Amnioinfusion to Protect Newborns After Meconium in Amniotic Fluid
Official title: The PEARL Trial: A Randomized Trial of Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Run by Medical College of Wisconsin · NCT07274527 · Data updated 2026-11-12
This trial tests whether a structured lactated Ringer's amnioinfusion during labor can reduce breathing problems and related complications in babies whose amniotic fluid contains meconium.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | May 15, 2026 |
| Main results expected | April 15, 2029 |
| Study ends | April 15, 2030 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07274527 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant people aged 18 or older with singleton gestation at ≥36 weeks who have cephalic presentation and meconium-stained amniotic fluid.
✕Probably not a fit
Candidates without meconium or with contraindications to internal monitoring may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The PEARL Trial is a randomized study enrolling moms with a singleton pregnancy at ≥36 weeks who have meconium in the amniotic fluid. Participants are assigned to receive a 500 mL LR amnioinfusion infused via an intrauterine pressure catheter or to standard obstetric care without amnioinfusion. The approach includes a defined protocol, ultrasound monitoring, and a fidelity checklist to ensure consistent delivery, with outcomes focusing on neonatal respiratory status and longer-term development. The study uses objective meconium quantification and tracks safety and adherence to the infusion protocol. Run at Froedtert Hospital and the Medical College of Wisconsin Birth Center, it is led by the Medical College of Wisconsin with collaborators from The Gerber Foundation.
Why it matters
Potential benefit: If successful, the trial could clarify whether modern, standardized amnioinfusion reduces neonatal respiratory morbidity and improves longer-term outcomes for infants exposed to meconium.
How similar studies have gone: Past amnioinfusion studies were mixed due to variability; this trial uses a standardized, modern approach to address prior limitations.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 * Meconium 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 it's running
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Froedtert Hospital and Medical College of Wisconsin Birth Center
Milwaukee, Wisconsin, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.