Twin Pregnancy With Antenatal ProblemSTOPPIT-2NCT02235181
An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy
A study testing Arabin Cervical Pessary in people with Twin Pregnancy With Antenatal Problem, run by University of Edinburgh at 57 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 years, women only
- Conditions the study is for
- Twin Pregnancy With Antenatal Problem
- What is being tested?
- Arabin Cervical Pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,228 participants
- Where
- 57 sitesin 2 countries
- Study dates
- 1 Nov 2014to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
United Kingdom56 sites
Aberdeen Maternity Hospital
Aberdeen
Wansbeck General Hospital
Ashington, Northumbria
Basildon hospital
Basildon, Essex
Birmingham Womens Hospital
Birmingham, West Midlands
Birmingham Heartlands Hospital
Birmingham
Royal Bolton Hospital
Bolton, Lancashire, BL4 0JR
Bradford Royal Infirmary
Bradford, Yorkshire
Lancashire Women's and Newborn Centre
Burnley
Rosie Maternity Hospital
Cambridge
St Helier Hospital
Carshalton, Surrey
Countess of Chester
Chester, Cheshire
Chesterfield Royal Hospital
Chesterfield, Derbyshire
Leighton Hospital
Crewe
Croydon hospital
Croydon, London
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ
Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
Edinburgh, Lothian, EH16 4SA
Epsom Hospital
Epsom, Surrey
Royal Devon & Exeter
Exeter
Queen Elizabeth Hospital
Gateshead
Princess Royal Maternity Hospital
Glasgow
Queen Elizabeth University Hospital
Glasgow
Leeds University Hospital Trust
Leeds, Yorkshire
Arrowe Park Hospital, Wirral
Liverpool
Liverpool Women's Hospital
Liverpool
Whiston Hospital
Liverpool
St Johns Hospital
Livingston
Homerton University Hospital NHS Foundation Trust
London
Newham Hospital
London
Queen Charlottes' Hospital
London
Royal London Hospital
London
St Georges Hospital
London
St Thomas Hospital
London
St. Mary's
London
University College Hospital
London
Whipps Cross Hospital
London
St Mary's Hospital
Manchester, Cheshire
James Cook Hospital
Middlesbrough
Royal Victoria Hospital
Newcastle upon Tyne, North East, NE1 4LP
North Tyneside General Hospital
North Shields, Northumbria
Norfolk and Norwich Hospital
Norwich
City Hospital NUH NHS Trust
Nottingham
Queens Medical Centre, NUH NHS Trust
Nottingham
George Eliot
Nuneaton, Warwickshire, CV10 7DJ
Derriford Hospital
Plymouth, Devon
Poole Hospital
Poole, Dorset
Royal Preston Hospital
Preston, Lancashire
Salisbury District Hospital
Salisbury
Jessop Wing, Sheffield Teaching Hospitals NHS FT
Sheffield
Princess Anne Hospital
Southampton
Royal Stoke University Hospital University Hospitals of North Midlands
Stoke
Sunderland Royal Hospital
Sunderland
Royal Cornwall
Truro
Hillingdon Hospital
Uxbridge, Greater London
Pinderfields Hospital
Wakefield, Mid Yorkshire, WF1 4DG
New Cross Hospital
Wolverhampton
Wrexham Maelor
Wrexham
About this study
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)
This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.
Read the 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.
- Conditions
- Twin Pregnancy With Antenatal Problem
- Being tested
- Arabin Cervical Pessary
- Keywords
- Twin Pregnancy, Prevention of Preterm birth, Short Cervix, Arabin cervical pessary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabin Cervical PessaryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | No intervention | Women will be allocated to standard treatment, currently this is no treatment. |
| Arabin pessary | Active comparator | 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. Receives: Device: Arabin Cervical Pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth
Gestation at delivery
Measured: Delivery of the babies
Neonatal Outcomes
The investigators will collect a number of measures to ascertain neonatal well being.
Measured: within 4 weeks after expected date of delivery
Secondary outcomes (3)
The profile of cervical length measurements in women with twin pregnancy in the UK
Cervical length
Measured: 18-20 weeks gestation
Participant Satisfaction
Acceptability questionnaire
Measured: 36 weeks gestation
Health economics
cumulative hospital costs
Measured: 18-20 weeks gestation until 4 weeks postnatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start1 Nov 2014
- Primary completion31 Jul 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Twin Pregnancy With Antenatal ProblemStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Jane E Norman, MD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235181
- Sponsor's protocol ID
- STOPPIT-2
- Acronym
- STOPPIT-2
- Status last verified
- Mar 2020
- First submitted
- 5 Sep 2014
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: to be confirmed
Publications
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.
PubMed 34219633Norman 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.
PubMed 33780463Norman 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.
PubMed 30530477
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02235181
- Acronym / sponsor ID
- STOPPIT-2 / STOPPIT-2
- Conditions
- Twin Pregnancy With Antenatal Problem
- Keywords
- Twin Pregnancy, Prevention of Preterm birth, Short Cervix, Arabin cervical pessary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,228 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | No intervention | –Women will be allocated to standard treatment, currently this is no treatment. |
| Arabin pessary | Active comparator | Device: Arabin Cervical PessaryThe 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. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arabin Cervical PessaryThe 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. | Device | Arabin pessary |
Primary outcome
The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth
Time frame: Delivery of the babies
Gestation at delivery
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.
3 secondary outcomes
The profile of cervical length measurements in women with twin pregnancy in the UK
Time frame: 18-20 weeks gestation
Participant Satisfaction
Time frame: 36 weeks gestation
Health economics
Time frame: 18-20 weeks gestation until 4 weeks postnatal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 34219633Norman 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.
- Derived from this study: PubMed 33780463Norman 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.
- Derived from this study: PubMed 30530477Norman 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.
- STOPPIT2 Study pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. to be confirmed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane E Norman, MD principal investigator
University of Edinburgh
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arabin Cervical Pessary in people with Twin Pregnancy With Antenatal Problem, run by University of Edinburgh at 57 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth (time frame: Delivery of the babies). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02235181, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.