Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation (TWIN Cerclage)
Preterm Birth
About this trial
This is an interventional treatment trial for Preterm Birth focused on measuring Preterm birth, Twin pregnancy, Cerclage
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
Sites / Locations
- University Medical Center Antwerpen
- University Medical Center Sint-Lucas Brugge
- Hospital Oost-Limburg Genk
- University Medical Center Gent
- University Medical Center Leuven
- University Medical Center AmsterdamRecruiting
- University Medical Center Groningen
- University Medical Center Leiden
- University Medical Center Maastricht
- Radboud University Medical Center
- Erasmus Medical Centre
- University Medical Center Utrecht
- Maxima Medical Centre
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Cerclage
Standard care
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.
The comparator will be standard treatment according to the current Dutch (NVOG) guideline from 2018, which is to not perform or offer an intervention such as vaginal cerclage. This is in line with the standard care in the participating hospitals in Belgium.