The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial - 22/12/23

Doi : 10.1016/j.ajog.2023.11.1245

Carlota Rodo, MD, PhD ^a,^⁎ , Nerea Maiz, MD, PhD ^a,^⁎ , Silvia Arevalo, MD ^a, Liesbeth Lewi, MD, PhD ^b,^c, Isabel Couck, MD, PhD ^b, Bettina Hollwitz, MD ^d, Ioannis Kyvernitakis, MD ^e, Elena Carreras, MD, PhD ^a, Kurt Hecher, MD, PhD ^d
^a Maternal-Fetal Medicine Unit, Department of Obstetrics, Vall d’Hebron Institut de Recerca, Vall d’Hebron Hospital Universitari, Barcelona, Spain
^b Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium
^c Department of Development and Regeneration, Biomedical Sciences, Katholieke Universiteit Leuven, Leuven, Belgium
^d Department of Obstetrics and Fetal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
^e Department of Obstetrics and Prenatal Medicine, Asklepios Klinik Barmbek, Hamburg, Germany

^∗Corresponding authors: Carlota Rodo, MD, PhD.^∗Nerea Maiz, MD, PhD.

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Abstract

Background

Miscarriage and preterm birth are leading causes of loss and disability in monochorionic twins after laser treatment of twin-twin transfusion syndrome.

Objective

This study aimed to investigate the use of cervical pessary to reduce preterm birth before 32 weeks of gestation in monochorionic diamniotic twin pregnancies after fetal surgery for twin-twin transfusion syndrome.

Study Design

In this open-label multicenter randomized trial, pregnant women carrying monochorionic diamniotic twins requiring fetoscopic laser coagulation for twin-twin transfusion syndrome were randomly assigned in a 1:1 ratio to pessary placement or conservative management. The primary outcome was birth before 32 weeks of gestation. The secondary outcomes were birth before 28, 30, 34, or 37 weeks of gestation; preterm premature rupture of membranes; fetal and neonatal survival; and a composite of maternal and neonatal complications. The estimated sample size was 364 patients, with 182 cases in each arm of the study. The analysis was performed according to the intention-to-treat principle. Moreover, 2 interim analyses were planned.

Results

The trial was stopped prematurely after the first planned interim analysis for futility. Overall, 137 women were included in the analysis, 67 in the pessary group and 70 in the conservative management group. Preterm birth before 32 weeks of gestation occurred in 27 of 67 women (40.3%) in the pessary group and in 25 of 70 women (35.7%) in the conservative management group (adjusted odds ratio, 1.19; 95% confidence interval, 0.58–2.47; P=.63). No differences between groups were observed in the rate of deliveries before 28, 30, 34, and 37 weeks of gestation. Overall survival to delivery was 91.2% (125/137) for at least 1 twin, and 70.8% (97/137) for both twins, with no difference between groups. Neonatal survival at 30 days was 76.5% (208/272). There was no difference between the groups in maternal or neonatal morbidity.

Conclusion

In monochorionic diamniotic twin pregnancies requiring fetal therapy for twin-twin transfusion syndrome, routine use of cervical pessary did not reduce the rate of preterm birth before 32 weeks of gestation.

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Video

(11.56 Mo)Video 1Video 1.

Rodo. The pessary trial after laser for twin-twin transfusion syndrome. Am J Obstet Gynecol 2023.

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Key words : cervical pessary, fetoscopic laser coagulation, monochorionic pregnancy, preterm birth, spontaneous delivery

Plan

Introduction

Materials and Methods

Results in the context of what is known

Clinical implications

Research implications

Strengths and limitations

Conclusion

	The authors report no conflict of interest.
	No funding was obtained for the research. L.L. is the recipient of a grant of “Fonds voor Wetenschappelijk Onderzoek” (grant number: 1804718N).
	This study was registered on ClinicalTrials.gov (identifier: NCT01334489; NCT01334489?cond=pecep+laser&draw=2&rank=1). The date of registration was on April 13, 2011, and the date of initial participant enrollment was on January 4, 2012.
	Anonymized individual participant data that underlie the results will be available for individual patient meta-analyses within 24 months after trial publication. Data will be shared with investigators who have a project that has been approved by an independent ethics committee. Requests should be addressed to the corresponding author. The study protocol is published elsewhere.
	Cite this article as: Rodo C, Maiz N, Arevalo S, et al. The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial. Am J Obstet Gynecol 2023;XX:x.ex–x.ex.