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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jul 28, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a procedure called cerclage can help prevent extreme preterm birth (before 28 weeks of pregnancy) in women who are pregnant with twins and have a short cervix or have started to dilate (open) early. Cerclage involves placing a stitch around the cervix to help keep it closed. The trial compares the effectiveness of this treatment with standard care, which does not involve a cerclage.

To participate, women must be over 16 years old, pregnant with twins, and have either a short cervix or cervical dilatation without any signs of infection or other complications. Participants will be randomly assigned to either receive the cerclage or continue with standard treatment. The trial is currently recruiting, and it's important for participants to be able to understand the information provided, so knowledge of Dutch or English is necessary. This trial aims to find out if cerclage can make a difference in keeping twins in the womb longer and improving their health at birth.

Gender

FEMALE

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