None listed
Conditions
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
Sponsors
Study design
Eligibility
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