Synbiotics in Patients at RIsk fOr Preterm Birth

Launched by ZIEKENHUIS OOST-LIMBURG · Jul 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of synbiotics, which are a combination of beneficial bacteria (probiotics) and substances that help these bacteria grow (prebiotics), to see if they can help pregnant women who are at risk for preterm birth. Premature births can lead to serious health issues for newborns, so this study aims to find out if starting synbiotics early in pregnancy can help create a healthier vaginal environment, potentially reducing the risk of preterm delivery.

To participate in this trial, women must be 18 years or older, have a single baby on the way, and have a history of issues that could lead to preterm birth, such as having had a premature baby before. Participants will take either synbiotics or a placebo (a dummy treatment) during their pregnancy, and researchers will monitor how this affects their vaginal health and pregnancy duration. This study is currently recruiting participants, and those who are interested will need to provide consent before joining.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed written informed consent must be obtained before any study assessment is performed;
• • 2. 18 years of age or older;
• • 3. Singleton pregnancy;
• • 4. Pregnancy consultation between 8 and 10 weeks gestation.
• 5. At least one of the following risk factors for spontaneous preterm birth:
• • Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency
• • PPROM ≤36 weeks in previous pregnancy
• • Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks.
• Exclusion Criteria:
• • 1. Patients who are already using pro-, pre- or synbiotics and not willing to stop
• • 2. Multiple pregnancy
• • 3. Need for primary (type 1) cerclage
• • 4. Inflammatory bowel disease
• • 5. Known congenital uterine anomaly
• • 6. History of LLETZ conization