Vaginal Progesterone to Prevent Spontaneous Preterm Birth in Women With a Sonographic Short Cervix: The Story of the PREGNANT Trial
Roberto Romero, Arun Meyyazhagan, Sonia S. Hassan, George W. Creasy, Agustín Conde-Agudelo
Abstract
The PREGNANT trial was a randomized, placebo-controlled, multicenter trial designed to determine the efficacy and safety of vaginal progesterone (VP) to reduce the risk of birth < 33 weeks and of neonatal complications in women with a sonographic short cervix (10 to 20 mm) in the mid-trimester (19 to 23 6/7 wk). Patients allocated to receive VP had a 45% lower rate of preterm birth (8.9% vs 16.1%; relative risk = 0.55; 95% CI: 0.33-0.92). Neonates born to mothers allocated to VP had a 60% reduction in the rate of respiratory distress syndrome. This article reviews the background, design, execution, interpretation, and impact of the PREGNANT Trial.
Topics & Concepts
MedicineObstetricsCervixRandomized controlled trialRespiratory distressGynecologyPlaceboPregnancyRelative riskSurgeryConfidence intervalCancerInternal medicinePathologyAlternative medicineBiologyGeneticsPreterm Birth and ChorioamnionitisPregnancy-related medical researchMaternal and Perinatal Health Interventions