Abstract
BACKGROUND: Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and the potential benefits of cerclage are less certain. A randomised control trial is needed to accurately assess the effectiveness of ECC in preventing pregnancy loss compared to an expectant approach.
METHODS: C-STICH2 is a multicentre randomised controlled trial in which women presenting with cervical dilatation and unruptured exposed membranes at 16 + 0 to 27 + 6 weeks gestation are randomised to ECC or expectant management. Trial design includes 18 month internal pilot with embedded qualitative process evaluation, minimal data set and a within-trial health economic analysis. Inclusion criteria are ≥16 years, singleton pregnancy, exposed membranes at the external os, gestation 16 + 0-27 + 6 weeks, and informed consent. Exclusion criteria are contraindication to cerclage, cerclage in situ or previous cerclage in this pregnancy. Randomisation occurs via an online service in a 1:1 ratio, using a minimisation algorithm to reduce chance imbalances in key prognostic variables (site, gestation and dilatation). Primary outcome is pregnancy loss; a composite including miscarriage, termination of pregnancy and perinatal mortality defined as stillbirth and neonatal death in the first week of life. Secondary outcomes include all core outcomes for PTB. Two-year development outcomes will be assessed using general health and Parent Report of Children's Abilities-Revised (PARCA-R) questionnaires. Intended sample size is 260 participants (130 each arm) based on 60% rate of pregnancy loss in the expectant management arm and 40% in the ECC arm, with 90% power and alpha 0.05. Analysis will be by intention-to-treat.
DISCUSSION: To date there has been one small trial of ECC in 23 participants which included twin and singleton pregnancies. This small trial along with the largest observational study (n = 161) found ECC to prolong pregnancy duration and reduce deliveries before 34 weeks gestation. It is important to generate high quality evidence on the effectiveness of ECC in preventing pregnancy loss, and improve understanding of the prevalence of the condition and frequency of complications associated with ECC. An adequately powered RCT will provide the highest quality evidence regarding optimum care for these women and their babies.
TRIAL REGISTRATION: ISRCTN Registry ISRCTN12981869 . Registered on 13th June 2018.
| Original language | English |
|---|---|
| Article number | 529 |
| Number of pages | 11 |
| Journal | Trials |
| Volume | 22 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 11 Aug 2021 |
Bibliographical note
Funding Information:The authors wish to thank the women participating in this trial and staff at all sites. The following are members of the TSC (outside of the authorship of this paper) ? Professor Elizabeth Draper, Professor Carol Gamble, Dr Kenny McCormick, Professor Zarko Alfirevic, Jane Brewin and Ruth Bender Atik and DMC ? Professor Gordon Smith, Dr Richard Smith, Professor Graeme Maclennon. We thank the following organisations - Tommys, the PinksNBlues and the Miscarriage Association for their invaluable patient and public involvement contributions.
Funding Information:
The trial is funded by NIHR HTA (project number 16/151/01). The sponsor is Birmingham Women’s and Children’s NHS Foundation Trust. Neither the funder nor sponsor is involved in data collection or analysis.
Publisher Copyright:
© 2021, The Author(s).
Keywords
- Cervical cerclage
- Economic evaluation
- Miscarriage
- Preterm birth
- Qualitative process evaluation
- Randomised controlled trial
ASJC Scopus subject areas
- Medicine (miscellaneous)
- Pharmacology (medical)