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Protocol for probiotic therapy vs placebo for preterm prelabour rupture of membranes to prolong pregnancy duration
Jonathan Sandeford1,2, Tanya Nippita1,2,3, Tushar Bhuta4
1Sydney Medical School Northern, The University of Sydney, Sydney, New South Wales, Australia.
Insights
This study investigates if oral probiotics can extend pregnancy in women with preterm prelabour rupture of membranes (PPROM). Probiotic use may prolong gestation and improve outcomes for preterm birth.
Area of Science:
- Obstetrics and Gynecology
- Neonatal Medicine
- Microbiome Research
Background:
- Preterm prelabour rupture of membranes (PPROM) is a significant cause of preterm birth, increasing risks for newborns.
- Infection is a known risk factor for early delivery in PPROM cases.
- Current management includes antibiotics, antenatal corticosteroids, and planned delivery, but probiotics show potential protective benefits.
Purpose of the Study:
- To assess if oral probiotic therapy (Lactobacillus fermentum CECT5716) prolongs pregnancy duration in women with PPROM between 24 and 34 weeks gestation.
- To evaluate the impact of probiotic therapy on maternal and neonatal outcomes.
Main Methods:
- A pragmatic, multicentre, double-blind, placebo-controlled randomised trial conducted in Australia.
- Participants: Women with singleton pregnancies experiencing PPROM before 34 weeks gestation.
- Intervention: Oral probiotic therapy versus placebo, with randomisation within 24 hours of PPROM. Primary outcome: Proportion of women pregnant at seven days post-PPROM.
Main Results:
- The trial is powered to detect a 30% absolute increase in the primary outcome (from 20% to 50%).
- Data on pregnancy duration and maternal/neonatal outcomes will be collected.
- Specific results are pending trial completion.
Conclusions:
- This trial will provide evidence on the efficacy of probiotics in extending pregnancy duration for PPROM.
- Findings will guide future larger trials on the clinical impact of oral probiotics for PPROM management.
Background:
Preterm prelabour rupture of membranes (PPROM) is a common preterm birth antecedent. Preterm infants experience increased adverse newborn outcome risks. Infection is a risk factor for early birth in PPROM. Current management is antibiotic therapy, antenatal corticosteroids and to plan delivery at 37 weeks gestation. The microbiota and probiotics are potentially protective and may improve outcomes.
Aims:
The primary aim is to evaluate whether oral probiotic therapy (Lactobacillus fermentum CECT5716) administered during PPROM between 24 and 34 weeks gestation prolongs pregnancy duration. The secondary aim is to evaluate maternal and neonatal outcomes.
Materials And Methods:
This is a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial in Australia. The population will be women with a singleton pregnancy and PPROM less than 34 weeks gestation. The intervention will be an oral probiotic therapy compared with a placebo control. The primary outcome will be the proportion of women still pregnant at seven days following PPROM. One-to-one randomisation will occur within 24 h of PPROM. The trial is powered (80%, alpha = 0.05) to detect an absolute percentage increase in the primary outcome of 30%, (from expected rate of 20% up to 50%).
Discussion:
This trial will provide evidence for the effectiveness of the probiotic in prolonging pregnancy duration. Findings will inform the feasibility of a larger trial to examine the effect of oral probiotics on clinically important maternal and neonatal outcomes in PPROM.
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