Successful treatment of cervical incompetence using a modified laparoscopic cervical cerclage technique: a cohort study

Successful treatment of cervical incompetence using a modified laparoscopic cervical cerclage technique: a cohort study

G Model EURO 8593 1–5 European Journal of Obstetrics & Gynecology and Reproductive Biology xxx (2014) xxx–xxx Contents lists available at ScienceDir...

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EURO 8593 1–5 European Journal of Obstetrics & Gynecology and Reproductive Biology xxx (2014) xxx–xxx

Contents lists available at ScienceDirect

European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb

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Successful treatment of cervical incompetence using a modified laparoscopic cervical cerclage technique: a cohort study

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Lu Lou 1, Shu-qin Chen 1, Hong-ye Jiang, Gang Niu, Qiong Wang, Shu-zhong Yao *

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Department of Obstetrics and Gynecology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, PR China

A R T I C L E I N F O

A B S T R A C T

Article history: Received 10 July 2013 Received in revised form 14 February 2014 Accepted 23 May 2014

Objective: We introduce a modified surgical method for laparoscopic cervical cerclage (LCC) and compare the operative data and obstetric outcomes to those obtained by traditional vaginal cerclage (TVC). Study design: This is a prospective cohort study in a university-affiliated hospital from August 2008 through February 2013. Nineteen patients treated by LCC were prospectively monitored and the treatment outcomes were compared to a control group consisted of 25 patients that were retrospectively studied and treated with TVC using traditional McDonald suture. Laparoscopic cervical cerclage was performed with Mersilene tape and a modified surgical technique. Perioperative complications and obstetric outcomes were compared between LCC and TVC treatment groups. Results: No perioperative complications occurred during LCC treatment. Of the 19 LCC patients, 15 (78.9%) became pregnant during the study period. The fetal salvage rate was 92.3% (12/13) and no adverse events were encountered. The mean gestational age in LCC group was 36.4 weeks, and it was 17.4 weeks longer than their previous pregnancy age, which was significantly higher than obtained by TVC. Conclusion: This modified technique for laparoscopic cervical cerclage demonstrates good obstetric outcomes with low risk of adverse events, which may provide a reasonable alternative to achieve pregnancy success in patients with cervical incompetence. ã 2014 Published by Elsevier Ireland Ltd.

Keywords: Cervical cerclage Laparoscopy Vaginal cerclage Cervical incompetence

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Introduction

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Cervical incompetence is defined as the inability to retain an intrauterine pregnancy to full term due to structural or functional insufficiency of the cervix [1]. It occurs in 0.5%–1% of all pregnancies and has a recurrence risk of up to 30% [2]. The traditional vaginal approach of cervical cerclage during mid-term pregnancy [3] has been used for several decades and is effective for most patients. However, a small minority are not successfully treated by the transvaginal approach. For example, patients with anatomically deformed, deeply lacerated, or severely scarred cervices from previous failed vaginal cerclage cannot be treated by placement of a transvaginal suture. In 1965, transabdominal cervical cerclage was first described [4], and subsequent studies reported successful results in patients for whom a vaginal approach was deemed impossible. In recent years, a laparoscopic cervical cerclage approach was described in several case series,

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* Corresponding author at: 58 Zhongshan Er Road, Guangzhou, Guangdong 510080, PR China. Tel: +86 13602834127. E-mail addresses: [email protected], [email protected] (S.-z. Yao). 1 These authors contributed equally to this study.

and results compared favorably to the traditional laparotomy approach [5]. The present study reports a series of cervical incompetence cases treated by laparoscopic cervical cerclage (LCC) using a modified surgical technique which is easy-operating, minimal invasive and highly effective. Operative details and obstetric outcomes were compared with those obtained using traditional vaginal cerclage (TVC).

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Materials and methods

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A prospective observational cohort study was conducted from August 2008 through February 2013 at the First Affiliated Hospital of Sun Yat-sen University (Guangzhou, China). The study was approved by the institutional ethics board and informed written consent was obtained from all patients. The indications for laparoscopic cerclage included a history of cervical incompetence/insufficiency, with or without congenital short cervix or traumatic/surgical damage rendering the vaginal approach difficult or previous failed transvaginal cerclage. Nineteen patients were selected for LCC and were prospectively monitored for perioperative and postoperative complications, conception success, and successful delivery. We performed a parallel

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http://dx.doi.org/10.1016/j.ejogrb.2014.05.032 0301-2115/ ã 2014 Published by Elsevier Ireland Ltd.

Please cite this article in press as: Lou L, et al.. Successful treatment of cervical incompetence using a modified laparoscopic cervical cerclage technique: a cohort study. Eur J Obstet Gynecol (2014), http://dx.doi.org/10.1016/j.ejogrb.2014.05.032

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Table 1 Patient demographics. Demographic

LC groupa (n = 19)

VC groupb (n = 25)

Maternal age at cerclage (y, [median, range]) No. of prior T2c loss (median, range) No. of preterm labor< 34 w (median, range) Patients with prior failed vaginal cerclage (%) No. of prior failed vaginal cerclage (median, range) Prior gestational age (for pregnancies continued beyond the first trimester [median, range]) Patients with cervical abnormality (laceration at delivery) Patients with prior cone biopsy (%)

31 (27–35) 2.5 (1–5) 0 n = 11 (57.8%) 1 (0–2) 21 (16–27) n = 4 (21.1%) n = 1 (5.3%)

32 (28–41) 2 (0–3) 0.24 (0–2) n = 3 (12%) 0.08 (0–1) 23 (17–30) n=0 n=0

Note: There were no significant differences of demographics between the two groups. a LC group, laparoscopic group. b VC group, vaginal group. c T2, second trimester.

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retrospective analysis of 25 patients treated by TVC during the same period. For TVC group, all patients were clinically diagnosed with incompetent cervix before pregnancy and were treated with prophylactic TVC using traditional McDonald suture in the second trimester of pregnancy. The demographic data of the two treatment groups is shown in Table 1.

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Technique description

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For LCC group, prophylactic laparoscopic cerclage was performed as an interval procedure before pregnancy. The cerclages were all placed in the same fashion by one surgeon.

Surgical preparation

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Preoperative preparations were similar to those of other laparoscopic surgeries. The patient was prepared in the dorsal lithotomy position with a urinary catheter in situ. A transcervical uterine manipulator was used to facilitate uterine manipulation. A 3port operative laparoscopy system was used. Initial abdominal entry is achieved through the closed Veress technique at the umbilicus. Abdominal insufflation was maintained at 12–15 mmHg using CO2. Step 1: development of the paravesical and vesicouterine spaces. The vesicouterine peritoneum was incised using monopolar forceps and a combination of sharp and blunt dissection. The

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Fig. 1. Intraoperative photographs illustrating the modified laparoscopic cervical cerclage method. (A) Step 1: Create paravesical and vesicouterine spaces. (B and C) Step 2: Identify the contours of the uterine vessels on both sides of the uterine isthmus. (D–G) Step 3: Place the Mersilene tape around the cervicourerine junction using a direct suture technique. (H) Step 4: Ensure that the tape had not passed through the cervical canal by hysteroscopy. (I) Step 5: Tie the tape posteriorly with an intracorporeal knot.

Please cite this article in press as: Lou L, et al.. Successful treatment of cervical incompetence using a modified laparoscopic cervical cerclage technique: a cohort study. Eur J Obstet Gynecol (2014), http://dx.doi.org/10.1016/j.ejogrb.2014.05.032

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bladder was retracted away from the lower uterine segment and anterior cervix to create a vesicouterine space. Step 2: identification of the contour of uterine vessels. In step 2, the uterine vessels were identified. Incision of the peritoneum was extended and the anterior leaf of the broad ligament was opened. The contour of the uterine vessels were identified on both sides of the uterine isthmus. Up to date references, the standard step of cervico-isthmic cervical cerclage is creation of broad ligament peritoneal window [6]. The posterior peritoneum should be opened to create a window in the broad ligament, which allows for caudal displacement of the ureters, identification of the uterine vessels, and a space for a needle to be passed through into the cervix. In our study, this step was modified. Since we could clearly see the contours of the uterine vessels, it was unnecessary to open a window in the broad ligament. Step 3: placement of suture material. We used a 5-mm Mersilene tape with straight needle for direct suture. To avoid uterine vessel and ureter damage, the straight needle was carefully inserted into the exposed anterior surface of the cervix on the right side at the level of the cervico-isthmic junction and medially to the uterine vessels but not into the broad ligament. The needle was passed through the muscular layer of the cervix, with a small piece of cervical tissue remaining outside the noose. The tape was passed in the anterior to posterior direction, and the needle withdrawn from the posterior surface of the cervix on the same side. In a similar fashion, the straight needle was inserted in the anterior surface of the cervix on the left side and passed in the anterior to posterior direction through the muscular layer. Step 4: hysteroscopy check and cerclage knot secured. After placing the tape around the internal os, a hysteroscopy check was conducted to ensure that the tape had not passed through the cervical canal. The knot was firmly tied on the posterior side to avoid potential bladder irritation. The tension of the noose can be adjusted over a transcervical 6# Hegar dilator. The visceral peritoneum was left unclosed. At the conclusion of the procedure, the laparoscopic ports are removed, the gas evacuated, and the abdominal wall and skin are repaired in the usual fashion. A single dose of antibiotics was administered perioperatively. All patients were encouraged to

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Table 2 Perioperative data. Variable (median, range)

LC group (n = 19)

VC group (n = 25)

Duration of surgery (min) Blood loss during surgery (mL) Hospital stay after surgery (days) Patients with perioperative complications (%)

29 (20–55) 26 (20–50) 2 (2–3) n=0

18 (10–35) 10 (0–15) 2.5 (2–4) n = 1 (4%)

Note: There were no significant differences of demographics between the two groups.

attempt conception immediately after surgery. The ideograph of the surgery is shown in Fig. 2 and the surgical steps are shown in Q2 Fig. 1A–I. The control group was treated by prophylactic traditional McDonald vaginal cerclage with 5-mm Mersilene band during the second trimester of pregnancy. In order to reveal fetal congenital deformity, three dimensional ultrasonography was performed during 17–22 weeks of preganancy before surgery. The mean pregnancy age of cerclage was 19.9 (17.0–22.6) weeks.

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Results

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Surgeries were successfully performed in all patients in both the LCC and TVC treatment groups. There were no significant differences in the perioperative data between the two groups although the duration of surgery seems slightly longer and blood loss seems slightly more in LCC group (Table 2). In the laparoscopic group, no patient required laparotomy, and no perioperative complications occurred, such as uterine vessel bleeding, adjacent organ damage or perioperative infection. In the TVC group, two patients experienced postoperative pregnancy loss due to premature rupture of membranes one week after surgery. The details of obstetric outcomes are presented in Tables 3 and 4. Fifteen of the patients undergoing LCC conceived during the course of our study, while four were not yet pregnant, possibly due to the short interval after surgery. One patient was still at her 18 weeks of gestation at writing, and was excluded in the following analyses. The overall fetal salvage rate was defined as the number of perinatal survival per number of pregnancies lasted more than 12 weeks of gestation. In successful cases, we determined the gestational age at the time of delivery. In the LCC group, there were 12 living children out of 13 pregnancies for a 92.3% perinatal survival rate. All these infants were discharged with their parents. In the TVC group, there were 22 living children out of 25 pregnancies (88% perinatal survival, all discharged with parents but one had sequelae of prematurity). The mean gestational age for pregnancies beyond the 1st trimester in the two groups were 36.4 and 34.7 weeks respectively, which showed no statistically differences although delivery age in LCC group seems longer. However, in LCC group, the mean delivery age was 17.4 weeks longer than the previous

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Table 3 Main outcome of LC group patients.

Fig. 2. Schematic chart of laparoscopic cervical cerclage insertion using our modified surgical method.

Variable

LC group

Not pregnant Still being pregnant T1b loss T2c loss Preterm labor Full-term labor

n = 4a n=4 n=1 n=1 n=1 n=8

a Three patients were not intent to be pregnant yet, one was with male-factor infertility. b T1, first trimester. c T2, second trimester.

Please cite this article in press as: Lou L, et al.. Successful treatment of cervical incompetence using a modified laparoscopic cervical cerclage technique: a cohort study. Eur J Obstet Gynecol (2014), http://dx.doi.org/10.1016/j.ejogrb.2014.05.032

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Table 4 Comparison of details of obstetric outcomes. Variable

LC group (n = 10)

VC group (n = 25)

P value

No. of fetal loss in the second trimester (%) No. of preterm labor (%) No. of full-term labor (%) Gestational age for patients beyond 1st trimestera Gestational age for full-term labor No. of neonatal department admissions (%) No. of neonatal death (%) No. with long-term sequelae of prematurity (%) Weeks of pregnancy gained (w [median, range])a No. of living children Fetal salvage rate (for pregnancy continued beyond the first trimester) (%)

n = 1 (10%) n = 1 (10%) n = 8 (80%) 38 (20–39) 38.1 (n = 8) n = 1 (10%) n=0 n=0 16.5 (1–23) n=9 90%

n = 2 (8%) n = 7 (28%) n = 16 (64%) 35 (27.6–37.7) 38 (n = 16) n = 9 (36%) n = 2 (8%) n = 1(4%, retinopathy) 11 (2.6–29) n = 22 88%

NS NS NS 0.005 NS NS NS NS 0.039 – NS

Note: NS = not significant. a Values are median (range).

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delivery age, while in TVC group, this number was 11 weeks, which made a statistically differences between the two groups (p = 0.039). Only one LCC patient experienced premature rupture of the membrane (at 20 weeks) and the fetus was aborted vaginally after removing the cerclage by mini-laparotomy. Other viable pregnancies in LCC group were delivered by caesarean section. The cervical sutures were left in situ at the time of caesarean section. In TVC group, the sutures were removed at 37 weeks of gestation or with the onset of labor if earlier, and the patients were allowed to deliver as appropriate.

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Discussion

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Cervical incompetence is traditionally treated with a TVC during the late first trimester or early second trimester of pregnancy. However, TVC fails in a part of patients due to extremely short, deformed, and/or scarred cervices. A transabdominal approach for cervical cerclage was indicated in the select group of patients with a cervix that is too short or scarred for a TVC or who have previously failed a TVC. Different from the TVC, the cerclage was placed at the level of the cervicoisthmic junction in transabdominal cerclage, which theoretically made the cervix more strengthened to act as the barrier against intrauterine pressure during gestation. Some studies have shown better results of TAC than TVC, with higher perinatal survival rate. However, the surgery technique itself was more complex, and the rate of serious operative complications such as the need for transfusion or

damage to surrounding viscera was also higher in TAC. Moreover, if it is done before pregnancy, postoperative pelvic adhesion could lead to secondary infertility. As a result, the indications for this more invasive approach have generally been limited to the strictly selected group described above. In order to reduce the operative morbidity, laparoscopic approach of cervicoisthmic cerclage placement has recently been developed. In several single case reports and small case series, preliminary results suggest that the risk of complications and obstetric outcomes compare favorably with the laparotomy approach [5,7,8,9]. We performed a systematic literature search of PubMed, EMBASE, and the Cochrane database for studies on the laparoscopic approach. Sixteen studies in English encompassing 136 patients (Table 5) yielded a mean fetal survival rate of 81.6% (75–100%, n = 130) and an operative complication rate of 6% (0– 10.7%, n = 136). The main perioperative complications included excessive blood loss due to uterine vessel damage, damage to the ureters, cystotomy, conversion to laparotomy due to surgical invisibility (which occurs more frequently in pregnant patients), perioperative pregnancy loss, and ruptured fetal membranes. Whittle et al. [5] reported the largest sample (65-patient) cohort study of laparoscopic cervical cerclage to date with fetal survival rate of 80% and 10.7% of perioperative complication rate. In the present study, we described a modified surgical method for laparoscopic abdominal cerclage to avoid many complications associated with previous techniques. Instead of creating windows in broad ligament peritoneal membranes, we directly inserted the

Table 5 Cumulative results of cervico-isthmic cerclage placed by laparoscopy. Cerclage by laparotomy: study and year

Patient no.

The timing of surgery

Patient no. conceived

Pregnancy no.

Intraoperative complication rate (%)

Fetal survival rate (%)

Average gestational age at birth

Lesser KB et al., 1998 Mingione MJ et al., 2003 Cho CH, et al., 2003 Gallot D et al., 2003 Ghomi A et al., 2006 Aboujaoude R et al., 2007

1 11 20 3 1 1

Duriung pregnancy Before pregnancy During pregnancy Before pregnancy Before pregnancy During pregnancy

– 10 – 2 1 –

0 9 0 0 0 0

100 83 95 100 100 Not reported

Not reported 37.1 36.2 38 38.4 Not reported

Agdi M et al., 2008 Reid GD et al., 2008 Liddell HS and Lo C., 2008 Whittle WL et al., 2009 Fechner AJ et al., 2009 Carter JF et al., 2009

1 3 11 65 1 12

1 – 10 26, n = 34 – 12

0 0 0 10.7 0 0

– Not reported 100 80 100 75

– Not reported Not reported 35.8 37 Not reported

Pereira RM et al., 2009 Pawłowicz P et al., 2009

1 2

Before pregnancy During pregnancy Before pregnancy 34 not pregnant, 31 pregnant Pregnant 5 during pregnancy and 7 before pregnancy Before pregnancy Before pregnancy

1 12 21 2 1 Not reported 1 3 10 67 1 12

0 0

100 Not reported

38 Not reported

Murray A et al., 2011 DaCosta V et al., 2011 Total Current study

1 3 137 19

Before pregnancy Before pregnancy – Before pregnancy

1 2 68 15

2 Not reported 1 2 136 15

Not reported 0 6, n = 136 0

100 100 81.6, n = 130 92.9

28 37 36, n = 103 38.2

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Please cite this article in press as: Lou L, et al.. Successful treatment of cervical incompetence using a modified laparoscopic cervical cerclage technique: a cohort study. Eur J Obstet Gynecol (2014), http://dx.doi.org/10.1016/j.ejogrb.2014.05.032

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straight needle into the anterior surface of the cervix on one side with a small piece of cervical tissue remaining outside the noose to decrease the possibility of damage to the uterine vessels and ureters, excessive blood loss, and compression of the uterine vessels. The surgical duration was relatively short and blood loss was minimal, with a 0% perioperative complication rate up to now. In our series, patients in the LCC group achieved satisfied results in obstetric outcomes. The fetal survival rate in the LCC group was as high as 92.3% with a mean gestational age of 36.4 weeks, and weeks gained for the gestational age to previous pregnancies was 17.4 weeks. No long-term sequelae of prematurity happened. These results are in accordance with past studies (Table 5) demonstrating a total fetal survival rate after laparoscopic abdominal cerclage of 81.6% (75–100%, n = 130) and an average gestational age at birth of 36 weeks (n = 103), which was reported to be better than the TVC approach. However, limited to the small case number, fetal salvage rate and mean gestational age in the present study were similar between the two groups. Only weeks gained for the gestational age to previous pregnancies showed statistically superiority in LCC group. To sum up, our results showed that this modified approach maintained the strong point of TAC to placement of a cervicoisthmic cerclage at the level of the cervicoisthmic junction, while it simplified the surgical steps to be much easier to master by most gynecologist and it further reduced the operative morbidity to be as minimal invasive as TVC. Based on our results, this modified LCC method is safe and probably more effective, and its indications can be extended to those of traditional transvaginal cerclage. Some may argue that LCC have obvious disadvantages including the need of another laparoscopic surgery or laparotomy to remove the tape once second-trimester miscarriage or intrauterine fetal death happens, and the delivery mode for full-term or premature delivery can only be cesarean section. However, for the high risk patients who have experienced painful recurrent fetal losses and strongly demand for a baby to take home, it is worth the risk of another laparoscopic surgery or mini-laparotomy for a probably better obstetric result. Meanwhile, cesarean section seems to be minor drawback for these patients given their complex and difficult obstetric history. Another controversial point is the optimal time for cerclage surgery. Most studies reported that the timing of cerclage placement did not influence the gestational age at delivery, although cerclage failure did occur more often when inserted during pregnancy [5,9]. In our study, all patients underwent the modified LCC surgery before pregnancy. We believe cerclage insertion should be avoided during pregnancy for the following reasons. First, the pelvic cavity and the uterus are more congested during pregnancy and surgeries during pregnancy can lead to excessive bleeding. Second, since the gravid uterus is enlarged, the surgical visibility is relatively poor and transcervical uterine manipulators cannot be used, so cerclage placement is a greater challenge for surgeons. Third, postoperative rupture of membranes and fetal loss are still possible following transabdominal cervical cerclage; if conducted before pregnancy, such considerations can

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be neglected. In our series, to ensure postoperative fertility and to facilitate embryo discharge in case of miscarriage during the first and early second trimester, we placed a 6# Hegar dilator transcervically when tying the knot as reported by Whittle et al. and others [5,10]. The fertility rate was not affected postoperatively, and fetal tissue could be discharged in our case of early miscarriage. One possible limitation of our study is that the experimental group and the control group are not perfectly matched. As an experimental group, the LCC group is a prospective (cohort) group and the control group is a retrospective group (TVC). The comparisons between these two groups are not perfectly comparable and effective. In addition, it would be even better if there is one more control group of transabdominal cervical cerclage, so that it will be better to show the efficacy of these three different surgical methods. Randomized controlled trials with large sample are needed to further confirm the safety, practicability and effectiveness of this modified LCC approach, and to confirm the idea of its expanded indications. In conclusion, our modified method for laparoscopic cerclage demonstrates good obstetric outcomes with low risk of adverse events. This cerclage method may provide a reasonable alternative to achieve pregnancy success in patients with cervical incompetence.

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Conflict of interest

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None of the authors have commercial, proprietary, or financial interests in the products or companies mentioned in this article. Further, there are no disclosures to report for this paper.

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References

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Please cite this article in press as: Lou L, et al.. Successful treatment of cervical incompetence using a modified laparoscopic cervical cerclage technique: a cohort study. Eur J Obstet Gynecol (2014), http://dx.doi.org/10.1016/j.ejogrb.2014.05.032