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

Not Applicable

Completed

• Conditions: Insufficient cervix; Pregnancy and Childbirth

• Registration Number: ISRCTN15373349
• Lead Sponsor: Birmingham Women’s Hospital

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Study Completion: 2021-07-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2051

Inclusion Criteria

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

Exclusion Criteria

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.
** Immediate need for insertion of a suture should not be delayed by the trial (thus, if giving information about the trial and waiting for the participant to decide upon whether or not she wants to participate will delay the insertion of an urgently needed suture, then treatment should go ahead and the woman should be excluded from the trial).
***Woman with membranes that are ruptured or bulging through the external OS should have a rescue cerclage and be excluded from trial participation.

Previous exclusion criteria:
1. Women aged less than 16 years old at the time of presentation
2. Those with a multiple pregnancy
3. Those requiring a rescue cerclage
4. Women who are unwilling or unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified