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

Sponsor
University of Edinburgh (Other)
Overall Status
Completed
CT.gov ID
NCT02235181
Collaborator
NHS Lothian (Other)
2,228
Enrollment
57
Locations
2
Arms
60
Actual Duration (Months)
39.1
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Arabin Cervical Pessary
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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)
Actual Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Oct 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth [Delivery of the babies]

    Gestation at delivery

  2. Neonatal Outcomes [within 4 weeks after expected date of delivery]

    The investigators will collect a number of measures to ascertain neonatal well being.

Secondary Outcome Measures

  1. The profile of cervical length measurements in women with twin pregnancy in the UK [18-20 weeks gestation]

    Cervical length

  2. Participant Satisfaction [36 weeks gestation]

    Acceptability questionnaire

  3. Health economics [18-20 weeks gestation until 4 weeks postnatal]

    cumulative hospital costs

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Leuven Leuven Belgium
2 Countess of Chester Chester Cheshire United Kingdom
3 St Mary's Hospital Manchester Cheshire United Kingdom
4 Chesterfield Royal Hospital Chesterfield Derbyshire United Kingdom
5 Derriford Hospital Plymouth Devon United Kingdom
6 Poole Hospital Poole Dorset United Kingdom
7 Basildon hospital Basildon Essex United Kingdom
8 Hillingdon Hospital Uxbridge Greater London United Kingdom
9 Royal Bolton Hospital Bolton Lancashire United Kingdom BL4 0JR
10 Royal Preston Hospital Preston Lancashire United Kingdom
11 Croydon hospital Croydon London United Kingdom
12 Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh Edinburgh Lothian United Kingdom EH16 4SA
13 Pinderfields Hospital Wakefield Mid Yorkshire United Kingdom WF1 4DG
14 Royal Victoria Hospital Newcastle Upon Tyne North East United Kingdom NE1 4LP
15 Wansbeck General Hospital Ashington Northumbria United Kingdom
16 North Tyneside General Hospital North Shields Northumbria United Kingdom
17 St Helier Hospital Carshalton Surrey United Kingdom
18 Epsom Hospital Epsom Surrey United Kingdom
19 George Eliot Nuneaton Warwickshire United Kingdom CV10 7DJ
20 Birmingham Womens Hospital Birmingham West Midlands United Kingdom
21 Russells Hall Hospital Dudley West Midlands United Kingdom DY1 2HQ
22 Bradford Royal Infirmary Bradford Yorkshire United Kingdom
23 Leeds University Hospital Trust Leeds Yorkshire United Kingdom
24 Aberdeen Maternity Hospital Aberdeen United Kingdom
25 Birmingham Heartlands Hospital Birmingham United Kingdom
26 Lancashire Women's and Newborn Centre Burnley United Kingdom
27 Rosie Maternity Hospital Cambridge United Kingdom
28 Leighton Hospital Crewe United Kingdom
29 Royal Devon & Exeter Exeter United Kingdom
30 Queen Elizabeth Hospital Gateshead United Kingdom
31 Princess Royal Maternity Hospital Glasgow United Kingdom
32 Queen Elizabeth University Hospital Glasgow United Kingdom
33 Arrowe Park Hospital, Wirral Liverpool United Kingdom
34 Liverpool Women's Hospital Liverpool United Kingdom
35 Whiston Hospital Liverpool United Kingdom
36 St Johns Hospital Livingston United Kingdom
37 Homerton University Hospital NHS Foundation Trust London United Kingdom
38 Newham Hospital London United Kingdom
39 Queen Charlottes' Hospital London United Kingdom
40 Royal London Hospital London United Kingdom
41 St Georges Hospital London United Kingdom
42 St Thomas Hospital London United Kingdom
43 St. Mary's London United Kingdom
44 University College Hospital London United Kingdom
45 Whipps Cross Hospital London United Kingdom
46 James Cook Hospital Middlesborough United Kingdom
47 Norfolk and Norwich Hospital Norwich United Kingdom
48 City Hospital NUH NHS Trust Nottingham United Kingdom
49 Queens Medical Centre, NUH NHS Trust Nottingham United Kingdom
50 Salisbury District Hospital Salisbury United Kingdom
51 Jessop Wing, Sheffield Teaching Hospitals NHS FT Sheffield United Kingdom
52 Princess Anne Hospital Southampton United Kingdom
53 Royal Stoke University Hospital University Hospitals of North Midlands Stoke United Kingdom
54 Sunderland Royal Hospital Sunderland United Kingdom
55 Royal Cornwall Truro United Kingdom
56 New Cross Hospital Wolverhampton United Kingdom
57 Wrexham Maelor Wrexham United Kingdom

Sponsors and Collaborators

  • University of Edinburgh
  • NHS Lothian

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT02235181
Other Study ID Numbers:
  • STOPPIT-2
First Posted:
Sep 9, 2014
Last Update Posted:
Mar 25, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by University of Edinburgh
Twin Pregnancy
Prevention of Preterm birth
Short Cervix
Arabin cervical pessary
Additional relevant MeSH terms:
Premature Birth

Study Results

No Results Posted as of Mar 25, 2020