Clinical trial NCT02235181: An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy
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
Overall status: COMPLETED
Phase: NA
Conditions: Twin Pregnancy With Antenatal Problem
Keywords: Twin Pregnancy
Prevention of Preterm birth
Short Cervix
Arabin cervical pessary
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2014-09-09
Enrollment: 2228
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth
timeFrame: Delivery of the babies
measure: Neonatal Outcomes
timeFrame: within 4 weeks after expected date of delivery
Secondary outcomes:
measure: The profile of cervical length measurements in women with twin pregnancy in the UK
timeFrame: 18-20 weeks gestation
measure: Participant Satisfaction
timeFrame: 36 weeks gestation
measure: Health economics
timeFrame: 18-20 weeks gestation until 4 weeks postnatal
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Chester
country: United Kingdom
facility: Countess of Chester
state: Cheshire
city: Manchester
country: United Kingdom
facility: St Mary's Hospital
state: Cheshire
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital
state: Derbyshire
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
city: Poole
country: United Kingdom
facility: Poole Hospital
state: Dorset
city: Basildon
country: United Kingdom
facility: Basildon hospital
state: Essex
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
state: Greater London
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
state: Lancashire
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: Lancashire
city: Croydon
country: United Kingdom
facility: Croydon hospital
state: London
city: Edinburgh
country: United Kingdom
facility: Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
state: Lothian
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital
state: Mid Yorkshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Hospital
state: North East
city: Ashington
country: United Kingdom
facility: Wansbeck General Hospital
state: Northumbria
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
state: Northumbria
city: Carshalton
country: United Kingdom
facility: St Helier Hospital
state: Surrey
city: Epsom
country: United Kingdom
facility: Epsom Hospital
state: Surrey
city: Nuneaton
country: United Kingdom
facility: George Eliot
state: Warwickshire
city: Birmingham
country: United Kingdom
facility: Birmingham Womens Hospital
state: West Midlands
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: West Midlands
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
state: Yorkshire
city: Leeds
country: United Kingdom
facility: Leeds University Hospital Trust
state: Yorkshire
city: Aberdeen
country: United Kingdom
facility: Aberdeen Maternity Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Burnley
country: United Kingdom
facility: Lancashire Women's and Newborn Centre
city: Cambridge
country: United Kingdom
facility: Rosie Maternity Hospital
city: Crewe
country: United Kingdom
facility: Leighton Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Glasgow
country: United Kingdom
facility: Princess Royal Maternity Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Liverpool
country: United Kingdom
facility: Arrowe Park Hospital, Wirral
city: Liverpool
country: United Kingdom
facility: Liverpool Women's Hospital
city: Liverpool
country: United Kingdom
facility: Whiston Hospital
city: Livingston
country: United Kingdom
facility: St Johns Hospital
city: London
country: United Kingdom
facility: Homerton University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Newham Hospital
city: London
country: United Kingdom
facility: Queen Charlottes' Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: St Georges Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
city: London
country: United Kingdom
facility: St. Mary's
city: London
country: United Kingdom
facility: University College Hospital
city: London
country: United Kingdom
facility: Whipps Cross Hospital
city: Middlesborough
country: United Kingdom
facility: James Cook Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Hospital
city: Nottingham
country: United Kingdom
facility: City Hospital NUH NHS Trust
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre, NUH NHS Trust
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Sheffield
country: United Kingdom
facility: Jessop Wing, Sheffield Teaching Hospitals NHS FT
city: Southampton
country: United Kingdom
facility: Princess Anne Hospital
city: Stoke
country: United Kingdom
facility: Royal Stoke University Hospital University Hospitals of North Midlands
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Wrexham
country: United Kingdom
facility: Wrexham Maelor
Study officials:
affiliation: University of Edinburgh
name: Jane E Norman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.