ProPreB study
Probiotics for the Prevention of Preterm Birth
Objective
The objective of the ProPreB study is to screen pregnant women for abnormal vaginal flora and an abnormal pH level. Abnormal flora, bacterial vaginosis, and especially aerobic vaginitis are known risk factors for preterm birth, poor pregnancy outcomes, and miscarriage. All pregnant women up to 14 weeks of pregnancy can participate in the study, provided they meet the following criteria:
- No sexually transmitted infections at the time of inclusion.
- No vaginal bleeding or symptoms of vulvovaginitis.
- No use of systemic antibiotics, antimycotics, or progesterone in the past two weeks.
- No severe chronic conditions such as kidney failure (requiring dialysis), severe cardiovascular diseases (requiring treatment), or diabetes (requiring insulin).
Conditions that arise during pregnancy after inclusion, such as pre-eclampsia, do not constitute exclusion.
Research Question
The study investigates whether probiotics are effective in preventing preterm birth and compares vaginal flora and pregnancy outcomes between the intervention and control groups.
Intervention and Control
If the pregnant woman has abnormal flora and/or a pH level of 4.5 or higher, she may choose to take probiotics starting at 12 weeks of pregnancy. Women with normal flora or who do not agree to take probiotics will form the control group.