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doi:10.1111/jog.12207
J. Obstet. Gynaecol. Res. 2013
Emergency cerclage versus expectant management for prolapsed fetal membranes: A retrospective, comparative study Shigeru Aoki1, Emi Ohnuma1, Kentaro Kurasawa1, Mika Okuda1, Tsuneo Takahashi1 and Fumiki Hirahara2 1
Perinatal Center for Maternity and Neonate, Yokohama City University Medical Center, and 2Department of Obstetrics and Gynecology, Yokohama City University Hospital, Yokohama, Japan
Abstract Aim: To compare outcomes after emergency cerclage versus expectant management for prolapsed fetal membranes in women with cervical incompetency. Methods: The January 2000–December 2012 hospital database was analyzed to identify women managed for prolapsed fetal membranes who did not have premature rupture of membranes, clinically discernible chorioamnionitis, or treatment-resistant uterine contractions from 15 to 26 weeks of gestation retrospectively. Durations of pregnancy prolongation and numbers of deliveries after 32 and 28 weeks were compared between women undergoing emergency cervical cerclage and those receiving expectant management. Results: Fifteen of the 35 women underwent emergency cervical cerclage (‘cerclage group’), while the other 20 were managed expectantly (‘bedrest group’). In the cerclage group, median gestational ages at procedure and delivery times were 22.6 (15.9–26.1) and 32.4 (19.4–41.6) weeks, respectively. Median gestational ages on admission and at delivery in the bedrest group were 23.4 (21.1–26.4) and 26.0 (23.1–36.4) weeks, respectively. The median duration of pregnancy prolongation was 44 days (4–165) in the cerclage group and 12.5 days (2–93) in the bedrest group (P < 0.01). Numbers of deliveries after 28 and 32 weeks were both significantly higher in the cerclage than in the bedrest group (P < 0.05). Conclusion: In women with prolapsed fetal membranes but no signs of infection or painful uterine contractions, emergency cervical cerclage prolonged pregnancy duration as compared with expectant management. Key words: cervical insufficiency, emergency cerclage, expectant management, prolapsed fetal membrane, prolongation of pregnancy.
Introduction Cervical incompetency is defined as a condition in which the cervical ostium opens and prolapsed fetal membranes occur without subjective symptoms of threatened miscarriage or preterm labor including external bleeding and uterine contraction during the
second trimester of pregnancy.1 Along with chorioamnionitis, cervical incompetency is one of the main causes of premature delivery, but a standard treatment procedure has not yet been established. It is an important contributor to preterm birth and second-trimester pregnancy loss,2 and is associated with poor perinatal outcomes despite the current
Received: February 21 2013. Accepted: June 11 2013. Reprint request to: Dr Shigeru Aoki, Perinatal Center for Maternity and Neonate, Yokohama City University Medical Center, 4-57 Urafunecyou, Minami-ku, Yokahama City, Kanagawa 232-0024, Japan. Email:
[email protected] Conflict of interest: The authors have no conflicts of interest to declare. The authors confirm that the results of this manuscript havenot been distorted by research funding or conflicts of interest.
© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
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availability of highly advanced neonatal care. Therefore, prolongation of gestation is the most important aspect of managing cervical incompetency. Prolapsed fetal membranes is thought to be an advanced stage of cervical incompetency. Although several studies showing the outcome of expectant management versus emergency cerclage show a benefit of the emergency cerclage,3–8 there is little evidence about whether women with amniotic sac prolapse should receive conservative therapy or undergo cervical cerclage. In the present study, we classified women with cervical incompetency complicated by prolapsed fetal membranes into two groups – those who underwent emergency cervical cerclage and those who received expectant management – and we retrospectively compared pregnancy outcomes between the two groups.
Methods Data were retrospectively analyzed using the medical records of women who had been treated for prolapsed fetal membranes between January 2000 and December 2012 at the Perinatal Center for Maternity and Neonate, Yokohama City University Medical Center, Yokohama. Prolapsed fetal membranes were diagnosed to be present when an amniotic sac was identified under speculum examination, with cervical internal os dilation (defined as 1–4 cm). An amniotic sac found at the level of the external os was referred to as ‘visible amniotic sac’ and that after progression from the visible state to protrusion into the vagina beyond the external os as ‘protruding amniotic sac’. Inclusion criteria were: (i) a singleton viable pregnancies between 15 + 0 and 26 + 6 gestational weeks; (ii) no premature rupture of membranes (PROM); (iii) no clinically discernible chorioamnionitis (including fever with temperature >38.0°C, uterine tenderness and foul-smelling discharge); (iv) no obvious fetal malformation; (v) no heavy bleeding; and (vi) no treatment-resistant uterine contractions. Thirty-five met these criteria. For the purpose of retrospective analysis, the 35 women were allocated according to the mode of treatment to emergency cerclage group or bedrest group. After admission, all women with prolapsed fetal membranes received i.v. administration of tocolytic agents and cardiotocogram was performed for a few hours to identify treatment-resistant uterine contractions. The cerclage group consisted of 15 women (eight with a visible amniotic sac and seven with a protruding amniotic sac), Cerclage was performed under spinal
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anesthesia in a head down position within 24 h of admission. McDonald cerclage was the first choice for this procedure and Shirodkar cerclage was also performed at the discretion of each patient’s physician. Mersilene tape (5-mm) was used for the cerclage. The number of patients for McDonald, Shirodkar or both were 12, two and one, respectively. Tocolysis was continued to suppress the uterine contraction for at least 24 h postoperatively, and patients were observed for any pain, contraction or other complication. Prophylactic broad-spectrum antibiotics were administrated i.v. at least for 5 days. Postoperative regimens of tocolytic agents and antibiotics were determined by the attending physician based on each patient’s condition. The suture was removed at 36 weeks of gestation or whenever labor was established. After providing informed consent, 20 women, consisting of 10 with a visible amniotic sac and 10 with a protruding amniotic sac, refused emergency cerclage instead choosing expectant management (bedrest group). In this group, i.v. tocolytic and/or antibiotic therapy was administrated in addition to bedrest, although the decision as to whether to administrate the former was made on an individual basis according to physical findings and/or white blood cell (WBC)/ C-reactive protein (CRP) values. Patient backgrounds (age, parity, history of conization and/or preterm delivery, and admission on health check-up for pregnant women) and main outcomes (duration of pregnancy prolongation, rates of delivery after 32 and 28 gestational weeks) were compared between the two groups. Similar comparisons were performed between the visible and the protruding amniotic sac subgroups within each group. The duration of pregnancy prolongation was defined as the number of days from the day of the cerclage procedure until delivery in the cerclage group and as the number of days from admission until delivery in the bedrest group. The data are represented as medians (range) or frequencies (percentage). Microsoft Excel and SPSS were used for statistical analyses. We applied the Mann– Whitney U-test for determining continuous variables. Fisher’s exact tests were used to detect differences in categorical data by group. Statistical tests were considered significant at P < 0.05 and were two-tailed.
Results Of the 35 women, 15 underwent cervical cerclage and 20 were managed expectantly. Table 1 shows the
© 2013 The Authors Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology
Cerclage versus expectant management
Table 1 Comparison of maternal characteristics between the cerclage and bedrest groups
Age Multiparity Previous conization Previous premature delivery Visible amniotic sac Protruding amniotic sac Number of admissions on health check-up WBC count on admission (/μL) CRP on admission (mg/dL)
Cerclage group (n = 15)
Bedrest group (n = 20)
P-value
33 8 0 5 8 7 10 8 480 0.3
35.5 12 1 2 10 10 8 10 000 0.262
0.61 1.00 1.00 0.11 1.00 1.00 0.17 0.33 0.64
(27–42) (53.3%) (0%) (33.3%) (53.3%) (46.7%) (66.7%) (5 560–17 000) (0.1–3.536)
(30–42) (60.0%) (5.0%) (10.0%) (50.0%) (50.0%) (40.0%) (7 230–17 440) (0.066–0.918)
Continuous variables were compared using a non-parametric Mann–Whitney U-test and presented as median values (range). Categorical variables were compared using Fisher’s exact test and presented as numbers (%). CRP, C-reactive protein; WBC, white blood cell.
Table 2 Comparison of pregnancy outcomes between the cerclage and bedrest groups
Gestational age at cerclage (weeks) Prolongation of pregnancy (days) Gestational age at delivery (weeks) Premature delivery Extremely premature delivery Delivery after 28 weeks Delivery after 32 weeks Gestational age on admission (weeks) Temporarily discharged
Cerclage group (n = 15)
Bedrest group (n = 20)
P-value
22.6 44 32.4 12 3 10 10 22.4 6
12.5 26.0 20 16 4 2 23.4 0
