A stitch placed around the cervix in an emergency can save a pregnancy that would otherwise be lost. Some women between 16 and 28 weeks of pregnancy develop painless cervical dilation, exposing the fetal membranes and putting the pregnancy at immediate risk of miscarriage or extreme preterm birth. Surgeons can attempt an emergency cervical cerclage (ECC) — a stitch to close the cervix — but the procedure itself carries risks, including rupturing the membranes during insertion. It is not known whether the stitch reliably improves outcomes compared with managing the condition without it. This trial randomly assigns women with exposed, unruptured membranes to receive ECC or no stitch, and follows surviving children to age two to assess neurodevelopment and general health. If the stitch proves effective, it could become a standard rescue intervention in maternity units across the UK, preventing pregnancy loss and reducing the lifelong burden of extreme preterm birth. If it does not, clinicians can avoid an invasive procedure that offers no benefit.
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A randomised controlled trial with an embedded prospective observational cohort. Objectives • To determine if an emergency cervical cerclage (ECC) reduces pregnancy loss (miscarriage, termination of pregnancy, stillbirth or neonatal death within 7 days of delivery) in women who present with cervical dilatation sufficient to allow exposure of the unruptured, fetal membranes at or below the level of the external os between 16+0 and 27+6 weeks. • To follow up all surviving babies to 2 years of age to determine general health and medium term neurodevelopmental outcomes. • To determine the complication rates at ECC: • Including the number of women who suffer iatrogenic rupture of membranes during the procedure. • The rate of insertion failure in women allocated to have an ECC inserted. • To explore predictors of successful ECC placement such as magnitude of dilatation. Trial Design A randomised controlled, multicentre trial (RCT) with an internal pilot, a nested qualitative process evaluation and cost-effectiveness analysis. Following the internal pilot and nested qualitative evaluation a prospective observational cohort study was developed to run alongside the RCT. Participant Population and Sample Size Pregnant women presenting at 16+0 - 27+6 weeks, with premature cervical dilatation and exposed, unruptured fetal membranes will be invited to take part in a RCT of ECC vs no cervical cerclage. If the woman is not approached or declines participation in the RCT then participation in the consented observational cohort should be discussed. Setting: Maternity units within the UK. Sample size: Eligibility Criteria Inclusion Criteria: • Women 16 years of age or older • Cervical dilatation sufficient to allow exposure of the unruptured, fetal membranes at or below the level of the external os • Singleton pregnancy • Gestational age 16+0 to 27+6 weeks • Able to give informed written consent. Exclusion Criteria: • Contraindication to emergency cerclage as judged by the clinician • Cervical cerclage (vaginal or abdominal) inserted earlier in this pregnancy or in a previous pregnancy that remains in situ. • Gestational age Interventions Health technology being assessed: ECC +/- other usual adjuncts (e.g. progesterone/antibiotics/tocolytics) will be compared with no ECC +/- other usual adjuncts. The other adjuncts will be at the discretion of the clinical team caring for the women. Outcome Measures Primary obstetric outcome: Pregnancy loss (defined as miscarriage, termination of pregnancy, stillbirth or neonatal death within 7 days of birth). Secondary outcomes: Maternal and fetal health outcomes which includes the core outcome set for preterm birth. Two-year outcomes: Assessment of developmental attainment using the Parent Report of Children’s Abilities - Revised for preterm infants (PARCA-R). Parent questionnaires to collect data on specific diagnoses at 2 years e.g. cerebral palsy. Cost effectiveness evaluation: At birth and two years of age.
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