The effect of uterine entry technique on chorioamniotic membrane separation in fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome: protocol for a randomized controlled trial

Brian A Burnett; Jessian L Munoz; Rebecca M Johnson; Christian M Parobek; Luis E Delgadillo Chabolla; Cara Buskmiller; Roopali V Donepudi; Magdalena Sanz Cortes; Michael A Belfort; Ahmed A Nassr

doi:10.1186/s12884-025-08410-5

Research Methods · Study Design

The effect of uterine entry technique on chorioamniotic membrane separation in fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome: protocol for a randomized controlled trial

Burnett BA, Munoz JL, Johnson RM, Parobek CM, Delgadillo Chabolla LE, Buskmiller C, Donepudi RV, Sanz Cortes M, Belfort MA, Nassr AA

Published November 21, 2025 BMC pregnancy and childbirth, 25(1)

DOI 10.1186/s12884-025-08410-5 PMID 41272584 PMC PMC12639666

Abstract

Background

Chorioamniotic membrane separation (CAS) is a recognized complication of fetoscopic laser photocoagulation (FLP) for twin-to-twin transfusion syndrome (TTTS), associated with increased risks of preterm prelabor rupture of membranes (PPROM) and preterm birth (PTB). Although CAS is well described, its incidence and relationship to specific surgical techniques, particularly the method of uterine entry, are not well defined in the published literature. No randomized trials have evaluated whether entry technique influences the risk of CAS.

Methods

We present the protocol for a randomized controlled trial comparing sharp-trocar and Seldinger uterine entry techniques for FLP in TTTS diagnosed between 16 + 0 and 26 + 0 weeks of gestation. The primary outcome is CAS diagnosed intraoperatively or within 48 h postoperatively by ultrasound evaluation. Secondary outcomes include preterm birth, procedure-to-delivery latency, perinatal survival, and maternal complications. A total of 216 participants will be enrolled, analyses will be conducted on an intention-to-treat basis.

Discussion

This trial will provide the first randomized evidence on whether uterine entry technique affects the incidence of CAS and perinatal outcomes in TTTS, with the potential to guide surgical best practices in fetal therapy.

Trial Registration

February 17, 2025 at ClinicalTrials.gov, NCT06829901.

Topics

Research Methods › Study Design › Randomized Controlled Trials · Clinical Guidelines and Standards › Diagnostic Criteria and Classification › Staging and Classification Systems

Brian A Burnett, Jessian L Munoz, Rebecca M Johnson, Christian M Parobek, Luis E Delgadillo Chabolla, Cara Buskmiller, Roopali V Donepudi, Magdalena Sanz Cortes, Michael A Belfort, Ahmed A Nassr

B Burnett, J Munoz, Becky Johnson, R Johnson, C Parobek, L Chabolla, C Buskmiller, R Donepudi, M Cortes, Mike Belfort, M Belfort, A Nassr

PMID 41272584 41272584 DOI 10.1186/s12884-025-08410-5 10.1186/s12884-025-08410-5 Burnett et al. 2025, Burnett 2025

The effect of uterine entry technique on chorioamniotic membrane separation in fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome: protocol for a randomized controlled trial

Abstract

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