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Protocol for probiotic therapy vs placebo for preterm prelabour rupture of membranes to prolong pregnancy duration (Pro-PPROM) trial.

  • 2021-01-23
  • The Australian & New Zealand journal of obstetrics & gynaecology 61(2)
    • Jonathan Sandeford
    • Tanya Nippita
    • Tushar Bhuta
    • Jillian Patterson
    • Jonathan Morris
    • Sean Seeho

Study Design

Type
Randomized Controlled Trial (RCT)
Population
women with a singleton pregnancy and PPROM less than 34 weeks gestation
Methods
pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial; oral probiotic therapy (Lactobacillus fermentum CECT5716) compared with placebo control
Blinding
Double-blind
Duration
seven days following PPROM
Funding
Unclear

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.

Research Insights

  • Lactobacillus fermentum CECT5716→Prolonged Pregnancy Duration

    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%).

    Effect
    Neutral
    Effect size
    Small
    Dose
    not stated
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