Effect of Probiotics on the Preterm Delivery Rate in Pregnant Women at

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03689166
Study type	Interventional
Source	Maternal-Infantil Vall d´Hebron Hospital
Contact
Status	Completed
Phase	N/A
Start date	October 23, 2017
Completion date	June 16, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Probiotics on the Preterm Delivery Rate in Pregnant Women at High Risk for Preterm Birth — PROPEV

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms