Twin Pregnancy With Antenatal Problem
Conditions
Keywords
Twin Pregnancy, Prevention of Preterm birth, Short Cervix, Arabin cervical pessary
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.
Interventions
DEVICEArabin Cervical Pessary
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.
Sponsors
NHS Lothian
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Arabin cervical pessary reduces spontaneous preterm labour leading to preterm birth | Delivery of the babies | Gestation at delivery |
| Neonatal Outcomes | within 4 weeks after expected date of delivery | The investigators will collect a number of measures to ascertain neonatal well being. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The profile of cervical length measurements in women with twin pregnancy in the UK | 18-20 weeks gestation | Cervical length |
| Participant Satisfaction | 36 weeks gestation | Acceptability questionnaire |
| Health economics | 18-20 weeks gestation until 4 weeks postnatal | cumulative hospital costs |
Countries
Belgium, United Kingdom
Outcome results
None listed