Using cerclage to prevent extreme preterm birth in twin pregnancies with a short cervix
The Effectiveness of Cerclage for the Reduction of Extreme Preterm Birth and Perinatal Mortality in Twin Pregnancies With a Short Cervix or Dilatation
This study is testing if a special stitch called cerclage can help prevent extremely early births in women carrying twins who have a short cervix.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 238 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 13 sites (Antwerp and 12 other locations) |
| Trial ID | NCT05968794 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 16 years of age with a twin pregnancy and either a short cervix or cervical dilatation detected during routine ultrasound.
Not a fit: Patients with mono-amniotic twin pregnancies or those with significant fetal abnormalities or signs of preterm labor will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the rates of extreme preterm birth and improve the health outcomes for twins born to mothers with a short cervix.
How similar studies have performed: While the use of cerclage in singleton pregnancies has shown effectiveness, this approach in twin pregnancies is less established, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Antwerp and 12 other locations
- 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)
- University Medical Center Amsterdam — Amsterdam, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Not_yet_recruiting)
- University Medical Center Leiden — Leiden, Netherlands (Not_yet_recruiting)
- University Medical Center Maastricht — Maastricht, Netherlands (Not_yet_recruiting)
- Radboud University Medical Center — Nijmegen, Netherlands (Not_yet_recruiting)
- Erasmus Medical Centre — Rotterdam, Netherlands (Not_yet_recruiting)
- University Medical Center Utrecht — Utrecht, Netherlands (Not_yet_recruiting)
- Maxima Medical Centre — Veldhoven, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Lissa van gils, MD
- Email: TWINC@amsterdamumc.nl
- Phone: +31642811240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.