 1.2 % (1)
25.0 % (17) 7.3 % (5) 14.7 % (10) 82.3 % (56) 1.5 % (1)
0.90 1.00 <0.01 0.85 1.0
1.05 [0.50–2.18] 0.96 [0.28–3.28] 4.26 [1.92–9.46] 0.92 [0.40–2.11] 0.80 [0.05–13.00]
0.63 [0.27–1.49] 0.53 [0.13–2.19] 4.46 [1.90–10.46] 1.40 [0.55–3.56] 0.32 [0.02–6.53]
3.5 % (3)
8.6 % (8)
0.06
0.26 [0.07–1.08]
0.30 [0.07–1.26]
88.2 % (75) 1.91 (0.97) 4.85 (2.17)
91.2 % (62) 1.5 (097) 3.32 (215)
0.55 0.008 <0.001
0.73 [0.25–2.11] 1.59 [1.13–2.24] R* 1.41 [1.18–1.67]
2.82 [0.86–9.26] 1.63 [1.14–2.36] 1.34 [1.11–1.62]
44.7 % (38)
14.7 % (10)
<0.001
4.69 [2.12–10.39]
3.83 [1.63–9.02]
BMI: body mass index, WG: weeks of gestation. * Odds ratio with its 95 % confidence interval (95 % CI). ** Odds ratio adjusted for the Bishop score before cervical ripening, the history of a previous vaginal delivery, the body mass index at the end of the pregnancy, and the suspicion of fetal growth retardation.
Please cite this article in press as: H. Bouchghoul, et al., Cervical ripening by prostaglandin E2 in patients with a previous cesarean section, J Gynecol Obstet Hum Reprod (2020), https://doi.org/10.1016/j.jogoh.2020.101699
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Fig. 1. Flow chart and rate of vaginal delivery according to the beginning of labor and cervical changes during cervical ripening by dinoprostone.
The cesarean section rate was 44.4 % (68/153), with a rate of failure to induce labor (cesarean section cervix below 6 cm) of 36.6 % (56/153). The main indication for cesarean section was fetal distress in 52.9 % of cases (n = 36/68). The absence of cervical changes after 24 h of cervical ripening was the second main indication for cesarean section with a rate of 27.9 % (n = 19/68). The third cause of cesarean section was failure to induce labor by intravenous oxytocin, with a rate of 11.8 % (n = 8/68). Other indications were failure to progress (n = 4/68, 5.9 %) and bleeding (n = 1/68, 1.5 %). Among the 68 cesarean sections, four were performed during the 24 h following cervical ripening and before labor, three for fetal distress and one for bleeding. After 24 h of cervical ripening, 18.3 % (28/153) of women had a Bishop score below 6 and were not in labor. A cesarean section was decided for 23 of these 28 women (i.e. 82.1 %) by the obstetrician, after discussion with the patient. 3.4. Maternal morbidity Postpartum hemorrhage was the main maternal complication and was observed in 4.0 % (6/153) of women, all of whom delivered vaginally. Among these, 5 were resolved by the administration of sulprostone and one was resolved after uterine revision and administration of oxytocin. There was no severe postpartum hemorrhage. Two cases of complete uterine rupture and two of serous uterine rupture were observed. For the two cases of complete uterine rupture, after 24 h of cervical ripening by prostaglandin, oxytocin was perfused to induce labor. For the first case, after 5 h of intravenous oxytocin at a maximum dose of 12.5 mIU/min, the
cesarean section was performed for fetal distress. The complete uterine rupture with the fetal shoulder through the hysterotomy was diagnosed during cesarean section. A 3580-gram neonate was born with a 5-minute Apgar score of 10 and an arterial cord blood pH of 7.24. For the second case, after 1 h of intravenous oxytocin at a maximum dose of 5 mIU/min, the cesarean section was performed for fetal distress. The complete uterine rupture occurred with a vertical slit line and the fetus in an intraabdominal position. The 2790-gram neonate was born with a 5-minute Apgar score of 6, an arterial cord blood pH of 6.88 and lactate at 12 mmol/L. There were no maternal complications for these cases. One case of uterine rupture under the serous membrane was diagnosed during a uterine revision performed for nonplacental detachment, without hemorrhage. The second one was diagnosed during a cesarean performed for fetal distress with no maternal or fetal consequences. Five patients who had an emergency cesarean section had intraoperative wounds, with 2 bladder wounds, 2 slit lines on the uterus and 1 uterine artery wound, respectively. Indications for cesarean section were fetal distress in three cases and failure to induce labor in two. One patient required a second surgery for a wall hematoma that occurred 3 h after the procedure. So, the maternal morbidity rate was 11.8 % (n = 8/68) in the case of emergency cesarean section. 3.5. Predictors of vaginal delivery Predictors significantly associated with vaginal delivery after cervical ripening with prostaglandin E2 were a previous vaginal
Please cite this article in press as: H. Bouchghoul, et al., Cervical ripening by prostaglandin E2 in patients with a previous cesarean section, J Gynecol Obstet Hum Reprod (2020), https://doi.org/10.1016/j.jogoh.2020.101699
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3.6. Neonatal morbidity The average birth weight of newborns was 3238 g (518) (Table 3). Neonatal acidosis with an arterial cord blood pH less than 7.00 was observed in 4.1 % of newborns (6/148). The rate of respiratory distress was 6.5 % (10/153). There was no significant difference in neonatal outcomes according to the mode of delivery. However, there was a trend to more neonatal complications (arterial cord blood pH less than 7.10, 5-minute Apgar score less than 7, resuscitation in the birth room, respiratory distress, transfer to neonatal care unit) in the case of cesarean delivery. No maternal, fetal or neonatal deaths were reported. 4. Discussion In our series, the vaginal delivery rate after prostaglandin cervical ripening for women with one previous cesarean section was 55.6 %, with a uterine rupture rate of 1.3 % as expected. Among women who entered labor after cervical ripening, the vaginal delivery rate was 79.2 %, whereas it was 42.9 % for patients who did not. However, among women delivered by emergency cesarean section, the maternal morbidity rate was 11.8 %. There was no difference in neonatal and maternal morbidity and mortality between women who delivered vaginally and women who had a cesarean section. The two cases of complete uterine rupture were reported for patients whose labor was induced by intravenous oxytocin after 24 h of prostaglandin cervical ripening. 4.1. Vaginal delivery rate Fig. 2. Prediction of vaginal delivery according to. (a) the initial Bishop score. Modeling using a logistic regression, after adjustment for the history of a previous vaginal delivery, the body mass index at the end of the pregnancy, and the suspicion of fetal growth retardation. (b) the Bishop score after 24 h of cervical ripening. Modeling using a logistic regression, after adjustment for the initial Bishop score, the onset of labor following cervical ripening, the history of a previous vaginal delivery, the body mass index at the end of the pregnancy, and the suspicion of fetal growth retardation.
delivery (ORa = 4.46 [95 % CI: 1.90–10.46], p = 0.001) and onset of labor after cervical ripening (ORa = 3.83 [95 % CI: 1.63–9.02], p = 0.002) (Table 2). This relation was adjusted for the Bishop score before cervical ripening, the history of a previous vaginal delivery, the body mass index at the end of the pregnancy, and the suspicion of fetal growth retardation. Modeling showed a significant association between the Bishop score and the probability of vaginal delivery, with an increasing probability of vaginal delivery for higher Bishop scores before and after the 24 h following cervical ripening (Fig. 2).
After cervical ripening by vaginal prostaglandin E2, 55.6 % of our patients delivered vaginally. This result is in line with the vaginal delivery rates ranging from 53.8%–81% reported by the main studies that have assessed the use of vaginal prostaglandin E2 in the induction of labor in patients with one previous cesarean section [13,15–18] (Table 4). Only one randomized trial published in 1993 studied the vaginal delivery rate with vaginal prostaglandin versus oxytocin in 42 patients with one previous cesarean section [14]. The vaginal delivery rate in the prostaglandin group was 81 % compared to 71.4 % in the oxytocin group, but the patients included had a Bishop score above 6 in almost 50 % of cases. The larger retrospective study conducted in 2010 by Dekker et al. reported a vaginal delivery rate of 51.4 % in 586 patients with one previous cesarean section and whose labor was induced by prostaglandin alone and a vaginal delivery rate of 60.2 % if prostaglandin was combined with oxytocin [17]. Few retrospective studies have evaluated prostaglandin as a cervical ripening method in patients with one previous cesarean section, in populations ranging from 54 to 366 patients
Table 3 Neonatal outcomes according to the mode of delivery after cervical ripening by the intravaginal dinoprostone device. Characteristics of newborn
Total n = 153
Vaginal delivery n = 85
Cesarean section n = 68
p
Birth weight, grams 5-min Apgar score 5-min Apgar score less than 7 Arterial cord blood pH Arterial cord blood pH less than 7.10 Cord blood lactate, mmol/L Need for resuscitation at birth Transfer to neonatal intensive care unit Respiratory distress
3238 (518) 9.8(0.8) 2.6 % (n = 4) 7.23(0.09) 7.4 %(n = 11/148) 4.5(2.5) 8.5 %(n = 13) 6.5 % (n = 10) 6.5 % (n = 10)
3226 (318) 9.8 (0.8) 1.2 % (n = 1) 7.23 (0.08) 4.9 % (n = 4/82) 4.4 (1.9) 5.8 %(n = 5) 4.7 % (n = 4) 3.5 % (n = 3)
3255 (518) 9.6 (0.8) 4.4 % (n = 3) 7.22 (0.08) 10.6 % (n = 7/66) 4.5 (1.9) 11.7 % (n = 8) 8.8 % (n = 6) 10.2 % (n = 7)
0.75 0.04 0.21 0.82 0.19 0.77 0.20 0.31 0.09
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Table 4 Review of studies evaluating induction of labor by prostaglandin in women with a previous cesarean section. Sample Prostaglandin
Inclusion criteria
Vaginal delivery rate
Uterine rupture rate
Taylor et al, 1993 Randomized trial [14]
21
Prostaglandin E2, 2.5 mg
81.0 %
4.8 % (1)
Kehl et al, 2015 [21]
Prospective multicenter cohort study
112
Vaginal PGE2 gel 1 mg-2 mg Initial dosage of 1 mg, 6 hours after: a dosage of 2 mg 24 hours after: dosages of 2 mg in the morning and after 6 hours
-Singleton pregnancies A prior cesarean section at term
63 %
0.9 % (1)
Grobman et al, 2007 [22]
Prospective observational study
754
Unknown
One prior low transverse cesarean delivery Singleton pregnancy Who underwent a trial of labor at term (greater than 36 + 6 weeks of gestation)
–
0.80 % (6)
Kwee et al, 2006 [12]
Prospective study
323
Prostaglandin E2, sulprostone and misoprostol
One previous cesarean section Deliveries >16 weeks
–
5.3 % (17)
Landon et al, 2004 [11]
Prospective observational study
1153
Misoprostol, dinoprostone, prostaglandin E2 gel
A prior cesarean delivery A singleton pregnancy > 20 weeks of gestation or infant birth weight > 500 g
–
1.1 % (13)
Dekker et al, 2010 Population-based [17] retrospective cohort study
812
Unknown
Singleton pregnancy One previous caesarean section Second birth
53.8 %
1.0 % (8)
Al-Zirqi et al, 2010 [20]
Population-based registry study.
1298
–
1.54 %
Lydon-Rochelle et al, 2001 [9]
Population-based, retrospective cohort
366
Prostin E2 (dinoprostone) tablets 3 mg Pregnancy >28 weeks of gestation repeated after 6 hours, with maximum After previous cesarean section dose of three tablets. Unknown Primiparous women One previous cesarean section, with a livebirth
–
2.45 % (9)
Gomez et al, 2011 Retrospective study [16]
247
PGE2 10 mg dinoprostone vaginal insert A previous cesarean section (by lowsegment transverse incision) A low Bishop score <6 Cephalic presentation at term A live fetus
65.2 %
1.7 % (9)
Agnew et al, 2009 [13]
Retrospective study
54
PGE2 1 mg gel at 6 -hly intervals to a maximum of 4 mg.
74 %
0
Ben-Aroya et al, 2002 [18]
Retrospective cohort study
55
PGE2 tablets of 0.5 mg–1 mg, repeated One previous cesarean section every 6 hours until cervical dilatation of Cephalic presentation at least 3 cm Between 36 weeks and 42 weeks
54.5 %
0
Ravasia et al, 2000 [15]
Retrospective study
172
PGE2 gel at 1–2 mg every 6–12 h to a maximum of 3 doses
60.5 %
2.9 % (5)
Author, year
Study design
[9,13,15,16,18]. One of the main limitations of studies evaluating cervical ripening by prostaglandin has been the inclusion of patients with a Bishop score greater than 6 [17]. And the Bishop score was not available in many studies. Our study is the first to provide information on the clinical evaluation of the cervix initially and 24 h after cervical ripening. 4.2. Uterine rupture Uterine rupture is a serious, potentially life-threatening event that may compromise the neurological status of the infant and result in significant uterine bleeding requiring hysterectomy. A systematic review analyzing the benefits and risks of labor induction in women with a prior cesarean section found rates of uterine rupture between 0.35 % and 4.35 % [19]. However, in this same review, there was no significant difference in the rate of
Singleton pregnancies Cephalic presentation > 37 weeks - Bishop score <9
Previous lower segment cesarean section Cephalic presentation Singleton pregnancy
One previous cesarean delivery
uterine rupture between induced labor and spontaneous vaginal delivery, although uterine rupture is a rare event. A large number of studies have focused on uterine rupture rates in the case of prior cesarean section. Most of these studies are retrospective and based on national registers [9,17,20]. Lydon-Rochelle et al., in 2001, reported a uterine rupture rate of 2.45 % (OR = 15.6, 95 % CI 8.1–30) among the 366 patients whose labor was induced by prostaglandin [9]. Landon et al., in 2004, reported no case of uterine rupture among the 227 patients whose labor was induced by prostaglandin alone, and a rate of 1.4 % (13/926) of uterine rupture when labor was induced by prostaglandin and oxytocin (OR = 3.95, 95 % CI 2.01–7.79) [11]. In 2010, Dekker et al. reported a uterine rupture rate of 0.68 % for induction of labor with prostaglandin alone, 0.82 % for oxytocin labor induction and a rate of 1.8 % for prostaglandin and oxytocin labor induction [17]. This study, as well as that of Landon et al., suggests that the combination of oxytocin
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with prostaglandin may increase the risk of uterine rupture [11,17]. However, most studies are retrospective and raise the question of biases in the data collection. These studies did not always provide information on the clinical evaluation of the cervix, or on the indications or modalities of labor induction (doses administered, pharmaceutical formulation). Uterine rupture was not clearly defined in those studies (complete uterine rupture only or sub-serous uterine rupture). In our study, we noted a rate of 1.3 % of complete uterine rupture. In the two cases, labor was induced by prostaglandin followed by oxytocin. 4.3. Neonatal morbidity A prime consideration when counseling women is the perinatal morbidity and mortality that are directly ascribed to uterine rupture. It remains unclear from published studies how often uterine rupture results in severe perinatal morbidity. In our series, neonatal morbidity appears to be higher in the case of failure of the trial of labor without significant association. Severe neonatal acidosis was present in 7.4 % of the newborns. This rate is similar to the 8.1 % of newborns with an arterial cord blood pH less than 7.10 reported by Gomez et al. [16]. A 5-minute Apgar score less than 7 was found in 2.6 % of newborns, a rate also comparable to the previously reported values of around 3 % [16,21]. In a study comparing labor induction (all methods combined) with spontaneous labor in patients with one previous cesarean, Grobman et al. found no significant difference in neonatal morbidity, despite the increased risk of uterine rupture after labor induction [22]. 4.4. Predictors of vaginal delivery Predictors of vaginal delivery were a history of vaginal delivery, onset of labor following cervical ripening, and a higher Bishop score at admission and after the 24 h following the cervical ripening. The value of predictors is that they identify patients with the highest probability of vaginal delivery, and thus identify those at higher risk of emergency cesarean section. Thus, the identification of prognostic factors for vaginal delivery would help to identify patients for whom it is acceptable to propose cervical ripening. Our results are consistent with the literature. The factors most commonly known to predict vaginal delivery in the case of trial of labor in patients with a previous cesarean section are the history of vaginal delivery, the onset of labor, and a higher Bishop score at the initial admission to the labor room [23–25]. One study has shown in 686 patients with a previous cesarean undergoing induction of labor that the modified Bishop score before induction of labor is an independent factor associated with successful vaginal delivery [26]. This study included patients with Bishop scores ranging from 0 to 12 and only 13 patients had labor induction by prostaglandin. Of the 1,896 patients with a history of cesarean section, 1,294 i.e. 68.2 %) had a trial of labor. But the indications for a repeat cesarean section were not known for the other women, which constitutes a selection bias. The main limitation of our study is its retrospective nature, which raises the problem of the accuracy of the data collected. Further limitations are the lack of a comparison group and the sample size. The fact that women were not managed in a standardized way after the 24 h following the cervical ripening if the labor did not occur and the Bishop score was below 6, constitutes a bias. However, in this case, the most reasonable choice seems to be a cesarean section. The retrospective nature of the study did not allow us to assess patient satisfaction, although this is an important dimension in the management of patients. However, the strengths of the study were knowledge of the Bishop score and of the duration and maximum dose of oxytocin.
7
A larger scale randomized trial comparing pharmacological and mechanical cervical ripening methods would determine the cervical ripening method associated with lower neonatal and maternal morbidity. A recent trial has compared the efficacy and maternal-neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix [27]. The balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low-dose intravenous oxytocin, suggesting the use of a balloon catheter as an alternative to low-dose oxytocin for induction of labor [27]. In addition, it would be interesting to evaluate the duration and cost of hospitalization, as well as patient satisfaction with these different methods of cervical ripening. 5. Conclusion Cervical ripening by prostaglandin is a labor induction method associated with a vaginal delivery rate above 50 % in patients with a previous cesarean section and a low Bishop score. However, there is a risk of uterine rupture, especially when prostaglandin and oxytocin are combined. There is also maternal morbidity in the case of emergency cesarean section. The decision to induce labor with prostaglandin in a woman with a previous cesarean section should take into account predictors of successful vaginal delivery. References [1] Cragin EB. Conservatism in obstetrics. New York Med J 1916. [2] Flamm BL, Lim OW, Jones C, Fallon D, Newman LA, Mantis JK. Vaginal birth after cesarean section: results of a multicenter study. Am J Obstet Gynecol 1988;158:1079–84. [3] Rosen MG, Dickinson JC, Westhoff CL. Vaginal birth after cesarean: a metaanalysis of morbidity and mortality. Obstet Gynecol 1991;77:465–70. [4] Beckett VA, Regan L. Vaginal birth after cesarean: the European experience. Clin Obstet Gynecol 2001;44:594–603. [5] Creanga AA, Bateman BT, Butwick AJ, Raleigh L, Maeda A, Kuklina E, et al. Morbidity associated with cesarean delivery in the United States: is placenta accreta an increasingly important contributor? Am J Obstet Gynecol 2015;213 (384)e1–384, doi:http://dx.doi.org/10.1016/j.ajog.2015.05.002 e11. [6] Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, et al. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol 2006;107:1226–32, doi:http://dx.doi.org/10.1097/01. AOG.0000219750.79480.84. [7] Diemunsch P, Gallot D, Haumonté J-B, Kayem G, Lopez E, Parant O, et al. Accouchement en cas d’utérus cicatriciel : recommandations pour la pratique clinique – texte des recommandations (texte court). J Gynécologie Obs Biol La Reprod 2012;41:824–30, doi:http://dx.doi.org/10.1016/j.jgyn.2012.09.038. [8] American College of Obstetricians and Gynecologists. ACOG Practice bulletin no. 115: vaginal birth after previous cesarean delivery. Obstet Gynecol 2010;116:450–63, doi:http://dx.doi.org/10.1097/AOG.0b013e3181eeb251. [9] Lydon-Rochelle M, Holt VL, Easterling TR, Martin DP. Risk of uterine rupture during labor among women with a prior cesarean delivery. N Engl J Med 2001;345:3–8, doi:http://dx.doi.org/10.1056/NEJM200107053450101. [10] Rageth JC, Juzi C, Grossenbacher H. Delivery after previous cesarean: a risk evaluation. Swiss working group of obstetric and gynecologic institutions. Obstet Gynecol 1999;93:332–7. [11] Landon MB, Hauth JC, Leveno KJ, Spong CY, Leindecker S, Varner MW, et al. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med 2004;351:2581–9, doi:http://dx.doi.org/ 10.1056/NEJMoa040405. [12] Kwee A, Bots ML, Visser GHA, Bruinse HW. Obstetric management and outcome of pregnancy in women with a history of caesarean section in the Netherlands. Eur J Obstet Gynecol Reprod Biol 2006;132:171–6, doi:http://dx. doi.org/10.1016/j.ejogrb.2006.07.017. [13] Agnew G, Turner MJ. Vaginal prostaglandin gel to induce labour in women with one previous caesarean section. J Obstet Gynaecol (Lahore) 2009;29:209– 11, doi:http://dx.doi.org/10.1080/01443610902743789. [14] Taylor AVG SS, Ah-moye M, Mackenzie IZ. A prospective random allocation trial to compare vaginal prostaglandin E 2 with intravenous oxytocin for labour induction in women previously delivered by caesarean section. J Obstet Gynaecol (Lahore) 1993;13:333–6, doi:http://dx.doi.org/10.3109/ 01443619309151705. [15] Ravasia DJ, Wood SL, Pollard JK. Uterine rupture during induced trial of labor among women with previous cesarean delivery. Am J Obstet Gynecol 2000;183:1176–9, doi:http://dx.doi.org/10.1067/mob.2000.109037.
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G Model JOGOH 101699 No. of Pages 8
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[16] Gómez LR, Burgos J, Cobos P, Melchor JC, Osuna C, Centeno M del M, et al. Oxytocin versus dinoprostone vaginal insert for induction of labor after previous cesarean section: a retrospective comparative study. J Perinat Med 2011;39:397–402, doi:http://dx.doi.org/10.1515/JPM.2011.030. [17] Dekker G, Chan A, Luke C, Priest K, Riley M, Halliday J, et al. Risk of uterine rupture in Australian women attempting vaginal birth after one prior caesarean section: a retrospective population-based cohort study. BJOG An Int J Obstet Gynaecol 2010;117:1358–65, doi:http://dx.doi.org/10.1111/j.14710528.2010.02688.x. [18] Ben-Aroya Z, Hallak M, Segal D, Friger M, Katz M, Mazor M. Ripening of the uterine cervix in a post-Cesarean parturient: prostaglandin E 2 versus Foley catheter. J Matern Fetal Neonatal Med 2002;12:42–5, doi:http://dx.doi.org/ 10.1080/jmf.12.1.42.45. [19] McDonagh MS, Osterweil P, Guise J-M. The benefits and risks of inducing labour in patients with prior caesarean delivery: a systematic review. BJOG 2005;112:1007–15, doi:http://dx.doi.org/10.1111/j.1471-0528.2005.00623.x. [20] Al-Zirqi I, Stray-Pedersen B, Forsén L, Vangen S. Uterine rupture after previous caesarean section. BJOG 2010;117:809–20, doi:http://dx.doi.org/10.1111/ j.1471-0528.2010.02533.x. [21] Kehl S, Weiss C, Wamsler M, Beyer J, Dammer U, Heimrich J, et al. Double-balloon catheter and sequential vaginal prostaglandin E2 versus vaginal prostaglandin E2 alone for induction of labor after previous cesarean section. Arch Gynecol Obstet 2015;293:757–65, doi:http://dx.doi.org/10.1007/s00404-015-3907-7.
[22] Grobman WA, Gilbert S, Landon MB, Spong CY, Leveno KJ, Rouse DJ, et al. Outcomes of induction of labor after one prior cesarean. Obstet Gynecol 2007;109:262–9, doi:http://dx.doi.org/10.1097/01.AOG.0000254169. 49346.e9. [23] Landon MB, Leindecker S, Spong CY, Hauth JC, Bloom S, Varner MW, et al. The MFMU Cesarean Registry: factors affecting the success of trial of labor after previous cesarean delivery. Am J Obstet Gynecol 2005;193:1016–23, doi: http://dx.doi.org/10.1016/j.ajog.2005.05.066. [24] Weinstein D, Benshushan A, Tanos V, Zilberstein R, Rojansky N. Predictive score for vaginal birth after cesarean section. Am J Obstet Gynecol 1996;174:192–8. [25] Grobman WA, Lai Y, Landon MB, Spong CY, Leveno KJ, Rouse DJ, et al. Development of a nomogram for prediction of vaginal birth after cesarean delivery. Obstet Gynecol 2007;109:806–12, doi:http://dx.doi.org/10.1097/01. AOG.0000259312.36053.02. [26] Bujold E, Blackwell SC, Hendler I, Berman S, Sorokin Y, Gauthier RJ. Modified Bishop’s score and induction of labor in patients with a previous cesarean delivery. Am J Obstet Gynecol 2004;191:1644–8, doi:http://dx.doi.org/ 10.1016/j.ajog.2004.03.075. [27] Sarreau M, Isly H, Poulain P, Fontaine B, Morel O, Villemonteix P, et al. Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: a randomized controlled trial. Acta Obstet Gynecol Scand 2019, doi:http://dx.doi.org/10.1111/aogs.13712.
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Journal of Gynecology Obstetrics and Human Reproduction xxx (2019) xxx–xxx
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Original Article
Cervical ripening by prostaglandin E2 in patients with a previous cesarean section Hanane Bouchghoula,b,* , Suzanne Zeinoa , Marie Houlliera , Marie-Victoire Senata,b a b
Assistance Publique-Hôpitaux De Paris, Bicêtre Hospital, Department of Gynecology-Obstetrics, Le Kremlin-Bicêtre, France Université Paris-Saclay, Univ. Paris-Sud, UVSQ, CESP, INSERM, Villejuif, 94807 France
A R T I C L E I N F O
A B S T R A C T
Article history: Received 12 November 2019 Received in revised form 22 January 2020 Accepted 22 January 2020 Available online xxx
Objective: To assess the efficacy and safety of prostaglandin in inducing labor in pregnant women with one previous cesarean section. Secondly, to evaluate predictors of successful vaginal delivery in cervical ripening by prostaglandin in these women. Study design: This was an observational, retrospective, single-center study conducted in a type 3 maternity unit at Bicêtre University Hospital between January 1, 2013 and December 31, 2016. Patients with one previous cesarean section, a singleton pregnancy, a fetus in the cephalic presentation with a medical indication for induction of labor and an unfavorable cervix (Bishop score less than 6) were included in the study. Cervical ripening was performed using a dinoprostone intravaginal device for a duration of 24 h. Results: A total of 153 patients were included in the study. The rate of vaginal delivery was 55.6 % (85/153) overall and 78.3 % (36/46) in the subgroup of 46 women with a previous vaginal delivery before or after the cesarean section. There was no difference in neonatal and maternal morbidity (defined by intraoperative wounds or postpartum hemorrhage or uterine rupture) and mortality between women who delivered vaginally and women who had a cesarean section. The two cases of complete uterine rupture have been reported for patients whose labor was induced by intravaginal prostaglandin followed by intravenous oxytocin. The total maternal morbidity rate was 11.8 % (n = 8/68) in the case of emergency cesarean section. Predictors of vaginal delivery were a history of vaginal delivery, the onset of labor following cervical ripening, and a higher Bishop score before and after the 24 h following the cervical ripening. Conclusion: Cervical ripening by prostaglandin after previous cesarean delivery has a 56 % success rate, with a 1.3 % risk of uterine rupture, especially when prostaglandin is combined with oxytocin. Low-risk patients should be identified to propose cervical ripening by prostaglandin. © 2020 Elsevier Masson SAS. All rights reserved.
Keywords: Cervical ripening Labor induction Previous cesarean section Prostaglandins
1. Introduction Before the 1980s, vaginal delivery was contraindicated in the event of a previous cesarean section, and an iterative cesarean section was systematically performed according to Cragin's adage "a cesarean section one day, a cesarean section always" [1]. From the 1990s, after the publication of several studies whose results were in favor of trial of labor after a cesarean section, with vaginal delivery rates of 75 %, trial of labor was strongly encouraged [2,3].
* Corresponding author at: Department of Obstetrics and Gynecology, AP-HP, Bicêtre Hospital, 78, avenue du Général Leclerc, 94275 Le Kremlin-Bicêtre, Cedex, France. E-mail address: [email protected] (H. Bouchghoul).
Primary cesarean section rates have increased worldwide in the last 30 years [4]. Cervical ripening after cesarean section remains controversial considering the risks of uterine rupture and maternal and neonatal morbidity. But the main complications of iterative cesarean section are risks of hemorrhage, thromboembolism, infection, and of urological, gastrointestinal and vascular wounds [5]. Long-term risks are those of repeat cesarean deliveries as uterine rupture in a subsequent pregnancy, and placental insertion anomalies (placenta previa, accreta, percreta), which cause morbidity and mortality (hysterectomy, blood transfusion, perioperative wounds) [6]. So, neither repeat cesarean delivery nor trial of labor is risk-free. To date, there is no consensus regarding induction of labor, especially cervical ripening in the case of previous cesarean section. French recommendations encourage vaginal delivery after a cesarean section delivery, particularly in the case of spontaneous
http://dx.doi.org/10.1016/j.jogoh.2020.101699 2468-7847/© 2020 Elsevier Masson SAS. All rights reserved.
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labor [7]. But they specify that the greatest caution should be exercised because of the significant increase in the risk of uterine rupture. The decision to use prostaglandins as an induction method should consider obstetrical and maternal factors that may influence the success of vaginal delivery [7]. ACOG updated its recommendations by encouraging trial of labor and not contraindicating the use of prostaglandin, after having informed the patient about the increased risk of uterine rupture [8]. However, induction of labor in patients with a previous cesarean section remains highly debated, especially because of the risk of uterine rupture [9–12]. The risk of uterine rupture was increased among women whose labor was induced by prostaglandin, as compared with those who went into spontaneous labor [9,11,12]. But these results are controversial because of many biases, including retrospective studies, the lack of distinction between complete and sub-serous uterine rupture, the modalities of diagnosis of uterine rupture, the lack of information on the type of prostaglandin, the doses used and the management during labor. In other studies, the risk of uterine rupture was not increased in patients with cervical ripening by prostaglandin [13,14]. A randomized trial included 42 women who were assigned to either prostaglandin or oxytocin for the induction of labor in the case of a previous cesarean section [14]. In the prostaglandin group, the cesarean section rate was lower than in the oxytocin group, with no difference in the uterine rupture rate. However, few data are available in the literature on the use of vaginal prostaglandin in the case of previous cesarean section or on predictors of vaginal delivery in patients with a prior cesarean undergoing cervical ripening. The aim of our study was to assess the efficacy and safety of prostaglandin in inducing labor in pregnant women with one previous cesarean section. The second objective was to evaluate predictors of successful vaginal delivery in cervical ripening in these women.
2. Material and methods This was an observational, retrospective, single-center study conducted in a type 3 maternity unit at Bicêtre University Hospital between January 1, 2013 and December 31, 2016. Patients with one previous cesarean section, a singleton pregnancy, a fetus in the cephalic presentation with a medical indication for induction of labor and an unfavorable cervix (Bishop score less than 6) were included in the study. The exclusion criteria were multiple pregnancies, more than one previous caesarean section, placenta previa, or any other contraindication to vaginal delivery, termination of pregnancy or stillbirth. Cervical ripening was performed using a sustained-release dinoprostone intravaginal device. The device was placed at the posterior vaginal fornix for a duration of 24 h in the absence of complications. Fetal heart rate monitoring was performed 30 min before and 2 h after the insertion of the dinoprostone intravaginal device, then 6 h and 12 h after, or if uterine contractions, bleeding or rupture of membranes occurred. If labor started during cervical ripening, the intravaginal device was removed and the patient was admitted to the labor ward. Otherwise, after 24 h of cervical ripening, if the Bishop score was greater than or equal to 6, the labor induction was continued by intravenous oxytocin associated with amniotomy. If the Bishop score was less than 6, the decision was left to the obstetrician after discussion with the patient. The obstetrician had the choice of performing a cesarean section for cervical ripening failure or continuing the induction of labor with amniotomy, intravenous oxytocin or prostaglandin. Before the cervical ripening by the intravaginal dinoprostone device, the patient was given information on the modalities of labor induction, success rate, and the risks of uterine rupture.
Table 1 Maternal characteristics and modalities of cervical ripening by the intravaginal prostaglandin device in patients with a previous cesarean section and a Bishop score of less than 6.
Maternal age, years Pre-pregnancy BMI, kg/m2 BMI at the end of pregnancy, kg/m2 Primiparas History of vaginal delivery, n (%) Gestational age at the previous cesarean section, median Planned previous cesarean section Interval between previous cesarean section and cervical ripening, months Gestational diabetes Gestational hypertension/ preeclampsia. Fetal growth restriction Preterm rupture of membranes before 36 WG Gestational age at cervical ripening, weeks of gestation Bishop score at admission Bishop score 24 hours after cervical ripening Events during cervical ripening Fetal distress Rupture of membranes Loss of the device Bleeding Duration of cervical ripening, hours Intravenous oxytocin during labor Duration of intravenous oxytocin, hours Maximum dose of intravenous oxytocin, mIU/mL Duration of labor, hours Interval between cervical ripening and birth, hours
Total n = 153
Vaginal delivery n = 85
Cesarean section n = 68
p
32 [28–35] 26.1 [23.1–29.4] 31.6 [28.5–34.3] 107 (70.0 %) 46 (30.0 %) 40+0[38-40] 28 (18.3 %) 48 [36–72]
32 [28–35] 26.0 [23.1–29.1] 31.6 [28.4–34.0] 49 (57.6 %) 36 (42.3 %) 39+0 [37+3-40+2] 12 (17.6 %) 48 [36–84]
32 [28–35] 26.5 [23.2–29.7] 31.6 [28.7–34.5] 58 (85.3 %) 10 (14.7 %) 40+0 [38+0–40+0] 16 (18.8 %) 48 [27–72]
0.66 0.94 0.81 <0.001 <0.001 0.70 0.85 0.42
55 (36 %) 11 (7.2 %) 15 (9.8 %) 2 (1.3 %) 39+4 [38+3–41+1] 2 [1–2] 4 [2–5]
29 (34.1 %) 4 (4.7 %) 6 (7.1 %) 2 (2.3 %) 39+4 [38+1–41+0] 2 [1–3] 5 [3–6]
26 (38.2 %) 7 (10.3 %) 9 (13.2 %) 0 (0.0 %) 39+5 [38+4–41+1] 2 [1,2] 3 [2–5]
0.60 0.22 0.27 0.20 0.34 0.01 <0.001
22 (14.4 %) 11 (7.2 %) 13 (8.5 %) 4 (2.6 %) 16.0 [9.5–24.0] 96 (62.7 %) 3 [2–7] 12.5 [10.0–20.0] 4.0 [2.0–7.0] 21.0 [14.0–26.0]
8 (9.4 %) 5 (5.9 %) 9 (10.6 %) 2 (2.3 %) 13.0 [7.5–24.0] 59 (69.4 %) 4 [2–7] 15.0 [10.0–20.0] 5 .0[3.0–7.0] 18.0 [12.0–28.0]
14 (20.6 %) 6 (8.8 %) 4 (5.9 %) 2 (2.9 %) 22.5 [12.0–24.0] 37 (54.4 %) 3 [1–6] 10.0 [8.7–17.5] 2 [0–4.7] 24.0 [15.2–26.0]
0.05 0.54 0.39 1.00 0.003 0.06 0.37 0.17 <0.001 0.31
Data are expressed as the median with the interquartile range for quantitative variables and as a percentage for qualitative data.
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3
2.1. Outcomes
3.1. Maternal and obstetrical characteristics
The primary outcome parameter was the vaginal delivery rate. Secondary outcome measures were the neonatal outcome parameters (e.g. arterial cord blood pH, and lactate, 5-minute Apgar score, postpartum admission to neonatal care unit) and maternal morbidity defined by post-partum hemorrhage, uterine rupture, or a wound complication in the case of cesarean section.
The median age of patients was 32 years [28–35] and the average BMI at the beginning of pregnancy was 27 kg/m2 (4.9) (Table 1). The median parity was 1 [1–2], with 46 (30 %) who had a previous vaginal delivery before and/or after cesarean section. The main indications for the first cesarean section were fetal distress in 40 % of cases, breech presentation in 13.1 %, failure to progress in 12.4 %, vascular diseases (preeclampsia, retroplacental hematoma, HELLP syndrome) in 11.7 % and failure to induce labor in 10.5 %. The main indications for cervical ripening were prolonged pregnancy in 29.4 % of cases (45), rupture of membranes at term in 22.2 % (34), gestational diabetes in 17.0 % (26), fetal indication (no fetal movements, oligohydramnios or fetal heart abnormalities) in 11.1 % (17), hypertensive disorders at the end of pregnancy in 8.5 % (13), maternal disease in 6.5 % (10), small for gestational age in 2.0 % (3) and others (cholestasis, bleeding, maternal hyperthermia) in 3.3 % (5).
2.2. Statistics Data for quantitative variables are expressed as mean with standard deviation or preferably as medians with interquartile interval, with the 1 st and 3rd quartiles corresponding to the 25th and 75th percentiles [Q1-Q3]. Qualitative data are expressed as percentages. Simple comparisons were made by using the χ2 (or exact Fisher) test for qualitative variables and Student's t-test for quantitative variables. A logistic regression with estimation of the odds ratio was performed to study the association between each explanatory variable and vaginal delivery. Regarding the Bishop score, which is a continuous variable, we first tested the linearity of the relationship before performing a logistic regression. We performed a multivariate analysis to consider confusion biases. Adjustment was made for the variables identified in the univariate analysis. The statistical analysis was performed using Stata 14 software (StataCorp LP, College Station, TX, USA). This study received the approval of the Institutional Review Board (CEROG: n 2020-OBS-0101). 3. Results Of 14 390 patients delivered in the maternity unit at the University Hospital of Bicêtre between January 2013 and December 2016, 1896 had one previous cesarean delivery (13.1 %) and of these 1294 (68.2 %) had a trial of labor. Of these 1294 patients, 155 (12.0 %) had a labor induction by vaginal prostaglandin E2 and two of these were excluded: one patient whose fetus had fetal ascites of undetermined origin and one patient who received an intracervical balloon after cervical ripening by a dinoprostone intrauterine device. A total of 153 patients were therefore included in the study between January 1, 2013 and December 31, 2016.
3.2. Cervical ripening Events that occurred during cervical ripening are presented in Table 1: 22 patients (14.4 %) had fetal distress, 11 (7.2 %) had rupture of membranes, 13 (8.5 %) lost the device, and 4 (2.6 %) had bleeding. The average duration of insertion of the dinoprostone intravaginal device was 16 h (7.6). The average interval between the beginning of cervical ripening and birth was 20 h and 18 min (8.5). Intravenous oxytocin was administered in 62.1 % of cases (96/153), with a mean duration of the intravenous oxytocin perfusion of 4.3 h (3.1). The maximum dose of oxytocin administered was 14.5 mIU/min ((4.3). 3.3. Mode of delivery The vaginal delivery rate was 55.6 % (85/153), including 22.4 % (19/85) of cases of instrumental vaginal delivery (Table 2). Among the 46 women with a previous vaginal delivery before or after the cesarean section, the vaginal delivery rate was 78.3 % (36/46). Fig. 1 shows the rate of vaginal delivery according to the onset of labor and, if not, according to the cervical changes during cervical ripening by dinoprostone. The vaginal delivery rate was higher for patients who entered labor than for patients who did not: 79.2 % (38/48) versus 42.9 % (47/105).
Table 2 Predictors of vaginal delivery after cervical ripening by the intravaginal dinoprostone device, for patients with one previous cesarean section.
Maternal age more than 35 years BMI more than 40 kg/m2 at the end of pregnancy History of vaginal delivery History of planned cesarean Suspicion of macrosomia (fetal weight estimation above the 95th percentile) Suspicion of fetal growth retardation (fetal weight estimation below the 10th percentile) Gestational age above 37 WG Bishop score before cervical ripening Bishop score after the 24 hours following cervical ripening Onset of labor during the 24 hours following cervical ripening
Vaginal delivery n = 85
Cesarean section n = 68
p
OR*
ORa**
25.9 % (22) 7.1 % (6) 42.3 % (36) 81.2 % (69) 1.2 % (1)
25.0 % (17) 7.3 % (5) 14.7 % (10) 82.3 % (56) 1.5 % (1)
0.90 1.00 <0.01 0.85 1.0
1.05 [0.50–2.18] 0.96 [0.28–3.28] 4.26 [1.92–9.46] 0.92 [0.40–2.11] 0.80 [0.05–13.00]
0.63 [0.27–1.49] 0.53 [0.13–2.19] 4.46 [1.90–10.46] 1.40 [0.55–3.56] 0.32 [0.02–6.53]
3.5 % (3)
8.6 % (8)
0.06
0.26 [0.07–1.08]
0.30 [0.07–1.26]
88.2 % (75) 1.91 (0.97) 4.85 (2.17)
91.2 % (62) 1.5 (097) 3.32 (215)
0.55 0.008 <0.001
0.73 [0.25–2.11] 1.59 [1.13–2.24] R* 1.41 [1.18–1.67]
2.82 [0.86–9.26] 1.63 [1.14–2.36] 1.34 [1.11–1.62]
44.7 % (38)
14.7 % (10)
<0.001
4.69 [2.12–10.39]
3.83 [1.63–9.02]
BMI: body mass index, WG: weeks of gestation. * Odds ratio with its 95 % confidence interval (95 % CI). ** Odds ratio adjusted for the Bishop score before cervical ripening, the history of a previous vaginal delivery, the body mass index at the end of the pregnancy, and the suspicion of fetal growth retardation.
Please cite this article in press as: H. Bouchghoul, et al., Cervical ripening by prostaglandin E2 in patients with a previous cesarean section, J Gynecol Obstet Hum Reprod (2020), https://doi.org/10.1016/j.jogoh.2020.101699
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Fig. 1. Flow chart and rate of vaginal delivery according to the beginning of labor and cervical changes during cervical ripening by dinoprostone.
The cesarean section rate was 44.4 % (68/153), with a rate of failure to induce labor (cesarean section cervix below 6 cm) of 36.6 % (56/153). The main indication for cesarean section was fetal distress in 52.9 % of cases (n = 36/68). The absence of cervical changes after 24 h of cervical ripening was the second main indication for cesarean section with a rate of 27.9 % (n = 19/68). The third cause of cesarean section was failure to induce labor by intravenous oxytocin, with a rate of 11.8 % (n = 8/68). Other indications were failure to progress (n = 4/68, 5.9 %) and bleeding (n = 1/68, 1.5 %). Among the 68 cesarean sections, four were performed during the 24 h following cervical ripening and before labor, three for fetal distress and one for bleeding. After 24 h of cervical ripening, 18.3 % (28/153) of women had a Bishop score below 6 and were not in labor. A cesarean section was decided for 23 of these 28 women (i.e. 82.1 %) by the obstetrician, after discussion with the patient. 3.4. Maternal morbidity Postpartum hemorrhage was the main maternal complication and was observed in 4.0 % (6/153) of women, all of whom delivered vaginally. Among these, 5 were resolved by the administration of sulprostone and one was resolved after uterine revision and administration of oxytocin. There was no severe postpartum hemorrhage. Two cases of complete uterine rupture and two of serous uterine rupture were observed. For the two cases of complete uterine rupture, after 24 h of cervical ripening by prostaglandin, oxytocin was perfused to induce labor. For the first case, after 5 h of intravenous oxytocin at a maximum dose of 12.5 mIU/min, the
cesarean section was performed for fetal distress. The complete uterine rupture with the fetal shoulder through the hysterotomy was diagnosed during cesarean section. A 3580-gram neonate was born with a 5-minute Apgar score of 10 and an arterial cord blood pH of 7.24. For the second case, after 1 h of intravenous oxytocin at a maximum dose of 5 mIU/min, the cesarean section was performed for fetal distress. The complete uterine rupture occurred with a vertical slit line and the fetus in an intraabdominal position. The 2790-gram neonate was born with a 5-minute Apgar score of 6, an arterial cord blood pH of 6.88 and lactate at 12 mmol/L. There were no maternal complications for these cases. One case of uterine rupture under the serous membrane was diagnosed during a uterine revision performed for nonplacental detachment, without hemorrhage. The second one was diagnosed during a cesarean performed for fetal distress with no maternal or fetal consequences. Five patients who had an emergency cesarean section had intraoperative wounds, with 2 bladder wounds, 2 slit lines on the uterus and 1 uterine artery wound, respectively. Indications for cesarean section were fetal distress in three cases and failure to induce labor in two. One patient required a second surgery for a wall hematoma that occurred 3 h after the procedure. So, the maternal morbidity rate was 11.8 % (n = 8/68) in the case of emergency cesarean section. 3.5. Predictors of vaginal delivery Predictors significantly associated with vaginal delivery after cervical ripening with prostaglandin E2 were a previous vaginal
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3.6. Neonatal morbidity The average birth weight of newborns was 3238 g (518) (Table 3). Neonatal acidosis with an arterial cord blood pH less than 7.00 was observed in 4.1 % of newborns (6/148). The rate of respiratory distress was 6.5 % (10/153). There was no significant difference in neonatal outcomes according to the mode of delivery. However, there was a trend to more neonatal complications (arterial cord blood pH less than 7.10, 5-minute Apgar score less than 7, resuscitation in the birth room, respiratory distress, transfer to neonatal care unit) in the case of cesarean delivery. No maternal, fetal or neonatal deaths were reported. 4. Discussion In our series, the vaginal delivery rate after prostaglandin cervical ripening for women with one previous cesarean section was 55.6 %, with a uterine rupture rate of 1.3 % as expected. Among women who entered labor after cervical ripening, the vaginal delivery rate was 79.2 %, whereas it was 42.9 % for patients who did not. However, among women delivered by emergency cesarean section, the maternal morbidity rate was 11.8 %. There was no difference in neonatal and maternal morbidity and mortality between women who delivered vaginally and women who had a cesarean section. The two cases of complete uterine rupture were reported for patients whose labor was induced by intravenous oxytocin after 24 h of prostaglandin cervical ripening. 4.1. Vaginal delivery rate Fig. 2. Prediction of vaginal delivery according to. (a) the initial Bishop score. Modeling using a logistic regression, after adjustment for the history of a previous vaginal delivery, the body mass index at the end of the pregnancy, and the suspicion of fetal growth retardation. (b) the Bishop score after 24 h of cervical ripening. Modeling using a logistic regression, after adjustment for the initial Bishop score, the onset of labor following cervical ripening, the history of a previous vaginal delivery, the body mass index at the end of the pregnancy, and the suspicion of fetal growth retardation.
delivery (ORa = 4.46 [95 % CI: 1.90–10.46], p = 0.001) and onset of labor after cervical ripening (ORa = 3.83 [95 % CI: 1.63–9.02], p = 0.002) (Table 2). This relation was adjusted for the Bishop score before cervical ripening, the history of a previous vaginal delivery, the body mass index at the end of the pregnancy, and the suspicion of fetal growth retardation. Modeling showed a significant association between the Bishop score and the probability of vaginal delivery, with an increasing probability of vaginal delivery for higher Bishop scores before and after the 24 h following cervical ripening (Fig. 2).
After cervical ripening by vaginal prostaglandin E2, 55.6 % of our patients delivered vaginally. This result is in line with the vaginal delivery rates ranging from 53.8%–81% reported by the main studies that have assessed the use of vaginal prostaglandin E2 in the induction of labor in patients with one previous cesarean section [13,15–18] (Table 4). Only one randomized trial published in 1993 studied the vaginal delivery rate with vaginal prostaglandin versus oxytocin in 42 patients with one previous cesarean section [14]. The vaginal delivery rate in the prostaglandin group was 81 % compared to 71.4 % in the oxytocin group, but the patients included had a Bishop score above 6 in almost 50 % of cases. The larger retrospective study conducted in 2010 by Dekker et al. reported a vaginal delivery rate of 51.4 % in 586 patients with one previous cesarean section and whose labor was induced by prostaglandin alone and a vaginal delivery rate of 60.2 % if prostaglandin was combined with oxytocin [17]. Few retrospective studies have evaluated prostaglandin as a cervical ripening method in patients with one previous cesarean section, in populations ranging from 54 to 366 patients
Table 3 Neonatal outcomes according to the mode of delivery after cervical ripening by the intravaginal dinoprostone device. Characteristics of newborn
Total n = 153
Vaginal delivery n = 85
Cesarean section n = 68
p
Birth weight, grams 5-min Apgar score 5-min Apgar score less than 7 Arterial cord blood pH Arterial cord blood pH less than 7.10 Cord blood lactate, mmol/L Need for resuscitation at birth Transfer to neonatal intensive care unit Respiratory distress
3238 (518) 9.8(0.8) 2.6 % (n = 4) 7.23(0.09) 7.4 %(n = 11/148) 4.5(2.5) 8.5 %(n = 13) 6.5 % (n = 10) 6.5 % (n = 10)
3226 (318) 9.8 (0.8) 1.2 % (n = 1) 7.23 (0.08) 4.9 % (n = 4/82) 4.4 (1.9) 5.8 %(n = 5) 4.7 % (n = 4) 3.5 % (n = 3)
3255 (518) 9.6 (0.8) 4.4 % (n = 3) 7.22 (0.08) 10.6 % (n = 7/66) 4.5 (1.9) 11.7 % (n = 8) 8.8 % (n = 6) 10.2 % (n = 7)
0.75 0.04 0.21 0.82 0.19 0.77 0.20 0.31 0.09
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Table 4 Review of studies evaluating induction of labor by prostaglandin in women with a previous cesarean section. Sample Prostaglandin
Inclusion criteria
Vaginal delivery rate
Uterine rupture rate
Taylor et al, 1993 Randomized trial [14]
21
Prostaglandin E2, 2.5 mg
81.0 %
4.8 % (1)
Kehl et al, 2015 [21]
Prospective multicenter cohort study
112
Vaginal PGE2 gel 1 mg-2 mg Initial dosage of 1 mg, 6 hours after: a dosage of 2 mg 24 hours after: dosages of 2 mg in the morning and after 6 hours
-Singleton pregnancies A prior cesarean section at term
63 %
0.9 % (1)
Grobman et al, 2007 [22]
Prospective observational study
754
Unknown
One prior low transverse cesarean delivery Singleton pregnancy Who underwent a trial of labor at term (greater than 36 + 6 weeks of gestation)
–
0.80 % (6)
Kwee et al, 2006 [12]
Prospective study
323
Prostaglandin E2, sulprostone and misoprostol
One previous cesarean section Deliveries >16 weeks
–
5.3 % (17)
Landon et al, 2004 [11]
Prospective observational study
1153
Misoprostol, dinoprostone, prostaglandin E2 gel
A prior cesarean delivery A singleton pregnancy > 20 weeks of gestation or infant birth weight > 500 g
–
1.1 % (13)
Dekker et al, 2010 Population-based [17] retrospective cohort study
812
Unknown
Singleton pregnancy One previous caesarean section Second birth
53.8 %
1.0 % (8)
Al-Zirqi et al, 2010 [20]
Population-based registry study.
1298
–
1.54 %
Lydon-Rochelle et al, 2001 [9]
Population-based, retrospective cohort
366
Prostin E2 (dinoprostone) tablets 3 mg Pregnancy >28 weeks of gestation repeated after 6 hours, with maximum After previous cesarean section dose of three tablets. Unknown Primiparous women One previous cesarean section, with a livebirth
–
2.45 % (9)
Gomez et al, 2011 Retrospective study [16]
247
PGE2 10 mg dinoprostone vaginal insert A previous cesarean section (by lowsegment transverse incision) A low Bishop score <6 Cephalic presentation at term A live fetus
65.2 %
1.7 % (9)
Agnew et al, 2009 [13]
Retrospective study
54
PGE2 1 mg gel at 6 -hly intervals to a maximum of 4 mg.
74 %
0
Ben-Aroya et al, 2002 [18]
Retrospective cohort study
55
PGE2 tablets of 0.5 mg–1 mg, repeated One previous cesarean section every 6 hours until cervical dilatation of Cephalic presentation at least 3 cm Between 36 weeks and 42 weeks
54.5 %
0
Ravasia et al, 2000 [15]
Retrospective study
172
PGE2 gel at 1–2 mg every 6–12 h to a maximum of 3 doses
60.5 %
2.9 % (5)
Author, year
Study design
[9,13,15,16,18]. One of the main limitations of studies evaluating cervical ripening by prostaglandin has been the inclusion of patients with a Bishop score greater than 6 [17]. And the Bishop score was not available in many studies. Our study is the first to provide information on the clinical evaluation of the cervix initially and 24 h after cervical ripening. 4.2. Uterine rupture Uterine rupture is a serious, potentially life-threatening event that may compromise the neurological status of the infant and result in significant uterine bleeding requiring hysterectomy. A systematic review analyzing the benefits and risks of labor induction in women with a prior cesarean section found rates of uterine rupture between 0.35 % and 4.35 % [19]. However, in this same review, there was no significant difference in the rate of
Singleton pregnancies Cephalic presentation > 37 weeks - Bishop score <9
Previous lower segment cesarean section Cephalic presentation Singleton pregnancy
One previous cesarean delivery
uterine rupture between induced labor and spontaneous vaginal delivery, although uterine rupture is a rare event. A large number of studies have focused on uterine rupture rates in the case of prior cesarean section. Most of these studies are retrospective and based on national registers [9,17,20]. Lydon-Rochelle et al., in 2001, reported a uterine rupture rate of 2.45 % (OR = 15.6, 95 % CI 8.1–30) among the 366 patients whose labor was induced by prostaglandin [9]. Landon et al., in 2004, reported no case of uterine rupture among the 227 patients whose labor was induced by prostaglandin alone, and a rate of 1.4 % (13/926) of uterine rupture when labor was induced by prostaglandin and oxytocin (OR = 3.95, 95 % CI 2.01–7.79) [11]. In 2010, Dekker et al. reported a uterine rupture rate of 0.68 % for induction of labor with prostaglandin alone, 0.82 % for oxytocin labor induction and a rate of 1.8 % for prostaglandin and oxytocin labor induction [17]. This study, as well as that of Landon et al., suggests that the combination of oxytocin
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with prostaglandin may increase the risk of uterine rupture [11,17]. However, most studies are retrospective and raise the question of biases in the data collection. These studies did not always provide information on the clinical evaluation of the cervix, or on the indications or modalities of labor induction (doses administered, pharmaceutical formulation). Uterine rupture was not clearly defined in those studies (complete uterine rupture only or sub-serous uterine rupture). In our study, we noted a rate of 1.3 % of complete uterine rupture. In the two cases, labor was induced by prostaglandin followed by oxytocin. 4.3. Neonatal morbidity A prime consideration when counseling women is the perinatal morbidity and mortality that are directly ascribed to uterine rupture. It remains unclear from published studies how often uterine rupture results in severe perinatal morbidity. In our series, neonatal morbidity appears to be higher in the case of failure of the trial of labor without significant association. Severe neonatal acidosis was present in 7.4 % of the newborns. This rate is similar to the 8.1 % of newborns with an arterial cord blood pH less than 7.10 reported by Gomez et al. [16]. A 5-minute Apgar score less than 7 was found in 2.6 % of newborns, a rate also comparable to the previously reported values of around 3 % [16,21]. In a study comparing labor induction (all methods combined) with spontaneous labor in patients with one previous cesarean, Grobman et al. found no significant difference in neonatal morbidity, despite the increased risk of uterine rupture after labor induction [22]. 4.4. Predictors of vaginal delivery Predictors of vaginal delivery were a history of vaginal delivery, onset of labor following cervical ripening, and a higher Bishop score at admission and after the 24 h following the cervical ripening. The value of predictors is that they identify patients with the highest probability of vaginal delivery, and thus identify those at higher risk of emergency cesarean section. Thus, the identification of prognostic factors for vaginal delivery would help to identify patients for whom it is acceptable to propose cervical ripening. Our results are consistent with the literature. The factors most commonly known to predict vaginal delivery in the case of trial of labor in patients with a previous cesarean section are the history of vaginal delivery, the onset of labor, and a higher Bishop score at the initial admission to the labor room [23–25]. One study has shown in 686 patients with a previous cesarean undergoing induction of labor that the modified Bishop score before induction of labor is an independent factor associated with successful vaginal delivery [26]. This study included patients with Bishop scores ranging from 0 to 12 and only 13 patients had labor induction by prostaglandin. Of the 1,896 patients with a history of cesarean section, 1,294 i.e. 68.2 %) had a trial of labor. But the indications for a repeat cesarean section were not known for the other women, which constitutes a selection bias. The main limitation of our study is its retrospective nature, which raises the problem of the accuracy of the data collected. Further limitations are the lack of a comparison group and the sample size. The fact that women were not managed in a standardized way after the 24 h following the cervical ripening if the labor did not occur and the Bishop score was below 6, constitutes a bias. However, in this case, the most reasonable choice seems to be a cesarean section. The retrospective nature of the study did not allow us to assess patient satisfaction, although this is an important dimension in the management of patients. However, the strengths of the study were knowledge of the Bishop score and of the duration and maximum dose of oxytocin.
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A larger scale randomized trial comparing pharmacological and mechanical cervical ripening methods would determine the cervical ripening method associated with lower neonatal and maternal morbidity. A recent trial has compared the efficacy and maternal-neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix [27]. The balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low-dose intravenous oxytocin, suggesting the use of a balloon catheter as an alternative to low-dose oxytocin for induction of labor [27]. In addition, it would be interesting to evaluate the duration and cost of hospitalization, as well as patient satisfaction with these different methods of cervical ripening. 5. Conclusion Cervical ripening by prostaglandin is a labor induction method associated with a vaginal delivery rate above 50 % in patients with a previous cesarean section and a low Bishop score. However, there is a risk of uterine rupture, especially when prostaglandin and oxytocin are combined. There is also maternal morbidity in the case of emergency cesarean section. The decision to induce labor with prostaglandin in a woman with a previous cesarean section should take into account predictors of successful vaginal delivery. References [1] Cragin EB. Conservatism in obstetrics. New York Med J 1916. [2] Flamm BL, Lim OW, Jones C, Fallon D, Newman LA, Mantis JK. Vaginal birth after cesarean section: results of a multicenter study. Am J Obstet Gynecol 1988;158:1079–84. [3] Rosen MG, Dickinson JC, Westhoff CL. Vaginal birth after cesarean: a metaanalysis of morbidity and mortality. Obstet Gynecol 1991;77:465–70. [4] Beckett VA, Regan L. Vaginal birth after cesarean: the European experience. Clin Obstet Gynecol 2001;44:594–603. [5] Creanga AA, Bateman BT, Butwick AJ, Raleigh L, Maeda A, Kuklina E, et al. Morbidity associated with cesarean delivery in the United States: is placenta accreta an increasingly important contributor? Am J Obstet Gynecol 2015;213 (384)e1–384, doi:http://dx.doi.org/10.1016/j.ajog.2015.05.002 e11. [6] Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, et al. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol 2006;107:1226–32, doi:http://dx.doi.org/10.1097/01. AOG.0000219750.79480.84. [7] Diemunsch P, Gallot D, Haumonté J-B, Kayem G, Lopez E, Parant O, et al. Accouchement en cas d’utérus cicatriciel : recommandations pour la pratique clinique – texte des recommandations (texte court). J Gynécologie Obs Biol La Reprod 2012;41:824–30, doi:http://dx.doi.org/10.1016/j.jgyn.2012.09.038. [8] American College of Obstetricians and Gynecologists. ACOG Practice bulletin no. 115: vaginal birth after previous cesarean delivery. Obstet Gynecol 2010;116:450–63, doi:http://dx.doi.org/10.1097/AOG.0b013e3181eeb251. [9] Lydon-Rochelle M, Holt VL, Easterling TR, Martin DP. Risk of uterine rupture during labor among women with a prior cesarean delivery. N Engl J Med 2001;345:3–8, doi:http://dx.doi.org/10.1056/NEJM200107053450101. [10] Rageth JC, Juzi C, Grossenbacher H. Delivery after previous cesarean: a risk evaluation. Swiss working group of obstetric and gynecologic institutions. Obstet Gynecol 1999;93:332–7. [11] Landon MB, Hauth JC, Leveno KJ, Spong CY, Leindecker S, Varner MW, et al. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med 2004;351:2581–9, doi:http://dx.doi.org/ 10.1056/NEJMoa040405. [12] Kwee A, Bots ML, Visser GHA, Bruinse HW. Obstetric management and outcome of pregnancy in women with a history of caesarean section in the Netherlands. Eur J Obstet Gynecol Reprod Biol 2006;132:171–6, doi:http://dx. doi.org/10.1016/j.ejogrb.2006.07.017. [13] Agnew G, Turner MJ. Vaginal prostaglandin gel to induce labour in women with one previous caesarean section. J Obstet Gynaecol (Lahore) 2009;29:209– 11, doi:http://dx.doi.org/10.1080/01443610902743789. [14] Taylor AVG SS, Ah-moye M, Mackenzie IZ. A prospective random allocation trial to compare vaginal prostaglandin E 2 with intravenous oxytocin for labour induction in women previously delivered by caesarean section. J Obstet Gynaecol (Lahore) 1993;13:333–6, doi:http://dx.doi.org/10.3109/ 01443619309151705. [15] Ravasia DJ, Wood SL, Pollard JK. Uterine rupture during induced trial of labor among women with previous cesarean delivery. Am J Obstet Gynecol 2000;183:1176–9, doi:http://dx.doi.org/10.1067/mob.2000.109037.
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G Model JOGOH 101699 No. of Pages 8
8
H. Bouchghoul et al. / J Gynecol Obstet Hum Reprod xxx (2019) 101699
[16] Gómez LR, Burgos J, Cobos P, Melchor JC, Osuna C, Centeno M del M, et al. Oxytocin versus dinoprostone vaginal insert for induction of labor after previous cesarean section: a retrospective comparative study. J Perinat Med 2011;39:397–402, doi:http://dx.doi.org/10.1515/JPM.2011.030. [17] Dekker G, Chan A, Luke C, Priest K, Riley M, Halliday J, et al. Risk of uterine rupture in Australian women attempting vaginal birth after one prior caesarean section: a retrospective population-based cohort study. BJOG An Int J Obstet Gynaecol 2010;117:1358–65, doi:http://dx.doi.org/10.1111/j.14710528.2010.02688.x. [18] Ben-Aroya Z, Hallak M, Segal D, Friger M, Katz M, Mazor M. Ripening of the uterine cervix in a post-Cesarean parturient: prostaglandin E 2 versus Foley catheter. J Matern Fetal Neonatal Med 2002;12:42–5, doi:http://dx.doi.org/ 10.1080/jmf.12.1.42.45. [19] McDonagh MS, Osterweil P, Guise J-M. The benefits and risks of inducing labour in patients with prior caesarean delivery: a systematic review. BJOG 2005;112:1007–15, doi:http://dx.doi.org/10.1111/j.1471-0528.2005.00623.x. [20] Al-Zirqi I, Stray-Pedersen B, Forsén L, Vangen S. Uterine rupture after previous caesarean section. BJOG 2010;117:809–20, doi:http://dx.doi.org/10.1111/ j.1471-0528.2010.02533.x. [21] Kehl S, Weiss C, Wamsler M, Beyer J, Dammer U, Heimrich J, et al. Double-balloon catheter and sequential vaginal prostaglandin E2 versus vaginal prostaglandin E2 alone for induction of labor after previous cesarean section. Arch Gynecol Obstet 2015;293:757–65, doi:http://dx.doi.org/10.1007/s00404-015-3907-7.
[22] Grobman WA, Gilbert S, Landon MB, Spong CY, Leveno KJ, Rouse DJ, et al. Outcomes of induction of labor after one prior cesarean. Obstet Gynecol 2007;109:262–9, doi:http://dx.doi.org/10.1097/01.AOG.0000254169. 49346.e9. [23] Landon MB, Leindecker S, Spong CY, Hauth JC, Bloom S, Varner MW, et al. The MFMU Cesarean Registry: factors affecting the success of trial of labor after previous cesarean delivery. Am J Obstet Gynecol 2005;193:1016–23, doi: http://dx.doi.org/10.1016/j.ajog.2005.05.066. [24] Weinstein D, Benshushan A, Tanos V, Zilberstein R, Rojansky N. Predictive score for vaginal birth after cesarean section. Am J Obstet Gynecol 1996;174:192–8. [25] Grobman WA, Lai Y, Landon MB, Spong CY, Leveno KJ, Rouse DJ, et al. Development of a nomogram for prediction of vaginal birth after cesarean delivery. Obstet Gynecol 2007;109:806–12, doi:http://dx.doi.org/10.1097/01. AOG.0000259312.36053.02. [26] Bujold E, Blackwell SC, Hendler I, Berman S, Sorokin Y, Gauthier RJ. Modified Bishop’s score and induction of labor in patients with a previous cesarean delivery. Am J Obstet Gynecol 2004;191:1644–8, doi:http://dx.doi.org/ 10.1016/j.ajog.2004.03.075. [27] Sarreau M, Isly H, Poulain P, Fontaine B, Morel O, Villemonteix P, et al. Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: a randomized controlled trial. Acta Obstet Gynecol Scand 2019, doi:http://dx.doi.org/10.1111/aogs.13712.
Please cite this article in press as: H. Bouchghoul, et al., Cervical ripening by prostaglandin E2 in patients with a previous cesarean section, J Gynecol Obstet Hum Reprod (2020), https://doi.org/10.1016/j.jogoh.2020.101699