Nordic randomised trial on laparoscopic versus vaginal cerclage (NORACT): trial protocol for an international, multicentre, randomised controlled trial.

ABSTRACT:

Introduction

Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.

Methods and analysis

The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded intern

SUBMITTER: Hansen LK 

PROVIDER: S-EPMC12458708 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature