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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 : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Maternal-Infantil Vall d´Hebron Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Preterm Birth Dietary Supplement: Probiotic Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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 : March 16, 2022
Estimated Study Completion Date : March 16, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Probiotics group
Probiotic drug
 Dietary Supplement: Probiotic
Reduce preterm birth with this dietary supplement
Placebo Comparator: Control group
This group will receive placebo
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Intergroup neonatal morbidity [ Time Frame: First year of life of newborns ]
    To assess neonatal morbidity


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Threatened preterm labour: regular clinical and cardiotography-registered uterine dynamics, and cervical modifications (cervical shortening ≤ 25 mm between 24 and 29 weeks, and ≤ 15 mm between 30 and 34 weeks) according to our care protocol.
  • Single gestation.
  • Echographically-normal foetal morphology.
  • Minimum age 18 years.
  • Ability to understand informed consent.
  • Signed informed consent.

Exclusion criteria

  • Multiple gestations.
  • Pregnant women with diagnosis of chorioamnionitis.
  • Cervical dilation.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Maria Goya 934893085 maria.goya@vhir.org

Locations
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Spain
Hospital Vall d'Herbron Recruiting
Barcelona, Spain, 08036
Contact: Maria M Goya    934893185    mariagoya@mac.com   
Sponsors and Collaborators
Maternal-Infantil Vall d´Hebron Hospital
More Information
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Responsible Party: Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier: NCT03689166    
Other Study ID Numbers: PR(AMI)236/2016
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study will allow us to determine whether the use of probiotics in pregnant women with TPL is associated with an increased risk of PB. 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. Similarly, it will facilitate understanding of the pathophysiology of PB, influence of vaginal microbiota and the mechanism of action of probiotics.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maternal-Infantil Vall d´Hebron Hospital:
Probiotics
Preterm birth
Threatened preterm labour
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications