Effect of Probiotics on the Preterm Delivery Rate in Pregnant Women at High Risk for Preterm Birth
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Preterm Birth
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Definition and design. Prospective, double-blind randomised study. Population Pregnant women admitted for TPL between weeks 24.0 and 34.6 of gestation at the participating centre.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blinded RCTPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 probiotic...
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.
Tracking Information
- NCT #
- NCT03689166
- Collaborators
- Not Provided
- Investigators
- Not Provided
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