Effect of Probiotics on the Preterm Delivery Rate in Pregnant Women at High Risk for Preterm Birth (PROPEV)
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|ClinicalTrials.gov Identifier: NCT03689166|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Dietary Supplement: Probiotic Other: Placebo||Not Applicable|
- 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%.
- 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.
Prospective, randomised, longitudinal, prospective, double-blind study.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 RCT|
|Official Title:||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|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||October 23, 2020|
|Estimated Study Completion Date :||January 15, 2021|
Active Comparator: Probiotics group
Dietary Supplement: Probiotic
Reduce preterm birth with this dietary supplement
Placebo Comparator: Control group
This group will receive placebo
- 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)
- Preterm birth rate <34 weeks [ Time Frame: From 24 to 34 weeks ]To evaluate the percentage of preterm birth in each group (in days of gestation)
- Preterm birth rate <32 weeks [ Time Frame: From 24 to 32 weeks ]To evaluate the percentage of preterm birth in each group (in days of gestation)
- Preterm birth rate <30 weeks [ Time Frame: From 24 to 30 weeks ]To evaluate the percentage of preterm birth in each group (in days of gestation)
- Preterm birth rate <28 weeks [ Time Frame: From 24 to 38 weeks ]To evaluate the percentage of preterm birth in each group (in days of gestation)
- Intergroup neonatal morbidity [ Time Frame: First year of life of newborns ]To assess neonatal morbidity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689166
|Contact: Maria Goyafirstname.lastname@example.org|
|Hospital Vall d'Herbron||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Maria M Goya 934893185 email@example.com|