C-STICH2 Randomised controlled trial of emergency cerclage
Research type
Research Study
Full title
C-Stich2: Emergency Cervical Cerclage to Prevent Miscarriage and Preterm Birth: a Randomised Controlled Trial
IRAS ID
239782
Contact name
R Katie Morris
Contact email
Sponsor organisation
Birmingham Womens and Childrens NHS Foundation Trust
ISRCTN Number
ISRCTN12981869
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
A cervical cerclage is the placement of a stitch to keep the neck of the womb closed. A stitch can be placed in a planned way because of a risk of preterm birth based on a woman’s pregnancy history or because the neck of the womb is shorter than normal on an ultrasound scan but still closed. Sometimes the neck of the womb can start to open and expose the bag of water around the baby. If this happens between 16 and 28 weeks of pregnancy, an emergency stitch is sometimes inserted to try to delay delivery. Prolonging the pregnancy so that the baby can be born when they are bigger and stronger may give them a better chance of surviving and suffering from fewer complications of prematurity. However, doctors do not know if an emergency cerclage works. There is some evidence it may prolong pregnancy but it is possible that it will also speed up delivery by causing infection or damage to the neck of the mother’s womb. It is therefore very important to undertake a study to decide if emergency cerclages delay delivery, and if they do, whether this benefits the baby (and mother). The best way to work out if emergency cerclage works, and is safe, is to ask women to be randomly allocated to either emergency cerclage or no cerclage. This is what we need to do to ensure we know what is best for future women and babies to prevent harm. This study will ask women who have an open neck of the womb with the bag of waters around the baby coming through, to have either an emergency stitch or no emergency stitch. Which treatment they will receive will be decided by a process that randomly allocates a woman to one group or the other. All women in the study, irrespective of their allocated group, will be able to have other treatments that may help prolong pregnancy such as antibiotics, progesterone and medicines that stop the womb contracting. The study team will collect information about what happens to the mother and baby from their medical notes and talk to women about their experiences of taking part in the study. Where appropriate families will be contacted at 2 years of age to assess how the babies are developing by a postal questionnaire completed by the carers.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0310
Date of REC Opinion
16 Nov 2018
REC opinion
Further Information Favourable Opinion