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

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Dietary Supplement: Probiotic; Other: Placebo

• Registration Number: NCT03689166
• Lead Sponsor: Maternal-Infantil Vall d´Hebron Hospital

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.

Study Timeline

• Study Start: 2017-10-23
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics group	Probiotic	Probiotic drug
Control group	Placebo	This group will receive placebo

Primary Outcome Measures

Name	Time	Method
Preterm birth rate <37 weeks	From 24 to 37 weeks	To evaluate the percentage of preterm birth in each group (in days of gestation)

Secondary Outcome Measures

Name	Time	Method
Preterm birth rate <32 weeks	From 24 to 32 weeks	To evaluate the percentage of preterm birth in each group (in days of gestation)
Preterm birth rate <30 weeks	From 24 to 30 weeks	To evaluate the percentage of preterm birth in each group (in days of gestation)
Preterm birth rate <28 weeks	From 24 to 38 weeks	To evaluate the percentage of preterm birth in each group (in days of gestation)
Preterm birth rate <34 weeks	From 24 to 34 weeks	To evaluate the percentage of preterm birth in each group (in days of gestation)
Intergroup neonatal morbidity	First year of life of newborns	To assess neonatal morbidity

Trial Locations

Locations (1)

Hospital Vall d'Herbron; 🇪🇸 Barcelona, Spain