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.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of extreme preterm birth
Timeframe: <28 weeks of gestation
Trial details
NCT IDNCT05968794
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)