Extrait

Background and study aims About 11% of all babies born worldwide are preterm (premature), meaning that they are born more than three weeks before their due date. The earlier babies are born, the more likely they are to die or develop long-term complications of brain, lung and gut development, particularly those born before 32 weeks. Prematurity is a huge emotional burden for families and communities, and a financial burden costing the public sector an extra £2.95 billion annually. Two-thirds of preterm births (PTB) happen spontaneously, the reason for which is unclear. Women who have previously had a PTB, have had important tissue removed from their cervix (neck of womb), or have a short cervix are more likely to give birth prematurely than the general population. There are currently three main treatments available which aim to help prolong pregnancy, preventing PTB: an arabin pessary, a cervical cerclage, or a vaginal progesterone pessary. It is currently not known which technique is the most effective. The aim of this study is to compare these treatments in a small study in order to find out whether it would be possible to later conduct a large-scale study. Who can participate? Women aged 18 and over who are between 16 and 24 weeks pregnant with a single baby, who are at risk of having a pre-term birth. What does the study involve? Participants are randomly allocated to receive one of three treatments: an arabin pessary (a silicone cup inserted vaginally to support the pregnancy), a cervical cerclage (a stitch placed surgically into the cervix), or a vaginal progesterone pessary (a vaginal tablet containing the hormone progesterone that is put in place by the patient every night). Patient and staff acceptability is measured 1-2 months after the end of the study, and the feasibility of recruiting participants for a large-scale study is assessed at 12 months after recruitment, along with an economic analysis. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? University of Liverpool (UK) When is the study starting and how long is it expected to run for? October 2015 to August 2017 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? 1. Dr Christine Cornforth (scientific) 2. Mrs Ediri O’Brien (public)

Critère d'inclusion

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

Liens

• ictrp
• isrctn