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Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation

RecruitingNAAges 16 Years - anyFemaleAcademisch Medisch Centrum - Universiteit van Ams…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Vaginal cerclage
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Where

13 sites
University Medical Center Antwerpen
Antwerp, Belgium
University Medical Center Sint-Lucas Brugge
Bruges, Belgium
Hospital Oost-Limburg Genk
Genk, Belgium
University Medical Center Gent
Ghent, Belgium
University Medical Center Leuven
Leuven, Belgium
University Medical Center Amsterdam
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
University Medical Center Leiden
Leiden, Netherlands

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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