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. Accurately predicting whether a woman will have a preterm delivery is notoriously challenging. Up to 80% of women who show signs of preterm labour remain pregnant after 7 days. Despite this, many women are given treatments aimed at preventing complications for their babies, should they be premature. This can be very costly and little is known about the effects for mothers and their babies if a preterm delivery does not take place. Fetal fibronectin (fFN) is a “glue-like” protein which attaches the amniotic sac (the fluid sac that contains and protects a fetus) to the lining of the womb. At the end of pregnancy, fFN begins to break down and can be detected in vaginal fluid. By measuring the concentration of fFN, it is possible to predict whether the baby is likely to arrive prematurely (quantitative foetal Fibronectin test). Generally, the result will either be positive (showing the fFN is present and so there is an increased chance of labour) or negative (where it is not present, ruling out the chance of labour). The aim of this study is to find out how accurate the quantitative foetal Fibronectin (qfFN) test is at predicting preterm delivery. The results are compared with two pre-term birth marker tests currently available in the NHS (Actim Partus and Partosure). Who can participate? Women who are showing signs of going into labour prematurely. What does the study involve? Women have a vaginal swab taken so that levels of quantitative fetal fibronectin can be measured. This will allow the researchers to predict the chance of the women delivering their babies prematurely over the next seven days. Two additional vaginal swabs are also taken for the Actim Partus and Partosure tests. Regular contact is kept with the women in the form of telephone interviews so that the number of women who have had a preterm delivery can be measured. What are the possible benefits and risks of participating? There are no direct benefits to women or their babies for participating in this study, although some women gain satisfaction from contributing research studies which will improve future care for women with preterm labour. There are very few risks from participation as qfFN is the most commonly used test for preterm labour, and it is considered to be safe. Knowledge of qfFN results may increase or decrease anxiety levels, and this will be assessed as part of the trial. Where is the study run from? Royal Infirmary of Edinburgh (lead centre) and three hospitals in England (UK). When is the study starting and how long is it expected to run for? December 2015 to May 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? 1. Ms Lisa Wotherspoon (Public) [email protected] 2. Dr Sarah Stock (Scientific) [email protected]

Critère d'inclusion

• Preterm labour

Liens

• ictrp
• isrctn