A randomised trial in women with a twin pregnancy, using the Arabin pessary to prevent preterm birth – STOPPIT-2
| ISRCTN | ISRCTN98835694 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98835694 |
| ClinicalTrials.gov number | NCT02235181 |
| Secondary identifying numbers | 17820; HTA 13/04/22 |
- Submission date
- 05/11/2014
- Registration date
- 03/12/2014
- Last edited
- 06/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
This study aims to confirm whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix (neck of the womb). Preterm birth is associated with increased risk of death and ill health for the baby, so if preterm birth could be prevented in twins this would be a very good thing. The Arabin cervical pessary is used to reduce preterm birth in women with a singleton pregnancy (one baby). A Dutch study has suggested that the cervical pessary might also prevent preterm birth in twins. Although the pessary did not work in all twins, it appeared to reduce preterm birth in those women with a twin pregnancy who had a short cervix. The study aims to resolve uncertainty around whether the Arabin pessary reduces spontaneous preterm birth in twins and improves outcomes for babies, and whether women find the treatment acceptable. It will also calculate the costs for the NHS. We will look at the proportion of babies who are born before 34 weeks and the complications that happen to babies, and we will compare these between the two groups.
Who can participate?
Women aged 16 or older with a twin pregnancy, ≤16 weeks gestation
What does the study involve?
We will ask around 2500 women if they will have an ultrasound scan to measure their cervix usually around the same time as they have a fetal anomaly scan. Women who are in the lowest 30% of cervical length measurements (around 500) will be asked if they want to join the treatment phase of the study. Those who agree will be randomly allocated to be treated with either the Arabin pessary or standard treatment. The pessary will be inserted between the beginnings of the 18th to the end of the 20th week of pregnancy, and then removed at 36 weeks. We will collect information about women and their babies’ delivery details and well-being postnatally.
What are the possible benefits and risks of participating?
There is evidence that the Arabin pessary helps prevent preterm birth. However, we cannot promise the study will directly help you or your babies. The information we obtain from your participation in the study may help inform the future healthcare of other patients.
Where is the study run from?
Simpson Centre for Reproductive Health (UK)
When is the study starting and how long is it expected to run for?
October 2014 to July 2019
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Sonia Whyte
sonia.whyte@ed.ac.uk
Contact information
Scientific
Room S7129
Simpson Centre for Reproductive Health
Royal Infirmary
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Scientific
University of Edinburgh MRC Centre for Reproductive Health
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TY
United Kingdom
 ORCID ID |
0000-0001-6031-6953 |
|---|---|
| Phone | + 44 (0)131 242 2694 |
| jane.norman@ed.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | An open randomised trial of the Arabin pessary to prevent preterm birth in twin pregnancy, with health economics and acceptability - STOPPIT-2 |
| Study acronym | STOPPIT-2 |
| Study hypothesis | This study aims to confirm whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix. Preterm birth is associated with increased risk of death and ill health for the baby, so if preterm birth could be prevented in twins this would be a very good thing. The Arabin cervical pessary is used to reduce preterm birth in women with a singleton pregnancy (one baby). A Dutch study which finished late last year has suggested that the cervical pessary might also prevent preterm birth in twins. Although the pessary did not work in all twins, it appeared to reduce preterm birth in those women with a twin pregnancy who had a short cervix (neck of the womb). The study we propose here will resolve uncertainty around whether the Arabin pessary reduces spontaneous preterm birth in twins and improves outcomes for babies, define any adverse effects for mother and baby, ascertain whether women find the treatment acceptable and will calculate the costs for the NHS. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/130422 |
| Ethics approval(s) | South East Scotland 02, 14/SS/1031 |
| Condition | Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth |
| Intervention | In a large number of NHS centres, we will ask around 2500 women with a twin pregnancy if they will have an ultrasound scan to measure their cervix around the same time as they have a fetal anomaly scan. Women who are in the lowest 30% of cervical length measurements (around 500) will be asked if they want to join the treatment phase of the study. Those who agree will be treated with either the Arabin pessary or standard treatment. The pessary will be inserted between the beginning of the 18th to the end of the 20th week of pregnancy, and then removed at 36 weeks. The Arabin pessary will be inserted by a clinician who has completed the online training. We will look at the proportion of babies who are born before 34 weeks and the complications that happen to babies and we will compare these between the two groups. We will also perform an economic analysis to determine the cost-effectiveness of the Arabin pessary, and ask women about their experience of using the pessary. Cervical length will be measured by someone who has completed the Fetal Medicine Foundation or CLEAR accreditation for cervical length measurement. This will normally take place in the ultrasound department, often at the time of routine fetal anomaly scanning. |
| Intervention type | Other |
| Primary outcome measure | 1. Does the Arabin cervical pessary reduces spontaneous preterm labour (< 34 weeks) leading to preterm birth; time frame: delivery of the babies 2. Neonatal outcomes; time frame: within 4 weeks after expected date of delivery |
| Secondary outcome measures | 1. The profile of cervical length measurements in women with twin pregnancy in the UK; time frame: 18-20 weeks gestation 2. Participant satisfaction using a validated questionnaire; time frame: 36 weeks gestation - updated 06/04/2018: 30 and 36 weeks gestation 3. Health economics using a questionnaire and data collected from medical notes; time frame: 18-20 weeks gestation until 4 weeks postnatal |
| Overall study start date | 30/10/2014 |
| Overall study end date | 31/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 2500; UK Sample Size: 2500 |
| Total final enrolment | 2228 |
| Participant inclusion criteria | 1. Women presenting with twin pregnancy (monochorionic or dichorionic) 2. Women with gestation established by scan at ≤16 weeks according to NICE guidelines 3. Women aged 16 years or older 4. Women wishing to participate in both the screening and treatment phase of the study Target Gender: Female; Upper Age Limit 50 years; Lower Age Limit 16 years |
| Participant exclusion criteria | Screening phase: 1. Women unable to give written informed consent 2. Women with known significant congenital structural or chromosomal fetal anomaly at the time of inclusion 3. Women with existing or planned cervical cerclage in the current pregnancy 4. Women with existing or planned (prior to 20+6 weeks gestation) treatment for twin-to-twin transfusion syndrome in the current pregnancy 5. Women with suspected or proven rupture of the fetal membranes at the time of recruitment 6. Women with singleton pregnancy or higher order multiple pregnancies 7. Women with known sensitivity, contraindication or intolerance to silicone 8. Women involved in a clinical trial of an investigational medicinal product (CTIMP) Treatment phase: 1. Women with a cervical length > 30 mm at 18+0 20+6 weeks gestation - updated 06/04/2018: women with a cervical length > 35 mm at 18+0 20+6 weeks gestation |
| Recruitment start date | 01/04/2015 |
| Recruitment end date | 14/02/2019 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
EH16 4SA
United Kingdom
Sponsor information
University/education
QMRI
51 Little France Crescent
Edinburgh
EH16 4SA
Scotland
United Kingdom
| ray.french@ed.ac.uk | |
| Website | http://www.ed.ac.uk/home |
"ROR" |
https://ror.org/01nrxwf90 |
Hospital/treatment centre
Waverley Gate
2-4 Waterloo Place
Edinburgh
EH1 3EG
Scotland
United Kingdom
| R&DOffice@nhslothian.scot.nhs.uk | |
| Website | http://www.nhslothian.scot.nhs.uk/Pages/default.aspx |
|
"ROR" |
https://ror.org/03q82t418 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The current Protocol/SAP/PIS/Consent are available on the project website: https://w3.abdn.ac.uk/hsru/stoppit2/Public/DownloadPage.aspx The clinical study report will be used for publication and presentation at scientific meetings. The results of the study and any protocol deviations will be published in writing by a team headed by the Chief Investigator, which will report to the Trial Steering Committee. Individual investigators may be able to produce oral reports with the permission of the Project Management Group. Summaries of results will also be made available to Investigators for dissemination within their clinics (where appropriate and according to their discretion). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Professor Jane E Norman (Jane.Norman@ed.ac.uk). Anonymised data will be shared when it becomes available after study publication and for a least 5 years after the end of trial. Consent for use in future studies was obtained as per GDPR. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/12/2018 | Yes | No | |
| Abstract results | abstract | 01/01/2020 | 07/07/2020 | No | No |
| Results article | 29/03/2021 | 30/03/2021 | Yes | No | |
| Results article | 01/07/2021 | 06/07/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/07/2021: Publication reference added.
30/03/2021: Publication reference added.
16/07/2020: Internal review.
07/07/2020: Abstract added.
22/02/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2019 to 14/02/2019.
2. The overall trial end date was changed from 01/11/2019 to 31/07/2019.
3. The total final enrolment number was added.
17/12/2018: IPD sharing statement added.
12/12/2018: Publication reference added.
10/04/2018: Link to protocol, intention to publish date and IPD sharing statement added.
06/04/2018: The following changes were made to the trial record:
1. The target number of participants was changed from 1850 to 2500.
2. The recruitment end date was changed from 28/02/2018 to 28/02/2019.
3. The overall trial end date was changed from 01/11/2018 to 01/11/2019.
