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

Twin Pregnancy With Antenatal Problem Clinical Trial

— STOPPIT-2  

Official title:

An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy in Woman With a Short Cervix (STOPPIT-2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235181
• Other study ID #: STOPPIT-2
• Status: Completed
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2020
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.

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 information / eligibility

• Status: Completed
• Enrollment: 2228
• Est. completion date: October 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Twin Pregnancy With Antenatal Problem

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
United Kingdom	Aberdeen Maternity Hospital	Aberdeen
United Kingdom	Wansbeck General Hospital	Ashington	Northumbria
United Kingdom	Basildon hospital	Basildon	Essex
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Birmingham Womens Hospital	Birmingham	West Midlands
United Kingdom	Royal Bolton Hospital	Bolton	Lancashire
United Kingdom	Bradford Royal Infirmary	Bradford	Yorkshire
United Kingdom	Lancashire Women's and Newborn Centre	Burnley
United Kingdom	Rosie Maternity Hospital	Cambridge
United Kingdom	St Helier Hospital	Carshalton	Surrey
United Kingdom	Countess of Chester	Chester	Cheshire
United Kingdom	Chesterfield Royal Hospital	Chesterfield	Derbyshire
United Kingdom	Leighton Hospital	Crewe
United Kingdom	Croydon hospital	Croydon	London
United Kingdom	Russells Hall Hospital	Dudley	West Midlands
United Kingdom	Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh	Edinburgh	Lothian
United Kingdom	Epsom Hospital	Epsom	Surrey
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	Leeds University Hospital Trust	Leeds	Yorkshire
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	St Mary's Hospital	Manchester	Cheshire
United Kingdom	James Cook Hospital	Middlesborough
United Kingdom	Royal Victoria Hospital	Newcastle Upon Tyne	North East
United Kingdom	North Tyneside General Hospital	North Shields	Northumbria
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	George Eliot	Nuneaton	Warwickshire
United Kingdom	Derriford Hospital	Plymouth	Devon
United Kingdom	Poole Hospital	Poole	Dorset
United Kingdom	Royal Preston Hospital	Preston	Lancashire
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	Hillingdon Hospital	Uxbridge	Greater London
United Kingdom	Pinderfields Hospital	Wakefield	Mid Yorkshire
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	Wrexham Maelor	Wrexham

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth	Gestation at delivery	Delivery of the babies
Primary	Neonatal Outcomes	The investigators will collect a number of measures to ascertain neonatal well being.	within 4 weeks after expected date of delivery
Secondary	The profile of cervical length measurements in women with twin pregnancy in the UK	Cervical length	18-20 weeks gestation
Secondary	Participant Satisfaction	Acceptability questionnaire	36 weeks gestation
Secondary	Health economics	cumulative hospital costs	18-20 weeks gestation until 4 weeks postnatal

External Links

•   STOPPIT2 Study page