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
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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.
期刊介绍:
The American Journal of Obstetrics and Gynecology, known as "The Gray Journal," covers the entire spectrum of Obstetrics and Gynecology. It aims to publish original research (clinical and translational), reviews, opinions, video clips, podcasts, and interviews that contribute to understanding health and disease and have the potential to impact the practice of women's healthcare.
Focus Areas:
Diagnosis, Treatment, Prediction, and Prevention: The journal focuses on research related to the diagnosis, treatment, prediction, and prevention of obstetrical and gynecological disorders.
Biology of Reproduction: AJOG publishes work on the biology of reproduction, including studies on reproductive physiology and mechanisms of obstetrical and gynecological diseases.
Content Types:
Original Research: Clinical and translational research articles.
Reviews: Comprehensive reviews providing insights into various aspects of obstetrics and gynecology.
Opinions: Perspectives and opinions on important topics in the field.
Multimedia Content: Video clips, podcasts, and interviews.
Peer Review Process:
All submissions undergo a rigorous peer review process to ensure quality and relevance to the field of obstetrics and gynecology.