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

March 24, 2020 updated by: University of Edinburgh

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven
  • United Kingdom
      • Aberdeen, United Kingdom
        • Aberdeen Maternity Hospital
      • Birmingham, United Kingdom
        • Birmingham Heartlands Hospital
      • Burnley, United Kingdom
        • Lancashire Women's and Newborn Centre
      • Cambridge, United Kingdom
        • Rosie Maternity Hospital
      • Crewe, United Kingdom
        • Leighton Hospital
      • Exeter, United Kingdom
        • Royal Devon & Exeter
      • Gateshead, United Kingdom
        • Queen Elizabeth Hospital
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital
      • Glasgow, United Kingdom
        • Princess Royal Maternity Hospital
      • Liverpool, United Kingdom
        • Liverpool Women's Hospital
      • Liverpool, United Kingdom
        • Arrowe Park Hospital, Wirral
      • Liverpool, United Kingdom
        • Whiston Hospital
      • Livingston, United Kingdom
        • St Johns Hospital
      • London, United Kingdom
        • Royal London Hospital
      • London, United Kingdom
        • Whipps Cross Hospital
      • London, United Kingdom
        • University College Hospital
      • London, United Kingdom
        • Newham Hospital
      • London, United Kingdom
        • Homerton University Hospital NHS Foundation Trust
      • London, United Kingdom
        • St Georges Hospital
      • London, United Kingdom
        • St Thomas Hospital
      • London, United Kingdom
        • Queen Charlottes' Hospital
      • London, United Kingdom
        • St. Mary's
      • Middlesborough, United Kingdom
        • James Cook Hospital
      • Norwich, United Kingdom
        • Norfolk and Norwich Hospital
      • Nottingham, United Kingdom
        • City Hospital NUH NHS Trust
      • Nottingham, United Kingdom
        • Queens Medical Centre, NUH NHS Trust
      • Salisbury, United Kingdom
        • Salisbury District Hospital
      • Sheffield, United Kingdom
        • Jessop Wing, Sheffield Teaching Hospitals NHS FT
      • Southampton, United Kingdom
        • Princess Anne Hospital
      • Stoke, United Kingdom
        • Royal Stoke University Hospital University Hospitals of North Midlands
      • Sunderland, United Kingdom
        • Sunderland Royal Hospital
      • Truro, United Kingdom
        • Royal Cornwall
      • Wolverhampton, United Kingdom
        • New Cross Hospital
      • Wrexham, United Kingdom
        • Wrexham Maelor
    • Cheshire
      • Chester, Cheshire, United Kingdom
        • Countess of Chester
      • Manchester, Cheshire, United Kingdom
        • St Mary's Hospital
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom
        • Chesterfield Royal Hospital
    • Devon
      • Plymouth, Devon, United Kingdom
        • Derriford Hospital
    • Dorset
      • Poole, Dorset, United Kingdom
        • Poole Hospital
    • Essex
      • Basildon, Essex, United Kingdom
        • Basildon Hospital
    • Greater London
      • Uxbridge, Greater London, United Kingdom
        • Hillingdon Hospital
    • Lancashire
      • Bolton, Lancashire, United Kingdom, BL4 0JR
        • Royal Bolton Hospital
      • Preston, Lancashire, United Kingdom
        • Royal Preston Hospital
    • London
      • Croydon, London, United Kingdom
        • Croydon hospital
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
    • Mid Yorkshire
      • Wakefield, Mid Yorkshire, United Kingdom, WF1 4DG
        • Pinderfields Hospital
    • North East
      • Newcastle Upon Tyne, North East, United Kingdom, NE1 4LP
        • Royal Victoria Hospital
    • Northumbria
      • Ashington, Northumbria, United Kingdom
        • Wansbeck General Hospital
      • North Shields, Northumbria, United Kingdom
        • North Tyneside General Hospital
    • Surrey
      • Carshalton, Surrey, United Kingdom
        • St Helier Hospital
      • Epsom, Surrey, United Kingdom
        • Epsom Hospital
    • Warwickshire
      • Nuneaton, Warwickshire, United Kingdom, CV10 7DJ
        • George Eliot
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Birmingham Womens Hospital
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Russells Hall Hospital
    • Yorkshire
      • Bradford, Yorkshire, United Kingdom
        • Bradford Royal Infirmary
      • Leeds, Yorkshire, United Kingdom
        • Leeds University Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Treatment
Women will be allocated to standard treatment, currently this is no treatment.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Investigators

  • Principal Investigator: Jane E Norman, MD, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

October 31, 2019

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOPPIT-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

to be confirmed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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