Clinical Trial for the Prevention of Premature Birth and Neonatal Related Morbidity
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 645
- Locations
- 2
- Primary Endpoint
- Spontaneous premature birth (<37, <35, <32 weeks of pregnancy)
Study Overview
Brief Summary
The trial intends to evaluate the efficacy of specially designed probiotics to prevent premature birth and related neonatal morbidity associated to intra-uterine infection. The tested probiotics are efficacious to decrease the prevalence of bacterial vaginosis. The study hypothesis is that the early administration of those probiotics to pregnant women with bacterial vaginosis can prevent premature birth through antibiotic activity and modulation of the immune response to infection.
Detailed Description
The study is designed to be a randomized placebo-controlled double-blind trial that will screen asymptomatic low risk pregnant women without indication of elective premature birth admitted before the 20th week of pregnancy (Date of LMP and ultrasound) in prenatal care public services involved in the project in the city of Rio de Janeiro. Relevant prognostic factors will be registered: history of premature birth, race and low body index.
After clinical screening will be followed by a further screening process:
- vaginal pH exam will be determined by taking a swab and rolling it on a glass slide that will be touched by a pH stick . This procedure will immediately exclude patients with pH < 4,5 from the next step;
- The slides from patients with a vaginal pH > 4.4, will be Gram stained and interpreted according to the criteria of Nugent et al in order to select patients with BV or intermediate Nugent score (4-10). Patients with Nugent score below 4 will be excluded.
Pregnant women who are excluded from any of the above steps will be reassessed every 4 weeks, for new cases of BV/Intermediate score, during the next prenatal care visits, until they reach the 19th week.
BV/Intermediate patients will be randomized (centralized blocked randomization process), after signed informed consent, to receive either probiotics or placebo capsules twice a day (each capsule with probiotics shall contain > 1 million bacilli of each of 2 selected strains of lactobacillus: Lactobacillus rhamnosus GR1 and Lactobacillus reuteri RC-14).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Asymptomatic pregnant women with no indication of elective preterm delivery, before the 20th week of pregnancy
Exclusion Criteria
- •major malformations in present pregnancy
- •cervical cerclage
- •symptomatic vaginosis
- •insulin dependent diabetes
- •arterial hypertension
- •Multiple gestation
- •Antibiotic therapy in present pregnancy
- •Syphilis or gonorrhea in present pregnancy
- •asthma requiring chronic or intermittent therapy
- •corticotherapy(recent or chronic)
- •perinatal hemolytic disease
- •Systemic Erit. Lupus
Outcomes
Primary Outcomes
Spontaneous premature birth (<37, <35, <32 weeks of pregnancy)
Time Frame: 24 weeks
Secondary Outcomes
- and related neonatal events: early sepsis, bronchopulmonary dysplasia, cystic periventricular leukomalacia, ventricular hemorrhage and retinopathy, besides neonatal death.(28 weeks)
- Variation in Nugent Score (before/after intervention)(9 weeks)
- Variation in selected cytokine levels(before/after intervention)(9 weeks)