An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy
NCT ID: NCT02235181
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
2228 participants
INTERVENTIONAL
2014-11-01
2019-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
NCT02518594
The Trial of Pessary After Laser for TTTS
NCT01334489
Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix
NCT02357394
Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
NCT02849301
A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix
NCT02901626
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard Treatment
Women will be allocated to standard treatment, currently this is no treatment.
No interventions assigned to this group
Arabin 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.
Arabin Cervical Pessary
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Arabin Cervical Pessary
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
16 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NHS Lothian
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jane E Norman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Croydon hospital
Croydon, London, United Kingdom
Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
Edinburgh, Lothian, United Kingdom
Pinderfields Hospital
Wakefield, Mid Yorkshire, United Kingdom
Royal Victoria Hospital
Newcastle upon Tyne, North East, 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, 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
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Norman 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.
Norman 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.
Related Links
Access external resources that provide additional context or updates about the study.
STOPPIT2 Study page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STOPPIT-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.