NCT05968794 Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation
| NCT ID | NCT05968794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 238 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 238 participants in total. It began in 2023-05-15 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05968794 clinical trial?
This trial is open to female participants only, aged 16 Years or older, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05968794 currently recruiting?
Yes, NCT05968794 is actively recruiting participants. Contact the research team at TWINC@amsterdamumc.nl for enrollment information.
Where is the NCT05968794 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Bruges, Belgium, Genk, Belgium, Ghent, Belgium and 9 additional locations.
Who is sponsoring the NCT05968794 clinical trial?
NCT05968794 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 238 participants.