An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy
STOPPIT-2
1 other identifier
interventional
2,228
2 countries
57
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2014
CompletedFirst Posted
Study publicly available on registry
September 9, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedMarch 25, 2020
March 1, 2020
4.7 years
September 5, 2014
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth
Gestation at delivery
Delivery of the babies
Neonatal Outcomes
The investigators will collect a number of measures to ascertain neonatal well being.
within 4 weeks after expected date of delivery
Secondary Outcomes (3)
The profile of cervical length measurements in women with twin pregnancy in the UK
18-20 weeks gestation
Participant Satisfaction
36 weeks gestation
Health economics
18-20 weeks gestation until 4 weeks postnatal
Study Arms (2)
Standard Treatment
NO INTERVENTIONWomen will be allocated to standard treatment, currently this is no treatment.
Arabin pessary
ACTIVE COMPARATORThe 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.
Interventions
The Arabin pessary is CE-certified for preventing Spontaneous Preterm Birth (SPB) (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC) and is being used in this study as per the CE certification and manufacturer's guidance.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women unable to give written informed consent
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- NHS Lothiancollaborator
Study Sites (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, BL4 0JR, United Kingdom
Royal Preston Hospital
Preston, Lancashire, United Kingdom
Croydon hospital
Croydon, London, United Kingdom
Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
Edinburgh, Lothian, EH16 4SA, United Kingdom
Pinderfields Hospital
Wakefield, Mid Yorkshire, WF1 4DG, United Kingdom
Royal Victoria Hospital
Newcastle upon Tyne, North East, NE1 4LP, 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
George Eliot
Nuneaton, Warwickshire, CV10 7DJ, United Kingdom
Birmingham Womens Hospital
Birmingham, West Midlands, United Kingdom
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ, United Kingdom
Bradford Royal Infirmary
Bradford, Yorkshire, United Kingdom
Leeds University Hospital Trust
Leeds, Yorkshire, United Kingdom
Aberdeen Maternity Hospital
Aberdeen, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Lancashire Women's and Newborn Centre
Burnley, United Kingdom
Rosie Maternity Hospital
Cambridge, United Kingdom
Leighton Hospital
Crewe, United Kingdom
Royal Devon & Exeter
Exeter, United Kingdom
Queen Elizabeth Hospital
Gateshead, United Kingdom
Princess Royal Maternity Hospital
Glasgow, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Arrowe Park Hospital, Wirral
Liverpool, United Kingdom
Liverpool Women's Hospital
Liverpool, United Kingdom
Whiston Hospital
Liverpool, United Kingdom
St Johns Hospital
Livingston, United Kingdom
Homerton University Hospital NHS Foundation Trust
London, United Kingdom
Newham Hospital
London, United Kingdom
Queen Charlottes' 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
James Cook Hospital
Middlesbrough, United Kingdom
Norfolk and Norwich Hospital
Norwich, United Kingdom
City Hospital NUH NHS Trust
Nottingham, United Kingdom
Queens Medical Centre, NUH NHS Trust
Nottingham, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Jessop Wing, Sheffield Teaching Hospitals NHS FT
Sheffield, United Kingdom
Princess Anne Hospital
Southampton, United Kingdom
Royal Stoke University Hospital University Hospitals of North Midlands
Stoke, United Kingdom
Sunderland Royal Hospital
Sunderland, United Kingdom
Royal Cornwall
Truro, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Wrexham Maelor
Wrexham, United Kingdom
Related Publications (3)
Norman JE, Norrie J, MacLennan G, Cooper D, Whyte S, Chowdhry S, Cunningham-Burley S, Neilson AR, Mei XW, Smith JB, Shennan A, Robson SC, Thornton S, Kilby MD, Marlow N, Stock SJ, Bennett PR, Denton J. The Arabin pessary to prevent preterm birth in women with a twin pregnancy and a short cervix: the STOPPIT 2 RCT. Health Technol Assess. 2021 Jul;25(44):1-66. doi: 10.3310/hta25440.
PMID: 34219633DERIVEDNorman JE, Norrie J, MacLennan G, Cooper D, Whyte S, Chowdhry S, Cunningham-Burley S, Mei XW, Smith JBE, Shennan A, Robson SC, Thornton S, Kilby MD, Marlow N, Stock SJ, Bennett PR, Denton J; STOPPIT-2 collaborative group. Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2): An open-label randomised trial and updated meta-analysis. PLoS Med. 2021 Mar 29;18(3):e1003506. doi: 10.1371/journal.pmed.1003506. eCollection 2021 Mar.
PMID: 33780463DERIVEDNorman JE, Norrie J, Maclennan G, Cooper D, Whyte S, Cunningham Burley S, Smith JBE, Shennan A, Robson SC, Thornton S, Kilby MD, Marlow N, Stock SJ, Bennett PR, Denton J. Open randomised trial of the (Arabin) pessary to prevent preterm birth in twin pregnancy with health economics and acceptability: STOPPIT-2-a study protocol. BMJ Open. 2018 Dec 6;8(12):e026430. doi: 10.1136/bmjopen-2018-026430.
PMID: 30530477DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jane E Norman, MD
University of Edinburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2014
First Posted
September 9, 2014
Study Start
November 1, 2014
Primary Completion
July 31, 2019
Study Completion
October 31, 2019
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
to be confirmed