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NCT07274527 · ClinicalTrials.gov registry record · NA
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure
A NA study, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- NA
- Development phase
- 320
- Enrollment target
NCT07274527 is a NA study that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 320 participants.
The verdict
NCT07274527, a NA study, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- NA
- Development phase
- 320 participants
- Enrollment target
Study 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
Interventions
- DEVICE Intrauterine pressure catheter
- OTHER Standard obstetric care at discretion of delivery provider
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2026-05-15 |
| Est. Completion | 2030-04-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07274527
The ClinicalTrials.gov registry entry for NCT07274527 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intrauterine pressure catheter is the first listed.
NCT07274527 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07274527 about?
NCT07274527 is a clinical study titled "Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure". 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 ca...
What is the current status of trial NCT07274527?
This trial is currently recruiting. It is a NA study. The enrollment target is 320 participants. The study started on 2026-05-15. Estimated completion is 2030-04-15.
What interventions are being tested in trial NCT07274527?
The interventions under investigation include: Intrauterine pressure catheter (DEVICE), Standard obstetric care at discretion of delivery provider (OTHER).
Who is sponsoring clinical trial NCT07274527?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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