An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy

Not Applicable

Completed

• Conditions: Twin Pregnancy With Antenatal Problem

• Registration Number: NCT02235181
• Lead Sponsor: University of Edinburgh

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 SCREENING phase, in which women with a short cervix (cervical length of ( less or equal to 35mm) will be identified, and a TREATMENT phase, in which women with a short cervix will be randomised to treatment with Arabin pessary or Standard treatment. Women will be seen in the antenatal clinic setting.

An internal pilot phase will take place, with ten interviews being conducted with pregnant women to explore the acceptability of proposed methods of recruitment, their information requirements, their views of the consent and randomisation processes, and the delivery of the intervention, including the screening component. The interviews will also explore their understanding and expectations of trial participation. The findings of this pilot phase will feed into the next phase of the trial and support the design of the interview guides for the main nested qualitative study.

This pilot phase is separate from the main study. Later on we will ask both women and healthcare professionals about their experiences of the study, via questionnaires and face-to-face interviews.

Study Timeline

• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-09
• Study Start: 2014-11-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-10-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2228

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neonatal Outcomes	within 4 weeks after expected date of delivery	The investigators will collect a number of measures to ascertain neonatal well being.
The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth	Delivery of the babies	Gestation at delivery

Secondary Outcome Measures

Name	Time	Method
Participant Satisfaction	36 weeks gestation	Acceptability questionnaire
Health economics	18-20 weeks gestation until 4 weeks postnatal	cumulative hospital costs
The profile of cervical length measurements in women with twin pregnancy in the UK	18-20 weeks gestation	Cervical length

Trial Locations

Locations (57)

UZ Leuven; 🇧🇪 Leuven, Belgium

Countess of Chester; 🇬🇧 Chester, Cheshire, United Kingdom

St Mary's Hospital; 🇬🇧 Manchester, Cheshire, United Kingdom

Chesterfield Royal Hospital; 🇬🇧 Chesterfield, Derbyshire, United Kingdom

Derriford Hospital; 🇬🇧 Plymouth, Devon, United Kingdom

Poole Hospital; 🇬🇧 Poole, Dorset, United Kingdom

Basildon hospital; 🇬🇧 Basildon, Essex, United Kingdom

Hillingdon Hospital; 🇬🇧 Uxbridge, Greater London, United Kingdom

Royal Bolton Hospital; 🇬🇧 Bolton, Lancashire, United Kingdom

Royal Preston Hospital; 🇬🇧 Preston, Lancashire, United Kingdom

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