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

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. 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. 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. February 17, 2025 at ClinicalTrials.gov, NCT06829901.