- Email: [email protected]
A prospective observational study of trial of labor after cesarean in rural India
IJG-08190; No of Pages 5 International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
1
CLINICAL ARTICLE
4Q1
Anjali Soni a, Chanderdeep Sharma a,⁎, Suresh Verma a, Usha Justa a, Pawan K. Soni b, Ashok Verma a
5 6
a
7
a r t i c l e
8 9 10 11
Article history: Received 30 July 2014 Received in revised form 28 October 2014 Accepted 22 December 2014
12 13 14 15 16 17 18
Keywords: Cesarean Pregnancy Scar dehiscence Scar rupture Trial of labor after cesarean Vaginal birth after cesarean
i n f o
R O
Department of Obstetrics and Gynecology, Dr. Rajendra Prasad Government Medical College, Kangra, India Department of Radio-diagnosis, Dr. Rajendra Prasad Government Medical College, Kangra, India
a b s t r a c t
E
D
P
Objective: To determine the success rate of trial of labor after cesarean (TOLAC) in rural India. Methods: The present prospective observational study enrolled pregnant women attending Dr Rajendra Prasad Government Medical College, Kangra, India, in 2013. Eligible women had a previous low-segment cesarean delivery and had a singleton pregnancy with cephalic presentation. Women in labor were managed as per the institutional protocol. Results: In total, 482 women were included. TOLAC led to a vaginal delivery in 383 (79.6%) women. Overall, 2 (0.4%) women had scar rupture, and 4 (0.8%) had scar dehiscence. Fetal death was recorded in one woman with scar rupture, for whom peripartum hysterectomy was necessary. Blood loss was significantly lower among the 316 women with normal vaginal delivery than among the 99 who underwent cesarean (P b 0.001). Blood transfusion was required in 2 (0.6%) women with normal vaginal delivery and 2 (2.0%) with cesarean delivery (P = 0.05). The proportion of neonates who had to be admitted to intensive care did not differ significantly by mode of delivery (P = 0.06). Conclusion: Under strict supervision, TOLAC is a reasonable option even in rural India. © 2014 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
35 33 32
E
34
1. Introduction
37 38
The rates of cesarean delivery are increasing worldwide [1]. As a result, the numbers of pregnant women who have previously had a cesarean are also rising, placing a substantial burden on the constrained resources of low-income countries. Both attending obstetricians and pregnant women are then faced with the dilemma of whether to opt for an elective repeat cesarean or to undergo trial of labor after cesarean (TOLAC), which could lead to cesarean scar rupture. The US National Institutes of Health has examined the safety and outcome of TOLAC, recognizing that “it is a reasonable option for many women with a previous cesarean” and calling on organizations to improve access [2]. The American College of Obstetricians and Gynecologists (ACOG) also suggests that most women who have had one previous low-segment cesarean should be offered TOLAC [3]. Contrary to the guidelines [2,3], however, the rates of TOLAC are decreasing worldwide [4]. Women’s preferences, fear of liability on the part of the care provider in high-income countries [3], and a lack of adequate facilities in low-income countries (e.g. no immediately available emergency cesarean facilities or continuous electronic fetal monitoring) [1,3] are leading to an alarming rise in the rate of cesarean delivery to epidemic levels.
45 46 47 48 49 50 51 52 53 54 55 56
R
N C O
43 44
U
41 42
R
36
39 40
19 20 21 22 23 24 25 26 27 28 29 30 31
C
T
b
O
F
3
A prospective observational study of trial of labor after cesarean in rural India
2Q2
⁎ Corresponding author at: Set No. 112, Vivekanand Hostel, Dr RPGMC, Kangra HP, 176001, India. Tel.: +91 9218925471; fax: +91 1892 287187. E-mail address: [email protected] (C. Sharma).
Studies in low-income countries portray a grim picture of TOLAC, with success rates ranging from 28% to 60% [1,5–8]. These low rates, coupled with the associated increased maternal morbidity among women undergoing emergency cesarean after failed TOLAC [2], could encourage women to plan an elective repeat cesarean delivery rather than to undergo a trial of labor that ultimately results in an emergency procedure. The aim of the present study was to assess the success rate of TOLAC in a rural teaching hospital in India.
57 58
2. Materials and methods
65
The present prospective observational study was conducted from January 1 to December 31, 2013, among pregnant women who had a previous cesarean delivery, were eligible for TOLAC, and attended Dr Rajendra Prasad Government Medical College and Hospital, Kangra, Himachal Pradesh, India. This center is a tertiary-care teaching hospital catering to the needs of the adjoining rural and tribal population, with an annual average of 8000 deliveries, of which 2000 are cesareans. The inclusion criteria were one previous low-segment cesarean delivery and a singleton pregnancy with cephalic presentation. Several exclusion criteria were used: a classic cesarean, T-shaped, or J- shaped uterine incision; previous uterine surgery (myomectomy or hysterotomy); intrauterine fetal death (IUFD); a congenitally malformed fetus; early conception (interdelivery interval b 18 months); preterm labor (b 37 weeks); cephalopelvic disproportion; placenta previa; associated medical or surgical complications; or any indication precluding TOLAC.
66
http://dx.doi.org/10.1016/j.ijgo.2014.11.007 0020-7292/© 2014 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
59 60 61 62 63 64
67 68 69 70 71 72 73 74 75 76 77 78 79 80
106 107 108 109
113 114 115 116 117
C
104 105
E
102 103
R
100 101
R
98 99
O
96 97
Women presenting with previous cesarean (n=2186) Women excluded (n=1704) Two previous cesareans (n=388) Declined to participate (n=213) Previous uterine scar extension/unknown uterine scar (n=517) Elective cesarean for obstetric indication (n=586)
C
94 95
N
92 93
U
90 91
F
During the study period there were 7444 deliveries, among which 2186 (29.4%) women had a previous cesarean delivery. Of these, 388 women had two previous cesareans, 517 had either extension of the uterine incision or no record of the previous uterine incision, and 213 women refused to undergo TOLAC. In addition, 586 women had an obstetric or recurrent indication in the current pregnancy and an elective
88 89
O
112
87
R O
3. Results
85 86
P
111
83 84
repeat cesarean delivery was planned. As a result, 482 women were selected for TOLAC (Fig. 1). Among the 482 women eligible for TOLAC, 383 (79.6%) had vaginal delivery (316 [65.6%] with NVD; 67 [14.0%] with OVD) and 99 (20.4%) had emergency cesarean delivery. Hence, the success rate of TOLAC was 79.6%. Age, body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters), gravidity (parity or abortions), and interpregnancy interval did not differ significantly among the groups (Table 1). However, the proportion of women who underwent their previous cesarean because of induction failure or non-progress of labor did differ significantly (P = 0.014 and P = 0.010, respectively) (Table 1). Additionally, duration of both the first and second stages of labor were significantly longer among women with OVD than among those with NVD (P b 0.001 for both) (Table 1). Maternal and neonatal complications of the participants are summarized in Table 2. Scar rupture occurred in 2 (0.4%) women. One of these women presented at the labor room late in the second stage with IUFD, and had a vaginal delivery of a stillborn fetus. Subsequently, she had postpartum hemorrhage and omentum was seen protruding through the vagina. She underwent emergency laparotomy and had a peripartum hysterectomy owing to severe hemorrhage and irreparable uterine tears. Among the remaining participants who underwent TOLAC under close observation in the labor room, four had scar dehiscence. These four women and the other with scar rupture underwent emergency cesarean delivery with good neonatal outcome. Significantly fewer women with vaginal delivery (NVD and OVD) than in the cesarean group had blood loss of 500–1000 mL (P b 0.001) or more than 1000 mL (P = 0.001) (Table 2). The proportion who required blood transfusion was lower in women who delivered vaginally (NVD and OVD) than in the cesarean group, but the difference was not significant (P = 0.05) (Table 2). Admission to the neonatal intensive care unit did not differ significantly between the study groups (P = 0.06) (Table 2). Spontaneous labor occurred significantly more frequently in the NVD group than in the OVD or cesarean groups (P = 0.001) (Table 3). Induction of labor (with oxytocin) was associated with a significantly higher incidence of cesarean delivery (P b 0.001) (Table 3). However, augmentation of labor did not differ significantly among the three groups (P = 0.269) (Table 3). The Bishop score was
T
110
Those who refused TOLAC were also excluded. The study was approved by the Institutional Ethics Committee (registration no. ECR/490/Inst/HP/ 2013) and registered with the Clinical Trials Registry of India (REF/14/ 07/007292). All women gave informed consent for TOLAC. All women were examined in detail by a senior consultant at completion of 37 weeks of pregnancy. Records of previous surgery were reviewed and a pelvic assessment was done. All women in labor were managed as per institutional protocol. Labor, whether spontaneous or induced, was monitored with continuous electronic fetal heart monitoring in accordance with ACOG guidelines [3]. When required, labor was augmented with oxytocin (Oxytomed; 5 IU; German Remedies, Gurgaon, India). The need for emergency cesarean delivery was determined by the team of managing obstetricians. Neonates were managed as per the attending neonatologist’s opinion. After vaginal delivery, exploration of the previous cesarean scar was not done manually because there is no clear benefit to the patient and there is a risk of converting scar dehiscence into scar rupture [9]. Scar rupture was defined as a breach in all layers of the uterine wall (including serosa); scar dehiscence was defined as a breach in all except the serosal layer of the uterus. Participants were divided into three groups for analysis: normal vaginal delivery (NVD), operative vaginal delivery (OVD), or cesarean delivery. Data were entered into SPSS version 17 (SPSS Inc, Chicago, IL, USA). Statistical analysis was performed on the basis of intention to deliver. Data are reported as mean ± SD, median (interquartile range), or number (percentage). Parametric and non-parametric tests were used as appropriate. The normality of the distribution was assessed by the Kolmogorov−Smirnov test. Continuous data were analyzed by the t test (normal distribution) and Mann−Whitney U test (non-normal distribution); categorical variables were analyzed by Fisher exact test. P value b 0.05 was considered statistically significant.
D
81 82
A. Soni et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx
E
2
Women eligible for TOLAC (n=482)
Normal vaginal delivery (n=316)
Operative vaginal delivery (n=67)
Cesarean delivery (n=99)
Fig. 1. Selection and flow of participants through the study.
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157
A. Soni et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx t1:1 t1:2
3
Table 1 Demographic characteristics of women in study.a P valueb
Characteristic
Normal vaginal delivery (n = 316)
Operative vaginal delivery (n = 67)
Cesarean delivery (n = 99)
t1:4 t1:5 t1:6 t1:7 t1:8 t1:9 t1:10 t1:11 t1:12 t1:13 t1:14 t1:15 t1:16 t1:17 t1:18 t1:19 t1:20 t1:21
Age, y BMI Gravida Parous One previous spontaneous abortion Two previous spontaneous abortions Indication for previous cesarean Fetal distress Malpresentation Failure of induction Non-progress of labor Interpregnancy interval, mo 18–24 24–36 N36 Duration of labor, minc First stage Second stage
27 (25–29) 21 (20.2–21.9)
27 (25–30) 21 (20.2–21.6)
27 (25–29) 21 (20.3–21.6)
0.621 0.719
215 (68.0) 62 (19.6) 9 (2.8)
49 (73.1) 14 (20.9) 1 (1.5)
71 (71.7) 20 (20.2) 3 (3.0)
0.617 0.975 0.863
154 (48.7) 92 (29.1) 25 (7.9) 44 (13.9)
30 (44.8) 12 (17.9) 7 (10.4) 19 (28.3)
42 (42.4) 21 (21.2) 15 (15.1) 21 (21.2)
0.511 0.081 0.014 0.010
33 (10.4) 98 (31.0) 185 (58.5)
8 (11.9) 19 (28.3) 40 (59.7)
8 (8.1) 27 (27.3) 64 (64.6)
0.695 0.745 0.557
356 ± 162 25 (20–29)
413 ± 172 29 (20–35)
O
F
t1:3
Abbreviation: BMI (body mass index, calculated as weight in kilograms divided by the square of height in meters). a Values are given as median (interquartile range), number (percentage), or mean ± SD, unless indicated otherwise. b For comparison of all three groups. c Duration of stages cannot be calculated for cesarean group.
158
significantly higher in the NVD and OVD groups than in the cesarean group (P b 0.001) (Table 3). Period of gestation at delivery was significantly lower for women with NVD (P = 0.009) (Table 3). When these three groups were further categorized with respect to a period of gestation of more than 280 days, the difference was not significant (P = 0.098) (Table 3). Birth weight of the previous neonate did not differ significantly among the study groups (P = 0.130) (Table 3). However, women with cesarean or OVD had heavier fetuses than did those in the NVD group (P = 0.010) (Table 3). There was no difference in the number of current neonates with a birth weight that was 500 g or more higher than the previous birth weight (P = 0.915) (Table 3). Previous vaginal delivery and successful vaginal birth after cesarean did not differ significantly among three groups (P = 0.071 and P = 0.81, respectively) (Table 3). The interpregnancy interval was not significantly statistically different among the three groups (Table 3). The indication for previous CS was acute fetal distress (AFD) for 226 (46.9%) women, non-progress of labor (NPL) for 84 (17.4%), failure of induction for 47 (9.8%), and malpresentation for 125 (25.9%) (Fig. 2). The incidence of successful vaginal delivery in the current pregnancy was 83.2% (104/125) among women with malpresentation as the indication for previous cesarean, 81.4% (184/226) for women with AFD,
171 172 173 174 175 176 177 178 179
t2:1 t2:2 t2:3 t2:4
t2:5 t2:6 t2:7 t2:8 t2:9 t2:10 t2:11 t2:12 t2:13 t2:14 t2:15 t2:16 t2:17 t2:18
Table 2 Maternal and fetal complications according to mode of delivery.a Specific complication
Maternal Scar dehiscence Scar rupture Hysterectomy Blood loss, mL 500–1000 N1000 Blood transfusion Fetal Neonatal ICU admission IUFD/early neonatal death
Normal vaginal delivery (n = 316)
Operative vaginal delivery (n = 67)
Cesarean delivery (n = 99)
P valueb
0 1 (0.3) 1 (0.3)
0 0 0
4 (4.0) 1 (1.0) 0
b0.001 0.548 0.769
1 (0.3) 1 (0.3) 2 (0.6)
0 2 (2.9) 3 (4.4)
93 (93.9) 5 (5.1) 2 (2.0)
b0.001 0.001 0.05
4 (1.2) 1 (0.3)
2 (2.9) 0
6 (6.1) 0
Abbreviations: ICU, intensive care unit; IUFD, intrauterine fetal death. a Values are given as number (percentage) unless indicated otherwise. b For comparison of all three groups.
0.06 0.769
180
4. Discussion
188
In the present study, approximately one-third of all women who presented at the labor room in the study period had a previous cesarean delivery. The present results demonstrate that, with careful selection of candidates, successful TOLAC can reach a reasonably acceptable level (79.6%) even in a rural area of a low-income country. A success rate of TOLAC of 60%–80% has been reported in highresource countries [3]. By contrast, most studies from low-income countries have shown a much lower success rate of TOLAC, ranging from as low as 28% to 60% [1,5–7]. Various reasons for this low rate have been hypothesized—e.g. late access to health care after already established labor, poor educational status, indication for previous cesarean not known, and poor record keeping of previous cesarean delivery [1,5–7]. In the present study, few women had scar rupture (0.4%). One occurred in a woman who presented late in the second stage of labor with IUFD; scar rupture was identified in the postpartum period. Among the remaining women who were selected for TOLAC, therefore, there was one scar rupture and four cases of scar dehiscence, all with optimal neonatal outcome. This is in sharp contrast to studies in lowresource countries, where the incidence of scar rupture reportedly ranges from 1.3% [1] to 4.2% [8]. The high success rate in the present study might be due to appropriate selection of women, and intensive intrapartum monitoring with early recognition of the catastrophic events of scar dehiscence or rupture. A major limitation of the study is that a substantial number of women were not enrolled for TOLAC, owing to a history of previous uterine scar extension or unknown nature of the scar (n = 517), in accordance with the study protocol. Such exclusion might have confounded the high success rate of TOLAC (79.6%) observed in the study. In our opinion, however, this further signifies that careful selection of women for TOLAC is essential to have a favorable outcome (i.e. vaginal delivery)
189
D
75.0% (63/84) for women with NPL, and 68.0% (32/47) for women with failure of induction. Among 226 women with previous cesarean for AFD, 24 (10.6%) had a repeat cesarean for the same indication. Similarly, 11 (13.1%) of 84 had a repeat cesarean for NPL, and 5 (10.6%) of 47 had a repeat cesarean for failure of induction. Because women with malpresentation in the current pregnancy were excluded from the study, the percentage of women who required repeat cesarean for this indication could not be estimated.
E
T
C
E
169 170
R
167 168
R
165 166
N C O
163 164
U
161 162
P
t1:22 t1:23 t1:24 t1:25
159 160
b0.001 b0.001
R O
– –
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
181 182 183 184 185 186 187
190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218
4
Table 3 Relationship of various predictive factors with mode of delivery.a
t3:4 t3:5 t3:6 t3:7 t3:8 t3:9 t3:10 t3:11 t3:12 t3:13 t3:14 t3:15 t3:16 t3:17 t3:18 t3:19 t3:20
Mode of onset of labor Spontaneous labor Induced labor Augmentation of labor Bishop score POG at delivery, d POG N280 d Birth weight, kg Previous Present Present N500 g more than previous Previous vaginal delivery Previous successful TOLAC Inter-pregnancy interval, mo 18–24 24–36 N36
Normal vaginal delivery (n = 316)
Operative vaginal delivery (n = 67)
Cesarean delivery (n = 99)
P valueb
264 (83.5) 14 (4.4) 38 (12.0) 7 (6–8) 274 (269–279) 74 (23.4)
54 (80.6) – 13 (19.4) 7 (6–9) 277 (273–281) 22 (32.8)
65 (65.6) 20 (20.2) 14 (14.1) 6 (5–8) 275 (272–281) 32 (32.3)
0.001 b0.001 0.269 b0.001 0.009 0.098
2.7 (2.5–3.0) 2.7 (2.5–3.0) 92 (29.1) 33 (10.4) 17 (5.4) 33 (10.4) 98 (31.1) 185 (58.5)
2.7 (2.5–3) 3.0 (2.7–3.2) 22 (32.8) 2 (3.0) 1 (1.5)
2.7 (2.5–3.0) 2.8 (2.5–3.0) 35 (35.3) 6 (6.1) 1 (1)
0.130 0.010 0.915 0.071 0.081
8 (11.9) 19 (28.3) 40 (59.7)
8 (8.1) 27 (27.3) 64 (64.6)
0.695 0.745 0.557
t3:21 t3:22 t3:23
Abbreviations: POG, period of gestation; TOLAC, trial of labor after cesarean. a Values are given as number (percentage) or median (interquartile range), unless indicated otherwise. b For comparison of all three groups.
219
and to prevent catastrophic outcomes (e.g. scar rupture, peripartum hysterectomy, and fetal death). Spontaneous onset of labor, favorable Bishop score, and birth weight were significantly associated with the incidence of successful TOLAC in the present study; these results are comparable with previous data [1, 3,10]. However, a current birth weight of 500 g or more higher than the previous birth weight was not found to affect the incidence of successful TOLAC. Previous vaginal delivery, previous successful TOLAC, interdelivery interval, and a period of gestation of more than 40 weeks did not differ significantly among the three study groups. Prior vaginal birth and specifically prior successful TOLAC (i.e. vaginal birth after CS) have been observed to be very strong predictors of successful TOLAC [11–17]. The present observation is thus contrary to previous evidence, probably owing to the low number of women in these subgroups in the present study (n = 49 and n = 19, respectively). Evidence in favor of interdelivery interval [18] and a period of gestation of more than 40 weeks is controversial, with some studies indicating [19,20] and some negating [21] any benefit of these variables. Women with cesarean after TOLAC had a significantly higher incidence of maternal complications in terms of scar dehiscence and blood loss in the present study. Admission to the neonatal intensive
234 235 236 237 238 239 240
259
E
D
P
Conflict of interest
T
C
E
232 233
R
230 231
R
228 229
O
226 227
The authors have no conflicts of interest.
C
224 225
241
N
222 223
care unit also approached statistical significance, with a higher occurrence among women with cesarean after TOLAC. This observation is in accordance with previous studies in which failed TOLAC was associated with worse maternal and fetal outcomes as compared with successful TOLAC [22–25]. In summary, under intensive labor monitoring and with appropriate selection of women, trial of labor among women with previous cesarean has been shown to be a reasonable option, even in a rural area of a lowresource country with limited facilities. However, TOLAC can be risky in small centers lacking the continuous availability of intensive electronic labor monitoring and facilities for operative delivery. Scar dehiscence and/or rupture—although rare in the present study—are unpredictable and catastrophic in terms of maternal and neonatal outcomes, and no predictive factor has been shown to be consistently associated with a successful outcome of TOLAC. Nevertheless, it might not be justifiable to carry out such a high number of cesarean procedures, especially in rural areas of low-resource countries with limited resources, to prevent one scar rupture or fetal death.
U
220 221
F
Specific predictive factor
O
t3:3
R O
t3:1 t3:2
A. Soni et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx
Fig. 2. Relationship between successful TOLAC and indication for previous cesarean delivery. Abbreviations: TOLAC, trial of labor after cesarean; AFD; acute fetal distress; NPL, non-progress of labor; FoI, failure of induction; MP, malpresentation; RI, repeat cesarean because of similar indication; CS, cesarean; VD, vaginal delivery.
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258
260
A. Soni et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx
F
O
R O
[1] Madaan M, Agrawal S, Nigam A, Aggarwal R, Trivedi SS. Trial of labour after previous caesarean section: the predictive factors affecting outcome. J Obstet Gynaecol 2011; 31(3):224–8. [2] National Institutes of Health Consensus Development Conference Panel. National Institutes of Health Consensus Development conference statement: vaginal birth after cesarean: new insights March 8-10, 2010. Obstet Gynecol 2010;115(6): 1279–95. [3] American College of Obstetricians and Gynecologists. ACOG Practice bulletin no. 115: Vaginal birth after previous cesarean delivery. Obstet Gynecol 2010;116(2 Pt 1): 450–63. [4] Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S, et al. Births: final data for 2005. Natl Vital Stat Rep 2007;56(6):1–103. [5] Gupta S, Jeeyaselan S, Guleria R, Gupta A. An observational study of various predictors of success of vaginal delivery following a previous cesarean section. J Obstet Gynaecol India 2014;64(4):260–4. [6] Balachandran L, Vaswani PR, Mogotlane R. Pregnancy outcome in women with previous one cesarean section. J Clin Diagn Res 2014;8(2):99–102. [7] Agarwal A, Chowdhary P, Das V, Srivastava A, Pandey A, Sahu MT. Evaluation of pregnant women with scarred uterus in a low resource setting. J Obstet Gynaecol Res 2007;33(5):651–4. [8] George A, Arasi KV, Mathai M. Is vaginal birth after cesarean delivery a safe option in India? Int J Gynecol Obstet 2004;85(1):42–3. [9] Jerbi M, Hidar S, Zardi H, Chaieb A, Khairi H. Previous cesarean scar exploration following vaginal delivery and hemorrhagic morbidity. Int J Gynecol Obstet 2006; 92(2):135–6. [10] 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(5):1644–8. [11] Mercer BM, Gilbert S, Landon MB, Spong CY, Leveno KJ, Rouse DJ, et al. Labor outcomes with increasing number of prior vaginal births after cesarean delivery. Obstet Gynecol 2008;111(2 Pt 1):285–91. [12] 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(3 Pt 2):1016–23.
P
262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 331
[13] Cahill AG, Stamilio DM, Odibo AO, Peipert JF, Ratcliffe SJ, Stevens EJ, et al. Is vaginal birth after cesarean (VBAC) or elective repeat cesarean safer in women with a prior vaginal delivery? Am J Obstet Gynecol 2006;195(4):1143–7. [14] McNally OM, Turner MJ. Induction of labour after 1 previous Caesarean section. Aust N Z J Obstet Gynaecol 1999;39(4):425–9. [15] Macones GA, Hausman N, Edelstein R, Stamilio DM, Marder SJ. Predicting outcomes of trials of labor in women attempting vaginal birth after cesarean delivery: a comparison of multivariate methods with neural networks. Am J Obstet Gynecol 2001; 184(3):409–13. [16] Weinstein D, Benshushan A, Tanos V, Zilberstein R, Rojansky N. Predictive score for vaginal birth after cesarean section. Am J Obstet Gynecol 1996;174(1 Pt 1):192–8. [17] Flamm BL, Geiger AM. Vaginal birth after cesarean delivery: an admission scoring system. Obstet Gynecol 1997;90(6):907–10. [18] Huang WH, Nakashima DK, Rumney PJ, Keegan Jr KA, Chan K. Interdelivery interval and the success of vaginal birth after cesarean delivery. Obstet Gynecol 2002;99(1): 41–4. [19] Yeh S, Huang X, Phelan JP. Postterm pregnancy after previous cesarean section. J Reprod Med 1984;29(1):41–4. [20] Kiran TS, Chui YK, Bethel J, Bhal PS. Is gestational age an independent variable affecting uterine scar rupture rates? Eur J Obstet Gynecol Reprod Biol 2006;126(1): 68–71. [21] Coassolo KM, Stamilio DM, Paré E, Peipert JF, Stevens E, Nelson DB, et al. Safety and efficacy of vaginal birth after cesarean attempts at or beyond 40 weeks of gestation. Obstet Gynecol 2005;106(4):700–6. [22] 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(25):2581–9. [23] Macones GA, Peipert J, Nelson DB, Odibo A, Stevens EJ, Stamilio DM, et al. Maternal complications with vaginal birth after cesarean delivery: a multicenter study. Am J Obstet Gynecol 2005;193(5):1656–62. [24] Flamm BL, Newman LA, Thomas SJ, Fallon D, Yoshida MM. Vaginal birth after cesarean delivery: results of a 5-year multicenter collaborative study. Obstet Gynecol 1990;76(5 Pt 1):750–4. [25] McMahon MJ, Luther ER, Bowes Jr WA, Olshan AF. Comparison of a trial of labor with an elective second cesarean section. N Engl J Med 1996;335(10):689–95.
D
References
U
N C O
R
R
E
C
T
E
261
5
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
1
CLINICAL ARTICLE
4Q1
Anjali Soni a, Chanderdeep Sharma a,⁎, Suresh Verma a, Usha Justa a, Pawan K. Soni b, Ashok Verma a
5 6
a
7
a r t i c l e
8 9 10 11
Article history: Received 30 July 2014 Received in revised form 28 October 2014 Accepted 22 December 2014
12 13 14 15 16 17 18
Keywords: Cesarean Pregnancy Scar dehiscence Scar rupture Trial of labor after cesarean Vaginal birth after cesarean
i n f o
R O
Department of Obstetrics and Gynecology, Dr. Rajendra Prasad Government Medical College, Kangra, India Department of Radio-diagnosis, Dr. Rajendra Prasad Government Medical College, Kangra, India
a b s t r a c t
E
D
P
Objective: To determine the success rate of trial of labor after cesarean (TOLAC) in rural India. Methods: The present prospective observational study enrolled pregnant women attending Dr Rajendra Prasad Government Medical College, Kangra, India, in 2013. Eligible women had a previous low-segment cesarean delivery and had a singleton pregnancy with cephalic presentation. Women in labor were managed as per the institutional protocol. Results: In total, 482 women were included. TOLAC led to a vaginal delivery in 383 (79.6%) women. Overall, 2 (0.4%) women had scar rupture, and 4 (0.8%) had scar dehiscence. Fetal death was recorded in one woman with scar rupture, for whom peripartum hysterectomy was necessary. Blood loss was significantly lower among the 316 women with normal vaginal delivery than among the 99 who underwent cesarean (P b 0.001). Blood transfusion was required in 2 (0.6%) women with normal vaginal delivery and 2 (2.0%) with cesarean delivery (P = 0.05). The proportion of neonates who had to be admitted to intensive care did not differ significantly by mode of delivery (P = 0.06). Conclusion: Under strict supervision, TOLAC is a reasonable option even in rural India. © 2014 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
35 33 32
E
34
1. Introduction
37 38
The rates of cesarean delivery are increasing worldwide [1]. As a result, the numbers of pregnant women who have previously had a cesarean are also rising, placing a substantial burden on the constrained resources of low-income countries. Both attending obstetricians and pregnant women are then faced with the dilemma of whether to opt for an elective repeat cesarean or to undergo trial of labor after cesarean (TOLAC), which could lead to cesarean scar rupture. The US National Institutes of Health has examined the safety and outcome of TOLAC, recognizing that “it is a reasonable option for many women with a previous cesarean” and calling on organizations to improve access [2]. The American College of Obstetricians and Gynecologists (ACOG) also suggests that most women who have had one previous low-segment cesarean should be offered TOLAC [3]. Contrary to the guidelines [2,3], however, the rates of TOLAC are decreasing worldwide [4]. Women’s preferences, fear of liability on the part of the care provider in high-income countries [3], and a lack of adequate facilities in low-income countries (e.g. no immediately available emergency cesarean facilities or continuous electronic fetal monitoring) [1,3] are leading to an alarming rise in the rate of cesarean delivery to epidemic levels.
45 46 47 48 49 50 51 52 53 54 55 56
R
N C O
43 44
U
41 42
R
36
39 40
19 20 21 22 23 24 25 26 27 28 29 30 31
C
T
b
O
F
3
A prospective observational study of trial of labor after cesarean in rural India
2Q2
⁎ Corresponding author at: Set No. 112, Vivekanand Hostel, Dr RPGMC, Kangra HP, 176001, India. Tel.: +91 9218925471; fax: +91 1892 287187. E-mail address: [email protected] (C. Sharma).
Studies in low-income countries portray a grim picture of TOLAC, with success rates ranging from 28% to 60% [1,5–8]. These low rates, coupled with the associated increased maternal morbidity among women undergoing emergency cesarean after failed TOLAC [2], could encourage women to plan an elective repeat cesarean delivery rather than to undergo a trial of labor that ultimately results in an emergency procedure. The aim of the present study was to assess the success rate of TOLAC in a rural teaching hospital in India.
57 58
2. Materials and methods
65
The present prospective observational study was conducted from January 1 to December 31, 2013, among pregnant women who had a previous cesarean delivery, were eligible for TOLAC, and attended Dr Rajendra Prasad Government Medical College and Hospital, Kangra, Himachal Pradesh, India. This center is a tertiary-care teaching hospital catering to the needs of the adjoining rural and tribal population, with an annual average of 8000 deliveries, of which 2000 are cesareans. The inclusion criteria were one previous low-segment cesarean delivery and a singleton pregnancy with cephalic presentation. Several exclusion criteria were used: a classic cesarean, T-shaped, or J- shaped uterine incision; previous uterine surgery (myomectomy or hysterotomy); intrauterine fetal death (IUFD); a congenitally malformed fetus; early conception (interdelivery interval b 18 months); preterm labor (b 37 weeks); cephalopelvic disproportion; placenta previa; associated medical or surgical complications; or any indication precluding TOLAC.
66
http://dx.doi.org/10.1016/j.ijgo.2014.11.007 0020-7292/© 2014 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
59 60 61 62 63 64
67 68 69 70 71 72 73 74 75 76 77 78 79 80
106 107 108 109
113 114 115 116 117
C
104 105
E
102 103
R
100 101
R
98 99
O
96 97
Women presenting with previous cesarean (n=2186) Women excluded (n=1704) Two previous cesareans (n=388) Declined to participate (n=213) Previous uterine scar extension/unknown uterine scar (n=517) Elective cesarean for obstetric indication (n=586)
C
94 95
N
92 93
U
90 91
F
During the study period there were 7444 deliveries, among which 2186 (29.4%) women had a previous cesarean delivery. Of these, 388 women had two previous cesareans, 517 had either extension of the uterine incision or no record of the previous uterine incision, and 213 women refused to undergo TOLAC. In addition, 586 women had an obstetric or recurrent indication in the current pregnancy and an elective
88 89
O
112
87
R O
3. Results
85 86
P
111
83 84
repeat cesarean delivery was planned. As a result, 482 women were selected for TOLAC (Fig. 1). Among the 482 women eligible for TOLAC, 383 (79.6%) had vaginal delivery (316 [65.6%] with NVD; 67 [14.0%] with OVD) and 99 (20.4%) had emergency cesarean delivery. Hence, the success rate of TOLAC was 79.6%. Age, body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters), gravidity (parity or abortions), and interpregnancy interval did not differ significantly among the groups (Table 1). However, the proportion of women who underwent their previous cesarean because of induction failure or non-progress of labor did differ significantly (P = 0.014 and P = 0.010, respectively) (Table 1). Additionally, duration of both the first and second stages of labor were significantly longer among women with OVD than among those with NVD (P b 0.001 for both) (Table 1). Maternal and neonatal complications of the participants are summarized in Table 2. Scar rupture occurred in 2 (0.4%) women. One of these women presented at the labor room late in the second stage with IUFD, and had a vaginal delivery of a stillborn fetus. Subsequently, she had postpartum hemorrhage and omentum was seen protruding through the vagina. She underwent emergency laparotomy and had a peripartum hysterectomy owing to severe hemorrhage and irreparable uterine tears. Among the remaining participants who underwent TOLAC under close observation in the labor room, four had scar dehiscence. These four women and the other with scar rupture underwent emergency cesarean delivery with good neonatal outcome. Significantly fewer women with vaginal delivery (NVD and OVD) than in the cesarean group had blood loss of 500–1000 mL (P b 0.001) or more than 1000 mL (P = 0.001) (Table 2). The proportion who required blood transfusion was lower in women who delivered vaginally (NVD and OVD) than in the cesarean group, but the difference was not significant (P = 0.05) (Table 2). Admission to the neonatal intensive care unit did not differ significantly between the study groups (P = 0.06) (Table 2). Spontaneous labor occurred significantly more frequently in the NVD group than in the OVD or cesarean groups (P = 0.001) (Table 3). Induction of labor (with oxytocin) was associated with a significantly higher incidence of cesarean delivery (P b 0.001) (Table 3). However, augmentation of labor did not differ significantly among the three groups (P = 0.269) (Table 3). The Bishop score was
T
110
Those who refused TOLAC were also excluded. The study was approved by the Institutional Ethics Committee (registration no. ECR/490/Inst/HP/ 2013) and registered with the Clinical Trials Registry of India (REF/14/ 07/007292). All women gave informed consent for TOLAC. All women were examined in detail by a senior consultant at completion of 37 weeks of pregnancy. Records of previous surgery were reviewed and a pelvic assessment was done. All women in labor were managed as per institutional protocol. Labor, whether spontaneous or induced, was monitored with continuous electronic fetal heart monitoring in accordance with ACOG guidelines [3]. When required, labor was augmented with oxytocin (Oxytomed; 5 IU; German Remedies, Gurgaon, India). The need for emergency cesarean delivery was determined by the team of managing obstetricians. Neonates were managed as per the attending neonatologist’s opinion. After vaginal delivery, exploration of the previous cesarean scar was not done manually because there is no clear benefit to the patient and there is a risk of converting scar dehiscence into scar rupture [9]. Scar rupture was defined as a breach in all layers of the uterine wall (including serosa); scar dehiscence was defined as a breach in all except the serosal layer of the uterus. Participants were divided into three groups for analysis: normal vaginal delivery (NVD), operative vaginal delivery (OVD), or cesarean delivery. Data were entered into SPSS version 17 (SPSS Inc, Chicago, IL, USA). Statistical analysis was performed on the basis of intention to deliver. Data are reported as mean ± SD, median (interquartile range), or number (percentage). Parametric and non-parametric tests were used as appropriate. The normality of the distribution was assessed by the Kolmogorov−Smirnov test. Continuous data were analyzed by the t test (normal distribution) and Mann−Whitney U test (non-normal distribution); categorical variables were analyzed by Fisher exact test. P value b 0.05 was considered statistically significant.
D
81 82
A. Soni et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx
E
2
Women eligible for TOLAC (n=482)
Normal vaginal delivery (n=316)
Operative vaginal delivery (n=67)
Cesarean delivery (n=99)
Fig. 1. Selection and flow of participants through the study.
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157
A. Soni et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx t1:1 t1:2
3
Table 1 Demographic characteristics of women in study.a P valueb
Characteristic
Normal vaginal delivery (n = 316)
Operative vaginal delivery (n = 67)
Cesarean delivery (n = 99)
t1:4 t1:5 t1:6 t1:7 t1:8 t1:9 t1:10 t1:11 t1:12 t1:13 t1:14 t1:15 t1:16 t1:17 t1:18 t1:19 t1:20 t1:21
Age, y BMI Gravida Parous One previous spontaneous abortion Two previous spontaneous abortions Indication for previous cesarean Fetal distress Malpresentation Failure of induction Non-progress of labor Interpregnancy interval, mo 18–24 24–36 N36 Duration of labor, minc First stage Second stage
27 (25–29) 21 (20.2–21.9)
27 (25–30) 21 (20.2–21.6)
27 (25–29) 21 (20.3–21.6)
0.621 0.719
215 (68.0) 62 (19.6) 9 (2.8)
49 (73.1) 14 (20.9) 1 (1.5)
71 (71.7) 20 (20.2) 3 (3.0)
0.617 0.975 0.863
154 (48.7) 92 (29.1) 25 (7.9) 44 (13.9)
30 (44.8) 12 (17.9) 7 (10.4) 19 (28.3)
42 (42.4) 21 (21.2) 15 (15.1) 21 (21.2)
0.511 0.081 0.014 0.010
33 (10.4) 98 (31.0) 185 (58.5)
8 (11.9) 19 (28.3) 40 (59.7)
8 (8.1) 27 (27.3) 64 (64.6)
0.695 0.745 0.557
356 ± 162 25 (20–29)
413 ± 172 29 (20–35)
O
F
t1:3
Abbreviation: BMI (body mass index, calculated as weight in kilograms divided by the square of height in meters). a Values are given as median (interquartile range), number (percentage), or mean ± SD, unless indicated otherwise. b For comparison of all three groups. c Duration of stages cannot be calculated for cesarean group.
158
significantly higher in the NVD and OVD groups than in the cesarean group (P b 0.001) (Table 3). Period of gestation at delivery was significantly lower for women with NVD (P = 0.009) (Table 3). When these three groups were further categorized with respect to a period of gestation of more than 280 days, the difference was not significant (P = 0.098) (Table 3). Birth weight of the previous neonate did not differ significantly among the study groups (P = 0.130) (Table 3). However, women with cesarean or OVD had heavier fetuses than did those in the NVD group (P = 0.010) (Table 3). There was no difference in the number of current neonates with a birth weight that was 500 g or more higher than the previous birth weight (P = 0.915) (Table 3). Previous vaginal delivery and successful vaginal birth after cesarean did not differ significantly among three groups (P = 0.071 and P = 0.81, respectively) (Table 3). The interpregnancy interval was not significantly statistically different among the three groups (Table 3). The indication for previous CS was acute fetal distress (AFD) for 226 (46.9%) women, non-progress of labor (NPL) for 84 (17.4%), failure of induction for 47 (9.8%), and malpresentation for 125 (25.9%) (Fig. 2). The incidence of successful vaginal delivery in the current pregnancy was 83.2% (104/125) among women with malpresentation as the indication for previous cesarean, 81.4% (184/226) for women with AFD,
171 172 173 174 175 176 177 178 179
t2:1 t2:2 t2:3 t2:4
t2:5 t2:6 t2:7 t2:8 t2:9 t2:10 t2:11 t2:12 t2:13 t2:14 t2:15 t2:16 t2:17 t2:18
Table 2 Maternal and fetal complications according to mode of delivery.a Specific complication
Maternal Scar dehiscence Scar rupture Hysterectomy Blood loss, mL 500–1000 N1000 Blood transfusion Fetal Neonatal ICU admission IUFD/early neonatal death
Normal vaginal delivery (n = 316)
Operative vaginal delivery (n = 67)
Cesarean delivery (n = 99)
P valueb
0 1 (0.3) 1 (0.3)
0 0 0
4 (4.0) 1 (1.0) 0
b0.001 0.548 0.769
1 (0.3) 1 (0.3) 2 (0.6)
0 2 (2.9) 3 (4.4)
93 (93.9) 5 (5.1) 2 (2.0)
b0.001 0.001 0.05
4 (1.2) 1 (0.3)
2 (2.9) 0
6 (6.1) 0
Abbreviations: ICU, intensive care unit; IUFD, intrauterine fetal death. a Values are given as number (percentage) unless indicated otherwise. b For comparison of all three groups.
0.06 0.769
180
4. Discussion
188
In the present study, approximately one-third of all women who presented at the labor room in the study period had a previous cesarean delivery. The present results demonstrate that, with careful selection of candidates, successful TOLAC can reach a reasonably acceptable level (79.6%) even in a rural area of a low-income country. A success rate of TOLAC of 60%–80% has been reported in highresource countries [3]. By contrast, most studies from low-income countries have shown a much lower success rate of TOLAC, ranging from as low as 28% to 60% [1,5–7]. Various reasons for this low rate have been hypothesized—e.g. late access to health care after already established labor, poor educational status, indication for previous cesarean not known, and poor record keeping of previous cesarean delivery [1,5–7]. In the present study, few women had scar rupture (0.4%). One occurred in a woman who presented late in the second stage of labor with IUFD; scar rupture was identified in the postpartum period. Among the remaining women who were selected for TOLAC, therefore, there was one scar rupture and four cases of scar dehiscence, all with optimal neonatal outcome. This is in sharp contrast to studies in lowresource countries, where the incidence of scar rupture reportedly ranges from 1.3% [1] to 4.2% [8]. The high success rate in the present study might be due to appropriate selection of women, and intensive intrapartum monitoring with early recognition of the catastrophic events of scar dehiscence or rupture. A major limitation of the study is that a substantial number of women were not enrolled for TOLAC, owing to a history of previous uterine scar extension or unknown nature of the scar (n = 517), in accordance with the study protocol. Such exclusion might have confounded the high success rate of TOLAC (79.6%) observed in the study. In our opinion, however, this further signifies that careful selection of women for TOLAC is essential to have a favorable outcome (i.e. vaginal delivery)
189
D
75.0% (63/84) for women with NPL, and 68.0% (32/47) for women with failure of induction. Among 226 women with previous cesarean for AFD, 24 (10.6%) had a repeat cesarean for the same indication. Similarly, 11 (13.1%) of 84 had a repeat cesarean for NPL, and 5 (10.6%) of 47 had a repeat cesarean for failure of induction. Because women with malpresentation in the current pregnancy were excluded from the study, the percentage of women who required repeat cesarean for this indication could not be estimated.
E
T
C
E
169 170
R
167 168
R
165 166
N C O
163 164
U
161 162
P
t1:22 t1:23 t1:24 t1:25
159 160
b0.001 b0.001
R O
– –
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
181 182 183 184 185 186 187
190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218
4
Table 3 Relationship of various predictive factors with mode of delivery.a
t3:4 t3:5 t3:6 t3:7 t3:8 t3:9 t3:10 t3:11 t3:12 t3:13 t3:14 t3:15 t3:16 t3:17 t3:18 t3:19 t3:20
Mode of onset of labor Spontaneous labor Induced labor Augmentation of labor Bishop score POG at delivery, d POG N280 d Birth weight, kg Previous Present Present N500 g more than previous Previous vaginal delivery Previous successful TOLAC Inter-pregnancy interval, mo 18–24 24–36 N36
Normal vaginal delivery (n = 316)
Operative vaginal delivery (n = 67)
Cesarean delivery (n = 99)
P valueb
264 (83.5) 14 (4.4) 38 (12.0) 7 (6–8) 274 (269–279) 74 (23.4)
54 (80.6) – 13 (19.4) 7 (6–9) 277 (273–281) 22 (32.8)
65 (65.6) 20 (20.2) 14 (14.1) 6 (5–8) 275 (272–281) 32 (32.3)
0.001 b0.001 0.269 b0.001 0.009 0.098
2.7 (2.5–3.0) 2.7 (2.5–3.0) 92 (29.1) 33 (10.4) 17 (5.4) 33 (10.4) 98 (31.1) 185 (58.5)
2.7 (2.5–3) 3.0 (2.7–3.2) 22 (32.8) 2 (3.0) 1 (1.5)
2.7 (2.5–3.0) 2.8 (2.5–3.0) 35 (35.3) 6 (6.1) 1 (1)
0.130 0.010 0.915 0.071 0.081
8 (11.9) 19 (28.3) 40 (59.7)
8 (8.1) 27 (27.3) 64 (64.6)
0.695 0.745 0.557
t3:21 t3:22 t3:23
Abbreviations: POG, period of gestation; TOLAC, trial of labor after cesarean. a Values are given as number (percentage) or median (interquartile range), unless indicated otherwise. b For comparison of all three groups.
219
and to prevent catastrophic outcomes (e.g. scar rupture, peripartum hysterectomy, and fetal death). Spontaneous onset of labor, favorable Bishop score, and birth weight were significantly associated with the incidence of successful TOLAC in the present study; these results are comparable with previous data [1, 3,10]. However, a current birth weight of 500 g or more higher than the previous birth weight was not found to affect the incidence of successful TOLAC. Previous vaginal delivery, previous successful TOLAC, interdelivery interval, and a period of gestation of more than 40 weeks did not differ significantly among the three study groups. Prior vaginal birth and specifically prior successful TOLAC (i.e. vaginal birth after CS) have been observed to be very strong predictors of successful TOLAC [11–17]. The present observation is thus contrary to previous evidence, probably owing to the low number of women in these subgroups in the present study (n = 49 and n = 19, respectively). Evidence in favor of interdelivery interval [18] and a period of gestation of more than 40 weeks is controversial, with some studies indicating [19,20] and some negating [21] any benefit of these variables. Women with cesarean after TOLAC had a significantly higher incidence of maternal complications in terms of scar dehiscence and blood loss in the present study. Admission to the neonatal intensive
234 235 236 237 238 239 240
259
E
D
P
Conflict of interest
T
C
E
232 233
R
230 231
R
228 229
O
226 227
The authors have no conflicts of interest.
C
224 225
241
N
222 223
care unit also approached statistical significance, with a higher occurrence among women with cesarean after TOLAC. This observation is in accordance with previous studies in which failed TOLAC was associated with worse maternal and fetal outcomes as compared with successful TOLAC [22–25]. In summary, under intensive labor monitoring and with appropriate selection of women, trial of labor among women with previous cesarean has been shown to be a reasonable option, even in a rural area of a lowresource country with limited facilities. However, TOLAC can be risky in small centers lacking the continuous availability of intensive electronic labor monitoring and facilities for operative delivery. Scar dehiscence and/or rupture—although rare in the present study—are unpredictable and catastrophic in terms of maternal and neonatal outcomes, and no predictive factor has been shown to be consistently associated with a successful outcome of TOLAC. Nevertheless, it might not be justifiable to carry out such a high number of cesarean procedures, especially in rural areas of low-resource countries with limited resources, to prevent one scar rupture or fetal death.
U
220 221
F
Specific predictive factor
O
t3:3
R O
t3:1 t3:2
A. Soni et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx
Fig. 2. Relationship between successful TOLAC and indication for previous cesarean delivery. Abbreviations: TOLAC, trial of labor after cesarean; AFD; acute fetal distress; NPL, non-progress of labor; FoI, failure of induction; MP, malpresentation; RI, repeat cesarean because of similar indication; CS, cesarean; VD, vaginal delivery.
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258
260
A. Soni et al. / International Journal of Gynecology and Obstetrics xxx (2015) xxx–xxx
F
O
R O
[1] Madaan M, Agrawal S, Nigam A, Aggarwal R, Trivedi SS. Trial of labour after previous caesarean section: the predictive factors affecting outcome. J Obstet Gynaecol 2011; 31(3):224–8. [2] National Institutes of Health Consensus Development Conference Panel. National Institutes of Health Consensus Development conference statement: vaginal birth after cesarean: new insights March 8-10, 2010. Obstet Gynecol 2010;115(6): 1279–95. [3] American College of Obstetricians and Gynecologists. ACOG Practice bulletin no. 115: Vaginal birth after previous cesarean delivery. Obstet Gynecol 2010;116(2 Pt 1): 450–63. [4] Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S, et al. Births: final data for 2005. Natl Vital Stat Rep 2007;56(6):1–103. [5] Gupta S, Jeeyaselan S, Guleria R, Gupta A. An observational study of various predictors of success of vaginal delivery following a previous cesarean section. J Obstet Gynaecol India 2014;64(4):260–4. [6] Balachandran L, Vaswani PR, Mogotlane R. Pregnancy outcome in women with previous one cesarean section. J Clin Diagn Res 2014;8(2):99–102. [7] Agarwal A, Chowdhary P, Das V, Srivastava A, Pandey A, Sahu MT. Evaluation of pregnant women with scarred uterus in a low resource setting. J Obstet Gynaecol Res 2007;33(5):651–4. [8] George A, Arasi KV, Mathai M. Is vaginal birth after cesarean delivery a safe option in India? Int J Gynecol Obstet 2004;85(1):42–3. [9] Jerbi M, Hidar S, Zardi H, Chaieb A, Khairi H. Previous cesarean scar exploration following vaginal delivery and hemorrhagic morbidity. Int J Gynecol Obstet 2006; 92(2):135–6. [10] 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(5):1644–8. [11] Mercer BM, Gilbert S, Landon MB, Spong CY, Leveno KJ, Rouse DJ, et al. Labor outcomes with increasing number of prior vaginal births after cesarean delivery. Obstet Gynecol 2008;111(2 Pt 1):285–91. [12] 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(3 Pt 2):1016–23.
P
262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 331
[13] Cahill AG, Stamilio DM, Odibo AO, Peipert JF, Ratcliffe SJ, Stevens EJ, et al. Is vaginal birth after cesarean (VBAC) or elective repeat cesarean safer in women with a prior vaginal delivery? Am J Obstet Gynecol 2006;195(4):1143–7. [14] McNally OM, Turner MJ. Induction of labour after 1 previous Caesarean section. Aust N Z J Obstet Gynaecol 1999;39(4):425–9. [15] Macones GA, Hausman N, Edelstein R, Stamilio DM, Marder SJ. Predicting outcomes of trials of labor in women attempting vaginal birth after cesarean delivery: a comparison of multivariate methods with neural networks. Am J Obstet Gynecol 2001; 184(3):409–13. [16] Weinstein D, Benshushan A, Tanos V, Zilberstein R, Rojansky N. Predictive score for vaginal birth after cesarean section. Am J Obstet Gynecol 1996;174(1 Pt 1):192–8. [17] Flamm BL, Geiger AM. Vaginal birth after cesarean delivery: an admission scoring system. Obstet Gynecol 1997;90(6):907–10. [18] Huang WH, Nakashima DK, Rumney PJ, Keegan Jr KA, Chan K. Interdelivery interval and the success of vaginal birth after cesarean delivery. Obstet Gynecol 2002;99(1): 41–4. [19] Yeh S, Huang X, Phelan JP. Postterm pregnancy after previous cesarean section. J Reprod Med 1984;29(1):41–4. [20] Kiran TS, Chui YK, Bethel J, Bhal PS. Is gestational age an independent variable affecting uterine scar rupture rates? Eur J Obstet Gynecol Reprod Biol 2006;126(1): 68–71. [21] Coassolo KM, Stamilio DM, Paré E, Peipert JF, Stevens E, Nelson DB, et al. Safety and efficacy of vaginal birth after cesarean attempts at or beyond 40 weeks of gestation. Obstet Gynecol 2005;106(4):700–6. [22] 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(25):2581–9. [23] Macones GA, Peipert J, Nelson DB, Odibo A, Stevens EJ, Stamilio DM, et al. Maternal complications with vaginal birth after cesarean delivery: a multicenter study. Am J Obstet Gynecol 2005;193(5):1656–62. [24] Flamm BL, Newman LA, Thomas SJ, Fallon D, Yoshida MM. Vaginal birth after cesarean delivery: results of a 5-year multicenter collaborative study. Obstet Gynecol 1990;76(5 Pt 1):750–4. [25] McMahon MJ, Luther ER, Bowes Jr WA, Olshan AF. Comparison of a trial of labor with an elective second cesarean section. N Engl J Med 1996;335(10):689–95.
D
References
U
N C O
R
R
E
C
T
E
261
5
Please cite this article as: Soni A, et al, A prospective observational study of trial of labor after cesarean in rural India, Int J Gynecol Obstet (2015), http://dx.doi.org/10.1016/j.ijgo.2014.11.007
296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330