RecruitingNot Applicable

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

United States320 participantsStarted 2026-05-15

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is looking at whether amnioinfusion during labor can reduce serious breathing problems in newborns exposed to thick meconium, is amnioinfusion something that would even be considered in my situation, and what would need to be true about my labor for it to be an option?
2The trial is measuring a 'composite neonatal respiratory morbidity' outcome — can you explain what specific outcomes are bundled into that, like whether it includes things such as CPAP, surfactant use, or NICU admission, and how those risks compare to what we'd expect without any intervention?
3This study is listed as Phase NA, which often applies to procedural or device studies rather than drug trials — does that change how we should think about what's already known about the safety of amnioinfusion for both me and the baby compared to a more standard drug trial?
4The trial also tracks maternal morbidity, neonatal acidosis, and brain injury as part of what it's studying — are there any known risks to me or the baby from the amnioinfusion procedure itself that I should weigh before considering participation?
5Since this trial mentions longitudinal pediatric outcomes, meaning they may follow the baby over time after birth, what would that follow-up actually look like for our family in terms of visits, monitoring, or data collection, and how long might we be involved?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with composite neonatal respiratory morbidity

Timeframe: 72 hours after delivery

Trial details

NCT IDNCT07274527

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-15

View on ClinicalTrials.gov More Neonatal Respiratory Distress Related Conditions trials