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

NCT03689166 | Completed DMC

• 1 other identifier: PR(AMI)236/2016
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Probiotics; Preterm birth; Threatened preterm labour

Outcome Measures

Primary Outcomes (1)

• Preterm birth rate <37 weeks

  To evaluate the percentage of preterm birth in each group (in days of gestation)

  From 24 to 37 weeks

Secondary Outcomes (5)

• Preterm birth rate <34 weeks

  From 24 to 34 weeks

• Preterm birth rate <32 weeks

  From 24 to 32 weeks

• Preterm birth rate <30 weeks

  From 24 to 30 weeks

• Preterm birth rate <28 weeks

  From 24 to 38 weeks

• Intergroup neonatal morbidity

  First year of life of newborns

Study Arms (2)

Probiotics group

ACTIVE COMPARATOR

Probiotic drug

Dietary Supplement: Probiotic

Control group

PLACEBO COMPARATOR

This group will receive placebo

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Reduce preterm birth with this dietary supplement

Probiotics group

Placebo OTHER

Placebo

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Multiple gestations.
• Pregnant women with diagnosis of chorioamnionitis.
• Cervical dilation.

Sponsors & Collaborators

• Maternal-Infantil Vall d´Hebron Hospital: lead

Study Sites (1)

Hospital Vall d'Herbron

Barcelona, 08036, Spain

Location

Related Publications (1)

• Del Barco E, Molano LG, Vargas M, Miserachs M, Puerto L, Garrido-Gimenez C, Soler Z, Munoz B, Pratcorona L, Rimbaut S, Vidal M, Dalmau M, Casellas A, Carreras E, Manichanh C, Goya M. The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial). Biomedicines. 2025 May 8;13(5):1141. doi: 10.3390/biomedicines13051141.

  PMID: 40426968 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded RCT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: September 28, 2018
• Study Start: October 23, 2017
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)