Status:
COMPLETED
An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
NHS Lothian
Conditions:
Twin Pregnancy With Antenatal Problem
Eligibility:
FEMALE
16-60 years
Phase:
NA
Brief Summary
This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.
Detailed Description
STOPPIT-2 is a multicentre open label randomised controlled trial of the Arabin pessary (CE marked Device) versus Standard treatment in women with twin pregnancy. The study is in two phases - a SCREEN...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
2228 Patients enrolled
Trial Details
Trial ID
NCT02235181
Start Date
November 1 2014
End Date
October 31 2019
Last Update
March 25 2020
Active Locations (57)
Enter a location and click search to find clinical trials sorted by distance.
1
UZ Leuven
Leuven, Belgium
2
Countess of Chester
Chester, Cheshire, United Kingdom
3
St Mary's Hospital
Manchester, Cheshire, United Kingdom
4
Chesterfield Royal Hospital
Chesterfield, Derbyshire, United Kingdom