Condition category
Pregnancy and Childbirth
Date applied
05/11/2014
Date assigned
03/12/2014
Last edited
03/12/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 1850 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?
The study will run from October 2014 to November 2018.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Sonia Whyte
sonia.whyte@ed.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Sonia Whyte

ORCID ID

Contact details

Room S7129
Simpson Centre for Reproductive Health
Royal Infirmary
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Type

Scientific

Additional contact

Prof Jane E Norman

ORCID ID

http://orcid.org/0000-0001-6031-6953

Contact details

University of Edinburgh MRC Centre for Reproductive Health
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TY
United Kingdom
+ 44 (0)131 242 2694
jane.norman@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17820; HTA 13/04/22

Study information

Scientific title

An open randomised trial of the Arabin pessary to prevent preterm birth in twin pregnancy, with health economics and acceptability - STOPPIT-2

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://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=17820 and http://www.nets.nihr.ac.uk/projects/hta/130422

Ethics approval

South East Scotland 02, 14/SS/1031

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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 1850 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 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

Phase

Drug names

Primary outcome measures

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
3. Health economics using a questionnaire and data collected from medical notes; time frame: 18-20 weeks gestation until 4 weeks postnatal

Overall trial start date

30/10/2014

Overall trial end date

01/11/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 1850; UK Sample Size: 1850

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

Recruitment start date

01/04/2015

Recruitment end date

28/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Simpson Centre for Reproductive Health
Edinburgh
EH16 4SA
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

QMRI
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
-
ray.french@ed.ac.uk

Sponsor type

University/education

Website

Organisation

NHS Lothian (UK)

Sponsor details

Waverley Gate
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
-
R&DOffice@nhslothian.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

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).

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes