Extrait

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 [email protected]

Critère d'inclusion

• Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth

Liens

• isrctn
• ictrp