The PEARL Trial: Randomized Study of Warm Lactated Ringer's Amnioinfusion to Protect Newborns From Respiratory and Developmental Problems After Thick Meconium Exposure

What this Trial Is About

Thick meconium in the amniotic fluid occurs in about one out of seven pregnancies and can increase the chance of breathing problems for newborns, such as needing oxygen or breathing support, NICU admission, or severe issues like meconium aspiration syndrome or persistent pulmonary hypertension. Previous studies on amnioinfusion—a procedure that places sterile fluid into the uterus during labor—had limitations like varied meconium types and inconsistent protocols. This trial aims to determine if a modern, standardized warm lactated Ringer's (LR) amnioinfusion can reduce newborn respiratory problems when thick meconium is present. Participants who are at least 36 weeks pregnant with confirmed thick meconium-stained amniotic fluid will be randomly assigned to either receive a warm LR amnioinfusion through an intrauterine pressure catheter or standard care without amnioinfusion. The intervention involves a 500 mL bolus of warmed LR infused over 30 minutes, followed by a maintenance infusion until the fluid clears or delivery occurs. Ultrasound checks and infusion details are recorded to ensure the procedure follows a strict protocol. During the study, researchers will collect umbilical cord blood at birth to measure inflammation and brain injury markers. They will monitor newborn respiratory health for 72 hours, including oxygen needs, breathing support, NICU admission, and other complications. Families will be contacted when the child is 12 months old to complete a developmental questionnaire. The trial also tracks longer-term respiratory and healthcare outcomes, aiming to provide strong evidence for care during labor when thick meconium is present.

Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure