The Effectiveness of Cerclage for the Reduction of Extreme Preterm Birth and Perinatal Mortality in Twin Pregnancies With a Short Cervix or Dilatation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 238
- Locations
- 13
- Primary Endpoint
- Rate of extreme preterm birth
Study Overview
Brief Summary
The goal of this clinical trial is to assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age.
The main question it aims to answer is: What is the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age?
Participants will be randomly assigned to the intervention (cerclage) or comparison (no cerclage) group.
Detailed Description
Rationale: In the Netherlands, 250 women with a twin pregnancy deliver at < 28 weeks per year, resulting in 157 perinatal deaths. A vaginal cerclage could be an effective surgical method to reduce cervical insufficiency and with that preterm birth, but the evidence regarding its effectiveness on extreme preterm birth and (long term) neonatal outcome is lacking.
Objective
To assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A vaginal cerclage is a minor and safe surgical procedure commonly performed in singleton pregnancies with a short cervix and a previous preterm birth in all the participating centers, thus there is experience in the participating hospitals. The results of this study will show whether a vaginal cerclage reduces extreme preterm birth in women with twin pregnancy and a short cervix, and its accompanying perinatal complications. If proven effective, the implementation of this intervention will have a huge impact on the lifelong health of these children and their families.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Participants and investigators will not be blinded for the intervention.
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women (> 16 years of age) with a twin pregnancy and:
- •an asymptomatic short cervix at routine ultrasound investigation (below 24 weeks of gestation) OR
- •cervical dilatation (below 24 weeks of gestation)
Exclusion Criteria
- •Women with a mono-amniotic twin pregnancy
- •Women with twin pregnancy in which one or both children are diagnosed with a major structural, congenital or chromosomal abnormality that is likely to influence the composite adverse neonatal outcome.
- •Women with dilatation of the cervix and signs of clinical intra-uterine infection, defined by the presence of fever ≥ 38 degrees Celsius.
- •Women with overt symptoms of preterm labour at time of measurement of short cervix (regular contractions, PPROM, recurrent blood loss).
- •Women with a placenta previa, defined as a placenta position covering the internal ostium of the cervix.
- •Women who do not master the Dutch of English language and therefore not able to give written consent
Arms & Interventions
Cerclage
A vaginal cerclage is a short and minor surgical procedure performed under general or regional anesthesia. An unabsorbable suture is placed around/through the cervix to close the cervical canal and to increase its firmness, in order to reduce cervical insufficiency.
Intervention: Vaginal cerclage (Procedure)
Standard care
The comparator will be standard treatment according to the current Dutch (NVOG) guideline from 2018, which is to not perform or offer an intervention such as vaginal cerclage. This is in line with the standard care in the participating hospitals in Belgium.
Outcomes
Primary Outcomes
Rate of extreme preterm birth
Time Frame: <28 weeks of gestation
Secondary Outcomes
- Number of neonates with bronchopulmonary dysplasia(Up to 3 months corrected age)
- Number of neonates with periventricular leucomalacia > grade 1(Up to 3 months corrected age)
- Number of neonates with intraventricular hemorrhage > grade 2(Up to 3 months corrected age)
- Days on ventilation support(Up to 3 months corrected age)
- Days in NICU(Up to 3 months corrected age)
- Rate of maternal outcomes(Up to 3 months corrected age)
- Rate of Premature rupture of membranes(Up to 42 weeks of pregnancy)
- Gestational age at delivery(At delivery)
- Rate of Preterm birth(<24, <32, <34 and <37 weeks)
- Adverse neonatal outcome(Up to 3 months corrected age)
- Number of neonates with necrotizing enterocolitis > stage 2(Up to 3 months corrected age)
- Number of neonates with proven sepsis(Up to 3 months corrected age)
- Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score(Up to 3 months corrected age)
- Number of neonates with retinopathy of prematurity > stage 2(Up to 3 months corrected age)
- Perinatal death(Up to 3 months corrected age)
Investigators
Martijn A. Oudijk, MD, PhD
Prof.dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)