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Cervical cerclage for singleton pregnant patients on vaginal progesterone with progressive cervical shortening

https://doi.org/10.1016/j.ajog.2018.06.020Get rights and content

Background

Premature cervical ripening plays a significant role in spontaneous preterm birth. Vaginal progesterone is the recommended treatment in singleton pregnancy with incidental short cervix. There is lack of evidence on whether it is beneficial to reinforce the cervix with cerclage when the cervical length becomes progressively shortened <10 mm while on vaginal progesterone.

Objective

Our aims are to determine whether cerclage with vaginal progesterone will: (1) reduce the overall spontaneous preterm birth rate, (2) prolong pregnancy latency, and (3) improve neonatal outcomes compared to vaginal progesterone alone.

Study Design

This was a retrospective cohort study at the University of Illinois at Chicago of all women with singleton pregnancy on vaginal progesterone for incidental short cervix, cervical length <20 mm. Only those with progressive cervical length shortening <10 mm who delivered at the University of Illinois at Chicago from January 2013 through December 2016 were included. The decision to perform cerclage was based on individual physician preference. Demographic data; information on serial cervical length status; medical, obstetric, and social history; cerclage vs no cerclage; and neonatal outcomes were compared.

Results

A total of 310 women with incidental short cervix on vaginal progesterone were identified, and of these, 75 had progressive shortening cervical length <10 mm and met inclusion criteria. Among the women with extremely shortened cervical length <10 mm, 36 women (48%) had cervical cerclage plus vaginal progesterone, and 39 women (52%) continued on vaginal progesterone alone. The baseline characteristics, mean cervical length (5.06 vs 5.52 mm), and mean gestational age at diagnosis of extreme short cervix (21.5 vs 21.3 weeks) were similar between women who received cerclage vs those who did not, respectively. The mean gestational age at delivery was significantly greater for those with cerclage (34 weeks and 3 days vs 27 weeks and 2 days; P < .001). The rate of spontaneous preterm birth at <37, 35, 32, 28, and 24 weeks were significantly lower in the cerclage group: 44.1% vs 84.2%, 38.2% vs 81.6%, 23.5% vs 78.9%, 14.7% vs 63.2%, and 11.8% vs 39.5%, respectively. The rate of spontaneous preterm birth <37 weeks remained significant after controlling for confounders (relative risk, 0.11; 95% confidence interval, 0.03–0.41; P < .001). The average pregnancy latency was 14 weeks in the cerclage combined with vaginal progesterone group compared to vaginal progesterone alone group. Neonatal intensive care unit admission and development of respiratory distress syndrome were significantly lower in the cerclage group compared to vaginal progesterone alone group: 13 (36.1%) vs 23 (65.7%) (relative risk, 0.55; 95% confidence interval, 0.34–0.90; P = .018) and 8 (22.2%) vs 17 (43.6%) (relative risk, 0.59; 95% confidence interval, 0.29–0.90; P = .027), respectively. Neonates of women with cerclage were also significantly less likely to develop necrotizing enterocolitis or experience neonatal death.

Conclusion

Our study showed that cerclage plus vaginal progesterone in women with extremely shortened cervix significantly decreased overall spontaneous preterm birth rates, prolonged pregnancy latency by 2-fold, and decreased the overall neonatal morbidity and mortality.

Introduction

Preterm birth (PTB) is the number one cause of neonatal morbidity and mortality worldwide, a leading cause of death among children <5 years of age, and responsible for long-term childhood disability in the United States.1, 2, 3 History of non-medically indicated preterm birth and short cervical length (CL) <25 mm in index pregnancy are strong predictors of spontaneous PTB (sPTB).4, 5, 6, 7 The role of increased uterine contractility has been the focus as the etiology of sPTB, but emerging evidence suggests that premature ripening of the uterine cervix plays a significant role.8, 9, 10 de Fonseca et al10, 11 first demonstrated the beneficial role of vaginal progesterone over placebo in the prevention of sPTB among women with short cervix in singleton pregnancy. Similarly, Hassan et al12 have shown in a large randomized trial that, in women with singleton gestation with no prior sPTB, who had shortened transvaginal ultrasound (TVUS) CL (10–20 mm), vaginal progesterone was associated with an approximately 45% reduction in sPTB <33 weeks. Multiple investigators have shown the beneficial effects of vaginal progesterone, and this has become the standard of care in women with singleton pregnancy and TVU CL <20 mm identified at midtrimester <24 weeks.10, 11

The meta-analysis of 5 high-quality randomized controlled trials by Romero et al13 supported the use of vaginal progesterone to prevent sPTB in women with short cervix. Moreover, Campbell14 in his editorial response to the above meta-analysis, emphasized the role of universal CL screening in midtrimester and use of vaginal progesterone for short cervix <25 mm.15 The Society for Maternal-Fetal Medicine,16 American Congress of Obstetricians and Gynecologists,17 and National Institute for Health and Care Excellence18 endorsed the practice of vaginal progesterone for short cervix but do not recommend universal CL screening, with the exception of the International Federation of Gynecology and Obstetrics, which endorses this practice.19

Cervical insufficiency is the inability of the uterine cervix to retain a pregnancy in the second trimester.20 Controversy exists regarding the pathophysiology, screening, diagnosis, and management of cervical insufficiency.20 A randomized controlled trial by Althuisius et al21 demonstrated the benefit of cerclage in patients with acute cervical insufficiency compared to observation. Owen et al4 studied women with prior sPTB with CL <25 mm and did not demonstrate a reduction in sPTB with cerclage, except in their secondary analysis of those with CL <15 mm. Contrarily, a randomized clinical trial did not find cerclage effective in reducing sPTB <33 weeks compared to controls with CL <15 mm.22 In the Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT)-1 and -2, Althuisius et al23, 24 demonstrated that cervical cerclage was significantly more effective than observation in reducing sPTB in women with history of midtrimester loss who develop short CL <25 mm. Berghella et al,25 in a systematic review and meta-analysis of randomized controlled trials, compared cervical cerclage with no cerclage in women with singleton gestation with CL <25 mm without prior PTB. They found no significant difference, but cerclage significantly reduced sPTB at CL <10 mm.25 The Romero et al13 meta-analysis provided persuasive evidence that vaginal progesterone reduces risk of sPTB and adverse perinatal outcomes in singleton pregnancy with short cervix <25 mm, regardless of history of sPTB; however, in this analysis, vaginal progesterone appeared not to have any effect when CL was <10 mm. The editorial on this meta-analysis by Oyelese et al26 suggests cerclage might be the optimal therapy for women with cervices <10 mm while vaginal progesterone would be ideal in women who have a CL between 10–25 mm.

Despite treatment with vaginal progesterone, there is lack of evidence on the clinical relevance of serial TVUS CL measurements in women already on vaginal progesterone who develop progressively short cervix. Moreover, insufficient evidence exists to assess if progesterone and cerclage together have additive effect in reducing the risk of sPTB.17 To our knowledge, there is no published literature on the effects of reinforcing the cervix with cerclage in women on vaginal progesterone when the CL becomes progressively shortened (<10 mm) despite treatment with vaginal progesterone. The aims of this study were to determine whether cervical cerclage in women who develop progressively shortened CL <10 mm, despite being on vaginal progesterone, would further reduce the overall sPTB rates, prolong pregnancy latency, and improve neonatal outcomes, when compared to vaginal progesterone alone.

Section snippets

Materials and Methods

A retrospective cohort study was conducted on women with singleton pregnancy with short CL on vaginal progesterone from Jan. 1, 2013, through Dec. 31, 2016 (University of Illinois at Chicago [UIC] institutional review board no. 2017-0627 approved). The UIC Medical Center offers universal TVU for all pregnant women during the fetal anatomical survey at midtrimester for CL measurement with an opt-out choice. All women with singleton gestation and no history of sPTB, diagnosed with incidental

Results

Of the 9679 live births during the study period at UIC, a total of 310 (3.2%) women with singleton pregnancy were diagnosed with incidental short cervix in the midtrimester and were treated with vaginal progesterone. All the women on vaginal progesterone underwent serial CL measurements every 1–2 weeks. Among these 310 women, 75 were diagnosed with progression to extreme short cervix <10 mm and they met inclusion criteria. Of these, 36 (48%) women had cervical cerclage in addition with

Principal findings

Our study showed cerclage decreased sPTB in singleton gestations with incidental short cervix, with no history of sPTB, that developed progressive CL shortening <10 mm despite being on vaginal progesterone. Cervical cerclage plus vaginal progesterone was effective in reducing sPTB at all GA studied, prolonged pregnancy latency, and improved perinatal outcomes. Because of lack of consensus in the medical literature, it is a challenging clinical dilemma to patients and physicians when, despite

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      Citation Excerpt :

      The incidence of SPTB <37 weeks was significantly increased in the group with progressive shortening of TVU CL (16% vs 8%, P=.03).8 A retrospective cohort of 310 women with singleton pregnancy without history of PTB and incidental TVU CL of 10–20 mm were offered vaginal progesterone and were followed up with additional TVU CL measurement in 1–2 weeks until 24 weeks.9 Among them, 75 (24.2%) had progressive shortening of the cervix to TVU CL <10 mm, and 23 (30%) were identified with cervical dilation before 24 weeks.

    View all citing articles on Scopus

    The authors report no conflict of interest.

    Cite this article as: Enakpene CA, DiGiovanni L, Jones TN, et al. Cervical cerclage for singleton pregnant patients on vaginal progesterone with progressive cervical shortening. Am J Obstet Gynecol 2018;219:397.e1-10.

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