Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes (C-STICH)

Birmingham Women’s Hospital0 sites2,051 target enrollmentDecember 3, 2014

Overview

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34583760/ protocol (added 30/09/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36273481/ (added 24/10/2022)

Registry

who.int

Start Date

December 3, 2014

End Date

July 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

Female

Sponsor

Birmingham Women’s Hospital

•1\. Singleton pregnancy
•2\. Indication for cervical cerclage (any of the below):
•2\.1\. A history of three or more previous midterm losses or premature births (\= 28 weeks)
•2\.2\. Insertion of cervical sutures in previous pregnancies
•2\.3\. A history of midtrimester loss or premature birth with a shortened (\= 25 mm) cervix
•2\.4\. Women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan and in whom the placement of a cervical cerclage is considered the most appropriate treatment
•3\. Aged 18 and over

•Current exclusion criteria as of 07/06/2017:
•1\. Women who have taken part in C\-STICH previously
•2\. Women aged less than 18 years old at the time of presentation
•3\. Those with a multiple pregnancy
•4\. Those requiring a rescue cerclage\*
•5\. Women who are unwilling or unable to give informed consent
•6\. Those in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route)
•7\. Immediate need for insertion of a suture\*\*
•8\. Women who have membranes that have ruptured or are surfacing\*\*\*
•\* For study purposes, rescue cerclage is defined as: emergency cerclage where stitches are inserted in women who have had their preterm labours (e.g. uterine contractions, progressive cervical dilatation, bulging membranes) sufficiently halted by tocolysis or other means between 15 and 28 weeks.