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

NCT05968794 · tracked via the Priya Life Science Belgium tracker

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Phase

Not applicable

Started

2023-05-15

Last updated

2023-11-13

Condition(s) studied

Preterm Birth

Investigational drug(s) / intervention(s)

Vaginal cerclage

Vaginal cerclage: A vaginal cerclage is a short and minor surgical procedure performed under general or regional anesthesia. An unabsorbable suture is placed around/through the cervix to close the cervical canal and to increase its firmness, in order to reduce cervical insufficiency.

Study 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

Sex

FEMALE

Min age

16 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Rate of extreme preterm birth — <28 weeks of gestation

Trial sites (13)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05968794 on ClinicalTrials.gov ↗ ← All trials in Belgium