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

Primary Purpose

Twin Pregnancy With Antenatal Problem

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Arabin Cervical Pessary
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Twin Pregnancy With Antenatal Problem focused on measuring Twin Pregnancy, Prevention of Preterm birth, Short Cervix, Arabin cervical pessary

Eligibility Criteria

16 Years - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • UZ Leuven
  • Countess of Chester
  • St Mary's Hospital
  • Chesterfield Royal Hospital
  • Derriford Hospital
  • Poole Hospital
  • Basildon hospital
  • Hillingdon Hospital
  • Royal Bolton Hospital
  • Royal Preston Hospital
  • Croydon hospital
  • Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
  • Pinderfields Hospital
  • Royal Victoria Hospital
  • Wansbeck General Hospital
  • North Tyneside General Hospital
  • St Helier Hospital
  • Epsom Hospital
  • George Eliot
  • Birmingham Womens Hospital
  • Russells Hall Hospital
  • Bradford Royal Infirmary
  • Leeds University Hospital Trust
  • Aberdeen Maternity Hospital
  • Birmingham Heartlands Hospital
  • Lancashire Women's and Newborn Centre
  • Rosie Maternity Hospital
  • Leighton Hospital
  • Royal Devon & Exeter
  • Queen Elizabeth Hospital
  • Princess Royal Maternity Hospital
  • Queen Elizabeth University Hospital
  • Arrowe Park Hospital, Wirral
  • Liverpool Women's Hospital
  • Whiston Hospital
  • St Johns Hospital
  • Homerton University Hospital NHS Foundation Trust
  • Newham Hospital
  • Queen Charlottes' Hospital
  • Royal London Hospital
  • St Georges Hospital
  • St Thomas Hospital
  • St. Mary's
  • University College Hospital
  • Whipps Cross Hospital
  • James Cook Hospital
  • Norfolk and Norwich Hospital
  • City Hospital NUH NHS Trust
  • Queens Medical Centre, NUH NHS Trust
  • Salisbury District Hospital
  • Jessop Wing, Sheffield Teaching Hospitals NHS FT
  • Princess Anne Hospital
  • Royal Stoke University Hospital University Hospitals of North Midlands
  • Sunderland Royal Hospital
  • Royal Cornwall
  • New Cross Hospital
  • Wrexham Maelor

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Treatment

Arabin pessary

Arm Description

Women will be allocated to standard treatment, currently this is no treatment.

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.

Outcomes

Primary Outcome Measures

The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth
Gestation at delivery
Neonatal Outcomes
The investigators will collect a number of measures to ascertain neonatal well being.

Secondary Outcome Measures

The profile of cervical length measurements in women with twin pregnancy in the UK
Cervical length
Participant Satisfaction
Acceptability questionnaire
Health economics
cumulative hospital costs

Full Information

First Posted
September 5, 2014
Last Updated
March 24, 2020
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT02235181
Brief Title
An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin Pregnancy With Antenatal Problem
Keywords
Twin Pregnancy, Prevention of Preterm birth, Short Cervix, Arabin cervical pessary

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment
Arm Type
No Intervention
Arm Description
Women will be allocated to standard treatment, currently this is no treatment.
Arm Title
Arabin pessary
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Arabin Cervical Pessary
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth
Description
Gestation at delivery
Time Frame
Delivery of the babies
Title
Neonatal Outcomes
Description
The investigators will collect a number of measures to ascertain neonatal well being.
Time Frame
within 4 weeks after expected date of delivery
Secondary Outcome Measure Information:
Title
The profile of cervical length measurements in women with twin pregnancy in the UK
Description
Cervical length
Time Frame
18-20 weeks gestation
Title
Participant Satisfaction
Description
Acceptability questionnaire
Time Frame
36 weeks gestation
Title
Health economics
Description
cumulative hospital costs
Time Frame
18-20 weeks gestation until 4 weeks postnatal

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane E Norman, MD
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Countess of Chester
City
Chester
State/Province
Cheshire
Country
United Kingdom
Facility Name
St Mary's Hospital
City
Manchester
State/Province
Cheshire
Country
United Kingdom
Facility Name
Chesterfield Royal Hospital
City
Chesterfield
State/Province
Derbyshire
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
Devon
Country
United Kingdom
Facility Name
Poole Hospital
City
Poole
State/Province
Dorset
Country
United Kingdom
Facility Name
Basildon hospital
City
Basildon
State/Province
Essex
Country
United Kingdom
Facility Name
Hillingdon Hospital
City
Uxbridge
State/Province
Greater London
Country
United Kingdom
Facility Name
Royal Bolton Hospital
City
Bolton
State/Province
Lancashire
ZIP/Postal Code
BL4 0JR
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
Lancashire
Country
United Kingdom
Facility Name
Croydon hospital
City
Croydon
State/Province
London
Country
United Kingdom
Facility Name
Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Pinderfields Hospital
City
Wakefield
State/Province
Mid Yorkshire
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Newcastle Upon Tyne
State/Province
North East
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Wansbeck General Hospital
City
Ashington
State/Province
Northumbria
Country
United Kingdom
Facility Name
North Tyneside General Hospital
City
North Shields
State/Province
Northumbria
Country
United Kingdom
Facility Name
St Helier Hospital
City
Carshalton
State/Province
Surrey
Country
United Kingdom
Facility Name
Epsom Hospital
City
Epsom
State/Province
Surrey
Country
United Kingdom
Facility Name
George Eliot
City
Nuneaton
State/Province
Warwickshire
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
Birmingham Womens Hospital
City
Birmingham
State/Province
West Midlands
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
State/Province
Yorkshire
Country
United Kingdom
Facility Name
Leeds University Hospital Trust
City
Leeds
State/Province
Yorkshire
Country
United Kingdom
Facility Name
Aberdeen Maternity Hospital
City
Aberdeen
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Lancashire Women's and Newborn Centre
City
Burnley
Country
United Kingdom
Facility Name
Rosie Maternity Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Leighton Hospital
City
Crewe
Country
United Kingdom
Facility Name
Royal Devon & Exeter
City
Exeter
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead
Country
United Kingdom
Facility Name
Princess Royal Maternity Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Arrowe Park Hospital, Wirral
City
Liverpool
Country
United Kingdom
Facility Name
Liverpool Women's Hospital
City
Liverpool
Country
United Kingdom
Facility Name
Whiston Hospital
City
Liverpool
Country
United Kingdom
Facility Name
St Johns Hospital
City
Livingston
Country
United Kingdom
Facility Name
Homerton University Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Newham Hospital
City
London
Country
United Kingdom
Facility Name
Queen Charlottes' Hospital
City
London
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
Country
United Kingdom
Facility Name
St Georges Hospital
City
London
Country
United Kingdom
Facility Name
St Thomas Hospital
City
London
Country
United Kingdom
Facility Name
St. Mary's
City
London
Country
United Kingdom
Facility Name
University College Hospital
City
London
Country
United Kingdom
Facility Name
Whipps Cross Hospital
City
London
Country
United Kingdom
Facility Name
James Cook Hospital
City
Middlesborough
Country
United Kingdom
Facility Name
Norfolk and Norwich Hospital
City
Norwich
Country
United Kingdom
Facility Name
City Hospital NUH NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
Queens Medical Centre, NUH NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
Country
United Kingdom
Facility Name
Jessop Wing, Sheffield Teaching Hospitals NHS FT
City
Sheffield
Country
United Kingdom
Facility Name
Princess Anne Hospital
City
Southampton
Country
United Kingdom
Facility Name
Royal Stoke University Hospital University Hospitals of North Midlands
City
Stoke
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
Country
United Kingdom
Facility Name
Royal Cornwall
City
Truro
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom
Facility Name
Wrexham Maelor
City
Wrexham
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
to be confirmed
Citations:
PubMed Identifier
34219633
Citation
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.
Results Reference
derived
PubMed Identifier
33780463
Citation
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.
Results Reference
derived
PubMed Identifier
30530477
Citation
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.
Results Reference
derived
Links:
URL
https://w3.abdn.ac.uk/hsru/STOPPIT2/
Description
STOPPIT2 Study page

Learn more about this trial

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

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