Physical examination–indicated cerclage in twin pregnancy: a randomized controlled trial

Roman, Amanda; Zork, Noelia; Haeri, Sina; Schoen, Corina N.; Saccone, Gabriele; Colihan, Sarah; Zelig, Craig M.; Gimovsky, Alexis C.; Seligman, Neil S.; Zullo, Fulvio; Berghella, Vincenzo

doi:10.1016/j.ajog.2020.06.047

Cited by 64 publications

(43 citation statements)

References 32 publications

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“…In multiple gestation with a normal or short cervix, interventions such as other forms of tocolytics, cerclage, progesterone, pessary, routine hospitalization, or bed rest have not been proven to prolong pregnancy or improve neonatal morbidity and mortality. 10,[28][29][30][31][32][33][34][35][36][37][38][39][40] In the setting of TTTS treated with FLS with short preoperative CL, cervical cerclage did not prolong pregnancy in a retrospective, multicenter cohort study. 41 Our study showed that LIT use significantly increased the FLS-to-delivery interval regardless of the length of the cervix and gestational age of the surgery.…”

Section: Discussionmentioning

confidence: 95%

Efficacy of Long Term Indomethacin Therapy in Prolonging Pregnancy After Fetoscopic Laser Surgery for Twin-to-Twin Transfusion Syndrome: a Collaborative Cohort Study

Mustafa

Krispin

Tadbiri

et al. 2021

Preprint

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Objective: To evaluate the efficacy of long-term indomethacin therapy (LIT) in prolonging pregnancy and reducing spontaneous preterm birth (PTB) in patients undergoing fetoscopic laser surgery (FLS) for the management of twin-to-twin transfusion syndrome (TTTS). Design: Retrospective cohort study of prospectively collected data. Setting: Collaborative multicenter study Population: 557 consecutive TTTS cases that underwent FLS Methods: LIT was defined as indomethacin use for at least 48 hours. Log-binomial regression was used to estimate the relative risk (RR) of PTB in LIT compared to non-LIT group. Cox regression was used to evaluate the association between LIT use and FLS-to-delivery survival. Main outcome measures: gestational age (GA) at delivery Results: Among the 411 pregnancies included, a total of 180 patients (43.8%) received LIT after FLS and 231 patients (56.2%) did not. Median GA at fetal intervention did not differ between groups (20.4 weeks). Median GA at delivery was significantly higher in the LIT group (33.6 weeks) compared to the non-LIT group (31.1weeks), p<0.001. FLS-to-delivery interval was significantly longer in the LIT group (P<0.001). The risk of PTB prior to 34, 32, 28, and 26 weeks gestation were all significantly lower in the LIT group compared to the non-LIT group (RR=0.69, 0.51, 0.37, and 0.18, respectively). The number needed to treat (NNT) with LIT to prevent one PTB<32 weeks gestation was 4, and to prevent one PTB<34 weeks was 5. Conclusion: Long-term indomethacin after FLS for TTTS was found to be associated with prolongation of pregnancy and reducing the risk for PTB.

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Section: Discussionmentioning

confidence: 95%

Efficacy of Long Term Indomethacin Therapy in Prolonging Pregnancy After Fetoscopic Laser Surgery for Twin-to-Twin Transfusion Syndrome: a Collaborative Cohort Study

Mustafa

Krispin

Tadbiri

et al. 2021

Preprint

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“…This is a multicenter, open-label RCT, inclusive of twin pregnancies at 16-26 weeks with symptomatic open cervix, randomized to cerclage or conservative management (https://clinicaltrials.gov/ct2/show/ NCT03818867). In 2020, a multicenter, parallel group, open-label, RCT of women with twin pregnancy and asymptomatic cervical dilation of 1-5 cm at 16 + 0 to 23 + 6 weeks, found that a combination of physical examination-indicated cerclage, indomethacin and antibiotics reduced the risk of preterm birth (50% reduction in extreme preterm birth < 28 weeks) as well as perinatal mortality (78% reduction) 108 . Despite this promising result, some argued that this trial does not provide a 'screening-and-prevention' approach.…”

Section: Screening Prevention and Management Of Preterm Birthmentioning

confidence: 99%

Controversies in the management of twin pregnancy

Khalil

Liu

2021

Ultrasound in Obstet & Gyne

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Despite many advances in antenatal care, twin pregnancies still experience more adverse outcomes, in particular higher perinatal mortality and morbidity. They also pose a multitude of challenges and controversies as outlined in this paper. Moreover, they are less likely to be included in clinical trials. Many issues on classification and management remain under debate. Efforts on standardising diagnostic criteria, monitoring protocols, management and outcome reporting are likely to reduce their perinatal risks. The top 10 most important research uncertainties related to multiple pregnancies have been identified by both clinicians and patients. More robust research in the form of randomised trials and large well-conducted prospective cohort studies are needed to address these controversies.

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“…12 Furthermore, this intervention resulted in a 50% reduction in preterm birth before 28 weeks of gestation (extreme preterm birth) and a 78% reduction in perinatal mortality. 12 Still, some would argue that this trial does not provide 'a screening and prevention' approach. However, recent evidence from a randomized, placebo-controlled, double-blind trial suggests that cervical-length assessment at 11-14 weeks' gestation, and administration of vaginal progesterone at a dose of 600 mg per day to those with a short cervix (<30mm), may reduce the risk of spontaneous preterm birth before 32 weeks.…”

Section: Key Findings and Recommendations Related To Preterm Birthmentioning

confidence: 99%

Key messages for obstetricians and fetal medicine specialists from the confidential enquiry into stillbirth and neonatal death in twins

Khalil

Reed²

2021

Ultrasound in Obstet & Gyne

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Physical examination–indicated cerclage in twin pregnancy: a randomized controlled trial

Cited by 64 publications

References 32 publications

Efficacy of Long Term Indomethacin Therapy in Prolonging Pregnancy After Fetoscopic Laser Surgery for Twin-to-Twin Transfusion Syndrome: a Collaborative Cohort Study

Efficacy of Long Term Indomethacin Therapy in Prolonging Pregnancy After Fetoscopic Laser Surgery for Twin-to-Twin Transfusion Syndrome: a Collaborative Cohort Study

Controversies in the management of twin pregnancy

Key messages for obstetricians and fetal medicine specialists from the confidential enquiry into stillbirth and neonatal death in twins

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