Extrait

Background and aims Raised blood sugar levels and gestational diabetes are common complications in pregnancy, particularly as overweight and obesity levels are increasing among women before entering pregnancy. Probiotics are food supplements containing beneficial bacteria and recent research has found that taking probiotics may help to control blood sugar levels in pregnant and non-pregnant women. The aim of our study is to investigate whether taking a daily probiotic supplement will reduce blood sugar levels among obese pregnant women and pregnant women with gestational diabetes mellitus (GDM). Who can participate? To take part in the study you need to be female and pregnant, have an early-pregnancy body mass index (BMI) between 30.0 and 39.9 Kg/m2 OR have received a new diagnosis of gestational diabetes (GDM) in your current pregnancy, be aged between 18 and 45 years, have a singleton pregnancy (not twins) What does the study involve? This study involves two separate parts - Part A and Part B. Part A involves obese pregnant women (early-pregnancy BMI between 30.0 and 39.9 Kg/m2). You will be asked to take either a daily probiotic or placebo (contains no proiotic) capsule from 24 to 28 weeks of your pregnancy. The capsules will be provided to you free of charge. At 24 weeks, before starting the capsules, you will have a fasting blood sample taken to measure your blood sugar levels. At the end of the 28 weeks when you finish the capsules, you will have another fasting blood sample taken. At this stage, you will also be tested for diabetes. For the test, you will be given a sugary drink and have your blood sugar levels measured every hour for three hours after taking the drink. If the test is positive for diabetes, you will be immediately referred to the diabetic team in the hospital for the remainder of your pregnancy care. If the test is negative for diabetes, you will continue with your routine antenatal care but will be screened again for diabetes at 34 weeks. As part of this study, you will also be asked to complete a lifestyle questionnaire and a food diary. The purpose of the food diary is to record all the foods and drinks you take over three days in your pregnancy. This will be explained to you by the research dietitian. At delivery, blood will be taken from your baby's cord and your baby will be weighed and measured. Part B of the study involves women who have recently received a new diagnosis of gestational diabetes. This diagnosis is usually made around 29-33 weeks into your pregnancy. You will be asked to take either a daily probiotic or placebo capsule from the time you are recruited until the end of your pregnancy. The capsules will be provided to you free of charge. Throughout this time, your blood sugar levels will be closely monitored by the researchers and the diabetes clinical staff, which is part of routine care for diabetic women in pregnancy. Before you begin taking the capsules and approximately four weeks after starting on them, fasting blood samples will be taken. As part of this study, you will also be asked to complete a food diary. The purpose of the food diary is to record all the foods and drinks you take over three days in your pregnancy. This will be explained to you by the research dietitian. At delivery, blood will be taken from your baby's cord and your baby will be weighed and measured. What are the possible benefits and risks of participating? If you participate in Part A of the study, you will receive dietary advice from a dietitian and will receive an extra scan of your baby at 34 weeks. Neither of these are part of the routine care for non-diabetic pregnant women in Ireland. If you participate in Part B of the study, you will also receive dietary advice from a dietitian and a scan of your baby at 34 weeks, although these are part of routine antenatal care for diabetic women. There are no risks associated with this study. Probiotics have repeatedly been shown to be completely safe to take during pregnancy, with no risks for mother or baby. Where is the study run from? The PIP Study is taking place in the National Maternity Hospital, Holles Street, Dublin 2, Ireland. When is the study starting and how long is it expected to run for? The study is starting in February-March 2012 and is expected to end by December 2013. Who is funding the study? The study is funded by the Ivo Drury Award and The National Maternity Hospital Medical Fund, Dublin, Ireland. Who is the main contact? Prof Fionnuala McAuliffe [email protected]

Critère d'inclusion

• Pregnancy, obesity, gestational diabetes mellitus

Liens

• ictrp
• isrctn