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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy in Woman With a Short Cervix (STOPPIT-2)

Conditions
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Twin Pregnancy With Antenatal Problem

Intervention / Treatment
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* Device: Arabin Cervical Pessary


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Treatment<br>Women will be allocated to standard treatment, currently this is no treatment. | |
| Active Comparator: Arabin pessary<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth | Gestation at delivery | Delivery of the babies | 
| Neonatal Outcomes | The investigators will collect a number of measures to ascertain neonatal well being. | within 4 weeks after expected date of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The profile of cervical length measurements in women with twin pregnancy in the UK | Cervical length | 18-20 weeks gestation | 
| Participant Satisfaction | Acceptability questionnaire | 36 weeks gestation | 
| Health economics | cumulative hospital costs | 18-20 weeks gestation until 4 weeks postnatal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Twin Pregnancy, Prevention of Preterm birth, Short Cervix, Arabin cervical pessary