Effect of Probiotics on the Preterm Delivery Rate (< 37 Weeks) in Pregnant Women at High Risk for Preterm Birth (Pregnant Women With Threatened Preterm Labour): PROPEV TRIAL Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Preterm birth rate <37 weeks
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Preterm birth (PB) continues to be the main cause of perinatal morbidity and mortality, with emotional and economic consequences. Despite improvements in health, PB prevalence remains stable, possibly due to complex causes such as maternal age, stress, multiparity, etc. Shortening of the uterine cervix in early stages of gestation is a risk factor for PB. The presence of abnormal vaginal microbiota in the early stages of pregnancy is als a risk factor for PB. However, no studies have analysed the impact of probiotics (live microorganisms which, in adequate amounts, confer a health benefit on the host) on the PB in high-risk PB patients (pregnant women with threatened preterm delivery, i.e., uterine contractions and cervical shortening, with a 30% PB risk before 34 weeks, and 50% PB prior to 37 weeks (> 6-10% PB). Similarly, the effect of probiotics on vaginal flora dominated by lactic acid-producing bacteria could be analysed.
Detailed Description
Hypothesis * Pregnant women with threatened preterm labour (TPL) will present vaginal microbiome different from those without TPL. * Treatment with probiotics will modify the vaginal microbioma of pregnant women with TPL. * The PB rate before 37 weeks in pregnant women with TPL who have received probiotics since their diagnosis will be reduced by at least 30%. Goals * To correlate the use of probiotics of pregnant women with TPL with the PB rate before 37 weeks. * To ascertain the PB rate before 28, 30, 32 and 34 weeks in both groups. * To assess neonatal morbidity between both groups. Methods Prospective, randomised, longitudinal, prospective, double-blind study. Relevance This study will determine whether the use of probiotics in pregnant women with TPL is associated with a lower risk of PB before 37 weeks. If so, it would allow us to act on the tertiary prevention of PB and treatment of TPL, the main cause of perinatal morbidity and mortality in our setting. It will also facilitate understanding of the pathophysiology of PB, influence of vaginal microbiota and the mechanism of action of probiotics.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Preterm birth rate <37 weeks
Time Frame: From 24 to 37 weeks
To evaluate the percentage of preterm birth in each group (in days of gestation)
Secondary Outcomes
- Preterm birth rate <34 weeks(From 24 to 34 weeks)
- Intergroup neonatal morbidity(First year of life of newborns)
- Preterm birth rate <32 weeks(From 24 to 32 weeks)
- Preterm birth rate <30 weeks(From 24 to 30 weeks)
- Preterm birth rate <28 weeks(From 24 to 38 weeks)