Abstract
BackgroundCervical 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.MethodsC-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.DiscussionTo 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 registrationISRCTN Registry ISRCTN12981869. Registered on 13th June 2018.
Highlights
Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB)
It is important to generate high quality evidence on the effectiveness of Emergency cervical cerclage (ECC) in preventing pregnancy loss, and improve understanding of the prevalence of the condition and frequency of complications associated with ECC
The evidence for ECC was reviewed by NICE [11], which concluded that there may be benefit from ECC but that further evidence was required. In response to this we have designed C-STICH2 (Emergency Cervical Cerclage to Prevent Miscarriage and Preterm Birth), an open, multicentre randomised controlled trial to determine whether ECC improves maternal and infant outcomes in women who present with cervical dilatation and exposed unruptured foetal membranes, compared to routine expectant management
Summary
Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Stillbirth and delivery before 37 completed weeks of gestation are major contributors to pregnancy loss and the prevalence of significant morbidities among survivors following PTB at low gestational ages remains of concern, despite improving survival (BAPM Framework ADC 2019) These two conditions frequently share common aetiologies, namely cervical insufficiency and infection [14] and the management of women at risk of miscarriage or PTB remains broadly similar. In the second trimester a woman may present with a cervix that is already dilated exposing the foetal membranes In this situation an emergency cervical cerclage (ECC) or ‘rescue’ stitch can be attempted, with the intention of prolonging the pregnancy, preventing miscarriage or very early PTB, with the goal of improved neonatal outcomes [1]. There is risk of infection and potential harm to the mother or her baby, a risk of damage to the cervix and a risk of bleeding [10]
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