Status:
RECRUITING
Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Preterm Birth
Eligibility:
FEMALE
16+ years
Phase:
NA
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 c...
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 ce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT05968794
Start Date
May 15 2023
End Date
December 1 2028
Last Update
November 13 2023
Active Locations (13)
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1
University Medical Center Antwerpen
Antwerp, Belgium
2
University Medical Center Sint-Lucas Brugge
Bruges, Belgium
3
Hospital Oost-Limburg Genk
Genk, Belgium
4
University Medical Center Gent
Ghent, Belgium