Abstract / Summary
Abstract Background Preterm birth is the most common cause of death in babies and children aged under five worldwide. Globally, 10% of births are preterm. In the peri-viable period (22–24 weeks), the risk of mortality and, in those that survive, the risk of disability is highest. Between 24 and 28 weeks of gestation, approximately 80% of preterm births are related to infection. Safely delaying birth by just a few days may substantially reduce the risk of mortality and long-term disability. We propose to use a novel point-of-care methodology with a precision-medicine approach to identify those presenting in threatened preterm labour (tPTL) who have infection, the causative organism and its antibiotic resistance profile, allowing us to give targeted antibiotics. Using this approach, we will test the hypothesis that targeted antibiotic treatment increases the latency to birth and may potentially improve neonatal outcome. Methods The objectives of this randomised controlled non-blinded trial are to assess the acceptability and feasibility of amniocentesis-guided personalised treatment in women with preterm prelabour rupture of membranes (PPROM) or tPTL with intact membranes. Patients with tPTL or PPROM with singleton pregnancies between 23 + 0 and 34 + 0 weeks and none of the exclusion criteria or an indication for immediate delivery will be approached to take part. Following written informed consent, patients will be randomised in a 1:1 ratio to either usual care or personalised care. Those in the personalised care arm will undergo amniocentesis, and the amniotic fluid will be analysed with a point-of-care IL-6 assay, BioFire assessment for microbial DNA, conventional culture and microscopy. Treatment will be determined based on the IL-6 and BioFire results. Participants will be followed up until birth, with maternal and neonatal outcomes recorded. Discussion Recruitment to the PROMPT study opened to recruitment in April 2024 and is ongoing. It is currently a single-site study, but the addition of other sites is in progress. Trial registration ClinicalTrials.gov registration number NCT04878978.