Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure
Recruiting now · Not applicable
Conditions studied: Neonatal Respiratory Distress Related Conditions, Meconium, Perinatal Morbidity, Neonatal Acidosis, Cord Blood, Neonatal Brain Injury, Maternal Morbidity, Mechanical Ventilation, CPAP, Surfactant, Perinatal Death, Amnioinfusion, NICU Admission
In brief
Thick meconium in the amniotic fluid occurs in about one out of seven pregnancies and increases the chance that a newborn may have breathing problems after birth. These problems can include the need for oxygen, breathing support, admission to the neonatal intensive care unit (NICU), or, in severe cases, meconium aspiration syndrome or persistent pulmonary hypertension. Although amnioinfusion or placing sterile fluid into the uterus during labor was previously studied as a way to reduce these complications, earlier research had major limitations. Past studies included all types of meconium, used different fluid types and temperatures, had inconsistent protocols, and did not measure biomarkers of inflammation or look at long-term outcomes. As a result, it is still unclear whether a modern, standardized approach to amnioinfusion can meaningfully improve newborn health when the meconium is truly thick. The PEARL Trial is a randomized clinical trial designed to answer this question. The study will enroll pregnant individuals at or beyond 36 weeks of gestation who develop thick meconium-stained amniotic fluid, confirmed using a simple, objective measurement ("meconium-crit"). Participants will be randomly assigned to receive either: Warm lactated Ringer's (LR) amnioinfusion through an intrauterine pressure catheter (IUPC), following a standardized protocol, or standard care without amnioinfusion. The main goal is to determine whether warm LR amnioinfusion reduces short-term breathing problems in newborns. The study also collects umbilical cord blood at birth to evaluate markers of inflammation and potential brain injury, which may help explain why some infants develop complications. Families will also be contacted when their child is 12 months old to complete a developmental questionnaire that is widely used in pediatric practice. By using a clear definition of thick meconium, a warm LR infusion protocol, fidelity checklists, and long-term follow-up, this trial aims to provide high-quality evidence to guide care in labor and delivery units nationwide.
Key facts
- Study ID
- NCT07274527
- Run by
- Medical College of Wisconsin
- People needed
- 320
- Starts
- 2026-05-15
- Expected to finish
- 2030-04-15
- Last updated by the study team
- 2026-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Maternal age greater than or equal to 18 years old
- Singleton pregnancy
- Gestational age of greater than or equal to 36 weeks 0 days gestation
- Cephalic presentation
- Cercial dilation between 2-10 centimeters
- Meconium
You may not qualify if…
- Major fetal anomaly
- Multiple gestation
- Eunice Kennedy Shrive National Institute of Child Health and Human Developmet (NICHD) Category III fetal heart tracing
- Contraindication to internal monitors
- Prelabor premature ruptuore of membranes before 36 weeks 0 days gestation, - Inability to consent
Where it is running
- Froedtert Hospital and Medical College of Wisconsin Birth Center — Milwaukee, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.