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Probiotics for rupture of the membranes to delay preterm birth (the Pro-PPROM trial)

Probiotics for women with preterm prelabour rupture of membranes (PPROM) to delay preterm birth: a randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000104358
Acronym
Pro-PPROM
Enrollment
78
Registered
2017-01-18
Start date
2017-03-01
Completion date
2018-12-30
Last updated
2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Preterm birth is a leading cause of death and long-term neurological disability for infants, with PPROM accounting for over one-third of preterm births. Apart from perinatal morbidity, there is also maternal morbidity from PPROM related to infection, such as chorioamnionitis. This trial aims to provide evidence demonstrating that probiotic therapy in women with PPROM prolongs pregnancy duration, thereby delaying preterm birth and improving neonatal outcomes. Delaying preterm birth will have a major impact on clinical practice and benefit the health of infants locally, nationally and internationally. New molecular techniques using DNA sequencing methods are increasing knowledge and understanding of the organisms and microbiome of women with PPROM and preterm birth. Biospecimens collected in the pilot trial aim to demonstrate the change in the intrauterine and neonatal microbiome to provide more information on the beneficial effects of probiotics for women at risk of preterm birth. This will build on the emerging medical literature on the changes in the intrauterine and vaginal biomes of the pregnant woman and the gastrointestinal biome of the baby associated with preterm birth, antibiotics and probiotics. The changes in the maternal and neonatal biome for women with PPROM may assist in understanding the causation of PPROM and preterm birth.

Interventions

1 sachet (13mg) of probiotic 'Qiara' (Lactobacillus fermentum CECT5716) dissolved in water/juice/milk twice daily for the duration of the pregnancy.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Pregnant women 2. Maternal age >18 3. Singleton pregnancy 4. PPROM defined as a history suggestive of spontaneous rupture of membranes followed by a sterile speculum examination demonstrating fluid pooling in the posterior fornix. 5. Gestational age less than 34 weeks 6. Ability to provide consent

Exclusion criteria

Maternal 1. Active chorioamnionitis 2. Patients in active labour 3. Multiple pregnancy 4. Hypertensive diseases of pregnancy Neonatal 1. Evidence of foetal compromise 2. Known significant structural/chromosomal fetal anomaly 3. Known lethal congenital/structural malformation 4. Intrauterine death

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026