An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy
- Conditions
- Twin Pregnancy With Antenatal Problem
- Interventions
- Device: Arabin Cervical Pessary
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2228
- 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
- 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
- Arm && Interventions
Group Intervention Description Arabin pessary Arabin Cervical Pessary The Arabin cervical pessary will be inserted between 18 and 20+6 days gestation and removed between 35 and 36+6 weeks gestation unless Labour occurs sooner.
- 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
Derriford Hospital
🇬🇧Plymouth, Devon, United Kingdom
Hillingdon Hospital
🇬🇧Uxbridge, Greater London, United Kingdom
Croydon hospital
🇬🇧Croydon, London, United Kingdom
Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
🇬🇧Edinburgh, Lothian, United Kingdom
Royal Victoria Hospital
🇬🇧Newcastle Upon Tyne, North East, United Kingdom
Pinderfields Hospital
🇬🇧Wakefield, Mid Yorkshire, United Kingdom
Wansbeck General Hospital
🇬🇧Ashington, Northumbria, United Kingdom
North Tyneside General Hospital
🇬🇧North Shields, Northumbria, United Kingdom
St Helier Hospital
🇬🇧Carshalton, Surrey, United Kingdom
Epsom Hospital
🇬🇧Epsom, Surrey, United Kingdom
Birmingham Womens Hospital
🇬🇧Birmingham, West Midlands, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, West Midlands, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, Yorkshire, United Kingdom
Leeds University Hospital Trust
🇬🇧Leeds, Yorkshire, United Kingdom
Aberdeen Maternity Hospital
🇬🇧Aberdeen, United Kingdom
Lancashire Women's and Newborn Centre
🇬🇧Burnley, United Kingdom
Rosie Maternity Hospital
🇬🇧Cambridge, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, United Kingdom
Princess Royal Maternity Hospital
🇬🇧Glasgow, United Kingdom
Leighton Hospital
🇬🇧Crewe, United Kingdom
Royal Devon & Exeter
🇬🇧Exeter, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Liverpool Women's Hospital
🇬🇧Liverpool, United Kingdom
Whiston Hospital
🇬🇧Liverpool, United Kingdom
Arrowe Park Hospital, Wirral
🇬🇧Liverpool, United Kingdom
St Johns Hospital
🇬🇧Livingston, United Kingdom
Queen Charlottes' Hospital
🇬🇧London, United Kingdom
Homerton University Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Newham Hospital
🇬🇧London, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
St Georges Hospital
🇬🇧London, United Kingdom
St Thomas Hospital
🇬🇧London, United Kingdom
St. Mary's
🇬🇧London, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Whipps Cross Hospital
🇬🇧London, United Kingdom
City Hospital NUH NHS Trust
🇬🇧Nottingham, United Kingdom
James Cook Hospital
🇬🇧Middlesborough, United Kingdom
Norfolk and Norwich Hospital
🇬🇧Norwich, United Kingdom
Queens Medical Centre, NUH NHS Trust
🇬🇧Nottingham, United Kingdom
Royal Stoke University Hospital University Hospitals of North Midlands
🇬🇧Stoke, United Kingdom
Jessop Wing, Sheffield Teaching Hospitals NHS FT
🇬🇧Sheffield, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, United Kingdom
Princess Anne Hospital
🇬🇧Southampton, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom
Royal Cornwall
🇬🇧Truro, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Wrexham Maelor
🇬🇧Wrexham, United Kingdom
Basildon hospital
🇬🇧Basildon, Essex, United Kingdom
Poole Hospital
🇬🇧Poole, Dorset, United Kingdom
St Mary's Hospital
🇬🇧Manchester, Cheshire, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Chesterfield Royal Hospital
🇬🇧Chesterfield, Derbyshire, United Kingdom
George Eliot
🇬🇧Nuneaton, Warwickshire, United Kingdom
Royal Preston Hospital
🇬🇧Preston, Lancashire, United Kingdom
Royal Bolton Hospital
🇬🇧Bolton, Lancashire, United Kingdom