Using cerclage to prevent extreme preterm birth in twin pregnancies with a short cervix

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a vaginal cerclage in preventing extreme preterm birth (before 28 weeks) in women with twin pregnancies who have a short cervix or cervical dilatation. Participants will be randomly assigned to receive either the cerclage intervention or standard treatment without cerclage. The study is motivated by the high incidence of extreme preterm births in twin pregnancies and seeks to provide evidence on whether cerclage can reduce these occurrences and improve neonatal outcomes. The trial will be conducted in multiple medical centers in the Netherlands, leveraging existing surgical expertise in the participating hospitals.

Why it matters

Who can join: the full rules

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

Where it's running

• University Medical Center Amsterdam
  Amsterdam, Netherlands Recruiting
• University Medical Center Antwerpen
  Antwerp, Belgium Not yet recruiting
• University Medical Center Sint-Lucas Brugge
  Bruges, Belgium Not yet recruiting
• Hospital Oost-Limburg Genk
  Genk, Belgium Not yet recruiting
• University Medical Center Gent
  Ghent, Belgium Not yet recruiting
• University Medical Center Leuven
  Leuven, Belgium Not yet recruiting

Study contacts

• Study coordinator: Lissa van gils, MD
• Email: TWINC@amsterdamumc.nl
• Phone: +31642811240

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.