An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy (NCT02235181) | Clinical Trial Compass
CompletedNot Applicable
An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy
Belgium, United Kingdom2,228 participantsStarted 2014-11-01
Plain-language summary
This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.
Who can participate
Age range16 Years – 60 Years
SexFEMALE
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Inclusion Criteria:
* Women presenting with twin pregnancy (monochorionic or dichorionic)
* Women with gestation established by scan at ≤16 weeks according to NICE guidelines.
* Women aged 16 years or older
* Women wishing to participate in both the SCREENING and RANDOMISATION phase of the study
Exclusion Criteria:
* Women unable to give written informed consent
* Women with known significant congenital structural or chromosomal fetal anomaly at the time of inclusion
* Women with existing or planned cervical cerclage in the current pregnancy
* Women who with existing or planned (prior to 20+6 weeks gestation) treatment for twin to twin transfusion syndrome in the current pregnancy
* Women with suspected or proven rupture of the fetal membranes at the time of recruitment
* Women with singleton pregnancy or higher order multiple pregnancies
* Women with known sensitivity, contraindication or intolerance to silicone
* Women involved in a clinical trial of an investigational medicinal product (CTIMP)
What they're measuring
1
The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth
Timeframe: Delivery of the babies
2
Neonatal Outcomes
Timeframe: within 4 weeks after expected date of delivery