Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies

What this Trial Is About

Preterm delivery, defined as birth before 37 weeks of gestation, is a leading cause of infant mortality and affects millions of births worldwide each year. This research aims to clinically validate the predictive accuracy of the PrediMAP in-vitro diagnostic medical device, which is designed to predict delivery within 7 days in women who visit obstetric emergency departments for suspected preterm labor. The study is conducted in three phases including device development, technical validation, and clinical performance evaluation. The study involves collecting vaginal secretions from all participating women during their emergency consultation. In the first phase, clinical and ultrasound data along with placenta and membrane samples from a subset of patients are gathered to develop and refine the predictive algorithm integrated into the device. In later phases, the device's reliability and clinical performance are assessed, including administering the Edinburgh Postnatal Depression Scale (EPDS) questionnaire to participants in the clinical performance phase. Participants will be involved in sample collections, clinical assessments, and questionnaire completions at the time of emergency consultations and after delivery. Researchers will monitor delivery occurrence within 7 days as the primary outcome, along with secondary outcomes such as delivery timing at 14 days and various gestational age thresholds, neonatal mortality, severe neonatal morbidity, and EPDS scores. Follow-up assessments will continue up to 5.5 months to evaluate these outcomes and the device’s predictive value.

Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)