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 range

16 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth

Timeframe: Delivery of the babies

Neonatal Outcomes

Timeframe: within 4 weeks after expected date of delivery

Trial details

NCT IDNCT02235181

SponsorUniversity of Edinburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-31

View on ClinicalTrials.gov More Twin Pregnancy With Antenatal Problem trials