STOPPIT-2
Research type
Research Study
Full title
An open randomised trial of the Arabin pessary to prevent preterm birth in twin pregnancy, with health economics and acceptability – STOPPIT 2.
IRAS ID
159610
Contact name
Jane E Norman
Contact email
Sponsor organisation
ACCORD
Research summary
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.
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 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. 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.
REC name
South East Scotland REC 02
REC reference
14/SS/1031
Date of REC Opinion
29 Aug 2014
REC opinion
Further Information Favourable Opinion