NCT07274527 · Medical College of Wisconsin
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure
(PEARL)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Intrauterine pressure catheter
Standardized warm amnioinfusion consisting of a 500 mL bolus of warmed (37°C) lactated ringer's infused over 30 minutes through an intrauterine pressure catheter (IUPC), followed by a continuous maintenance infusion of 125 mL/hour until the amniotic fluid clears or delivery.
OTHER
Standard obstetric care at discretion of delivery provider
Route obstetric care at discretion of delivery provider
Primary outcome measures
Number of participants with composite neonatal respiratory morbidity
Time frame: 72 hours after delivery
Composite neonatal respiratory morbidity including continuous positive airway pressure (CPAP) \>6 hours, oxygen \>24 hours, intubation, persistent pulmonary hypertension (PPHN), surfactant use, inhaled nitric oxide, extracorporeal membrane oxygenation (ECMO), neonatal intensive care unit (NICU) admission, or perinatal death.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Milwaukee, Wisconsin
Collaborators
The Gerber Foundation
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Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations