Extrait

Background and study aims The chance that a woman will go into labour and deliver before 34 weeks is about 1%, but in women with a short cervix the chance of premature birth before 34 weeks increases to 4 to 40%. The majority of babies born prematurely survive and develop normally. However, babies born before 34 weeks have a higher chance of dying soon after birth or becoming disabled than babies born at term. There is some evidence that in singleton pregnancies with a previous premature birth or a short cervix, the chance of premature birth may be reduced by using progesterone or performing cervical cerclage. However, there is no single best effective intervention that has been proven to prolong pregnancy in women at risk, and some forms of treatment like cervical cerclage may even impose risk to the mother and fetus. There is some evidence that in women at risk of preterm delivery, the use of a vaginal pessary reduces the chance of premature birth, but the evidence is weak and therefore this issue needs further investigation. The aim of this study is to determine the effect of a vaginal pessary on the incidence of preterm delivery in women with a short cervix. Who can participate? Chinese women found to have a short cervix (less than 25 mm) with a singleton pregnancy. What does the study involve? You will be randomly allocated to one of two groups, either the expectant management group or the pessary group. Irrespective to which group you are allocated to, we will see you in our clinic every four weeks and carry out ultrasound scans to examine the baby and measure the length of your cervix. What are the possible benefits and risks of participating? Previous studies using the pessary have shown no adverse effects on the baby. A few women may experience increased vaginal discharge but the pessary does not cause a vaginal infection. During your visits to the hospital we will ask you if you have developed any vaginal discharge. If you have such a discharge we will examine you to find out if you have an infection and treat you with the necessary antibiotics. Where is the study run from? The study is conducted by Department of Obstetrics and Gynaecology at the Chinese University of Hong Kong. When is the study starting and how long is it expected to run for? The study ran from October 2008 to February 2011. Who is funding the study? The primary study site is at Prince of Wales Hospital, Hong Kong. Who is the main contact? Dr Annie Hui Tel: 2632 2211

Critère d'inclusion

• Cervical Insufficiency

Liens

• isrctn
• ictrp