NORACT Nordic Randomized trial on laparoscopic versus vaginal cerclage
Research type
Research Study
Full title
Nordic randomized trial on laparoscopic versus vaginal cerclage Acronym: NORACT
IRAS ID
327906
Contact name
Lea Kirstine Hansen
Contact email
Sponsor organisation
Aarhus University Hospital
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Being born preterm is one of the leading causes of death in newborns and can lead to serious long-term health problems. Some women have a cervix that is weaker than usual, or may open early, which increases their risk of delivering their baby prematurely.
A cerclage, which is a supportive stitch placed around the cervix. Its purpose is to keep the cervix closed during pregnancy so the baby can continue to develop safely inside the womb, and prevent preterm birth. A helpful way to think about a cerclage is to imagine a bag with a drawstring: tightening the string helps keep the contents securely inside. In the same way, a cerclage supports the cervix and helps prevent it from opening too soon.
There are two established ways of placing a cerclage. A vaginal cerclage, where the stitch is placed through the vagina. The second is an abdominal cerclage, which can be placed using keyhole surgery through the abdomen. Both methods are already used in clinical practice, but we do not yet know which approach works best for women with a weakened cervix who are at high risk of preterm birth.
The NORACT trial has been designed to answer this important question. The study will directly compare the two surgical techniques to see which is more effective at preventing early birth. By increasing our understanding of the best type of cerclage for women with cervical weakness, the research aims to support better decision-making, improve pregnancy care, and ultimately reduce the number of babies born too soon.
Where the clinical team are unsure which operation is most suitable, they may invite patients to participate in this Randomised control trial.
Participants who consent to taking part will be randomly allocated to
1. Vaginal cerclage performed during pregnancy
or
2. Laparoscopic cerclage performed pre-pregnancy or until 10+0 weeks of gestation.REC name
West of Scotland REC 1
REC reference
25/WS/0187
Date of REC Opinion
27 Jan 2026
REC opinion
Further Information Favourable Opinion