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Completed

NCT Number: NCT03689166

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vall d'Herbron

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

Reduce preterm birth with this dietary supplement

Placebo

Other

Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maternal-Infantil Vall d´Hebron Hospital

Other

Registry information

Official study 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

Acronym: PROPEV

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 28, 2018
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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