Vaginal Probiotics for Premature Rupture of Membranes During Pregnancy

(PROBPROM-Pilot Trial)

No longer recruiting at 1 trial location

Overseen By Sarah Bilodeau

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must be taking: Vaginal probiotics

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Active labor, Infection, Malformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Variable, until delivery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether vaginal probiotics can influence the microbiota of babies born after a mother experiences premature rupture of membranes (water breaking early). Researchers will compare the microbiota in these babies to those born full-term. Participants in one group will take vaginal probiotics from the time their water breaks early until delivery. The trial seeks pregnant women who have experienced premature water breaking but not active labor, and who have not recently taken certain antibiotics or probiotics.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve outcomes for future pregnancies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain antibiotics or probiotics 15 days before joining. If you are in Group A, you should not have been treated with specific antibiotics during pregnancy.

What prior data suggests that vaginal probiotics are safe for pregnant women?

Research has shown that vaginal probiotics are usually safe for pregnant women. One study found that these probiotics might help delay childbirth and reduce the risk of complications when a woman's water breaks early, with no serious safety issues reported. Another study suggested that probiotics could help extend pregnancy by reducing infections.

Although some gaps in the data remain, probiotics are generally considered safe. Their use for other health issues further supports their safety. However, monitoring for any side effects and discussing concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using vaginal probiotics for premature rupture of membranes (PPROM) during pregnancy because these probiotics may offer a natural way to support maternal health. Unlike standard treatments that often focus on managing infection risk with antibiotics, probiotics introduce beneficial bacteria that can help maintain or restore a healthy vaginal microbiome. This approach could reduce complications associated with PPROM by promoting a balanced microbial environment, potentially lowering infection risk and improving outcomes for both mother and baby. The unique delivery method of probiotics directly to the site of action is also a promising development in pregnancy care.

What evidence suggests that vaginal probiotics might be an effective treatment for premature rupture of membranes?

Research has shown that vaginal probiotics might help when the water breaks too early during pregnancy, a condition known as premature rupture of membranes (PPROM). In this trial, some participants will receive vaginal probiotics to evaluate their effectiveness. Studies have found that these probiotics can delay childbirth and improve health for both mother and baby. For instance, probiotics significantly lower the risk of early birth. Some research even suggests that combining probiotics with antibiotics can enhance these positive effects. Overall, early findings suggest that vaginal probiotics may improve pregnancy outcomes and help manage PPROM. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant women who've experienced premature rupture of membranes, leading to the risk of preterm birth. Participants will use vaginal probiotics from the time their waters break until delivery and keep a diary of symptoms.

Exclusion Criteria

Signs of fetal distress (Groups A and B)

Presence of active labor (Groups A and B)

Vaginal probiotics intake 15 days before study entry (Groups A and B)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take vaginal probiotics from premature rupture of membranes until delivery and keep a diary of symptoms and compliance

Variable, until delivery

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including sample collection from mothers and babies

30 days after delivery

Sample collection at birth and 7 days after birth

Extension

Long-term monitoring of mother and baby health issues and probiotics presence in samples

Up to 13 months

What Are the Treatments Tested in This Trial?

Interventions

• Vaginal Probiotics

Trial Overview The study tests if vaginal probiotics can influence the microbiota (community of microbes) in both mothers and their babies born after premature water breaking, compared to those without treatment.

How Is the Trial Designed?

Group I: Probiotics group Experimental Treatment 1 Intervention

Pregnant women admitted to one of the center participating in the essay for PPROM accepting vaginal probiotics intake and sample collection

Group II: Control group - PPROM Active Control 1 Intervention

Pregnant women admitted to one of the study's centers for PPROM without vaginal probiotics intake

Group III: Control group- Full Term Active Control 1 Intervention

Pregnant women with expected full-term deliveries, without vaginal probiotics intake

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Lallemand Health Solutions

Industry Sponsor

Trials

44

Recruited

4,100+

Founded

1934

Headquarters

Mirabel, Canada

Known For

Microbiome therapies

Top Products

Lacidofil, ProbioKid, Probio'Stick, IBacilluS+

Citations

1. scientificarchives.com scientificarchives.com/article/the-effects-of-vaginal-probiotic-administration-on-perinatal-outcomes-in-patients-with-premature-preterm-rupture-of-membrane

The Effects of Vaginal Probiotic Administration on Perinatal ... The results of this study showed that the administration of vaginal probiotics in PPROM patients may be effective in delaying childbirth and reducing neonatal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11644756/

Probiotics in the Prophylaxis of Premature Rupture of ... The results showed a significant reduction in the incidence of PROM and preterm birth in the probiotic group compared to the control group [17].

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211523007625

Vaginal probiotics as an adjunct to antibiotic prophylaxis in ... Conclusions. The combination of vaginal probiotics and antibiotic prophylaxis has been shown to effectively improve perinatal outcomes in women with PPROM.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06878443

Vaginal Probiotics During Pregnancy After Premature ... The goal of this clinical trial is to compare the microbiota of preterm babies born after premature breaking water with full-term babies microbiota.

5. tandfonline.com tandfonline.com/doi/abs/10.1080/01443615.2022.2151349

Vaginal probiotics on the outcomes of premature rupture of ... We studied the effects of vaginal probiotics (Lactobacillus rhamnosus and L. gasseri) on the outcomes of PROM in pregnant women between 24 and 36 weeks of ...

6. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.70020

Management of preterm premature rupture of membranes ... Moreover, probiotics, amnioinfusion, and fetal membrane repair hold promise in alleviating infection-related inflammation and improving ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S258993332400048X

The effects of probiotics administration during pregnancy ... Low-certainty evidence suggests that probiotics make no difference to the primary outcomes, including preeclampsia and preterm birth <37 weeks' gestation.