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

NCT07274527 | Not Yet Recruiting FDA Device

• 1 other identifier: PRO00054878
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Amnioinfusion; Meconium; Neonatal morbidity; Developmental Screening; Maternal Morbidity; Neonatal respiratory morbidity; Umbilical cord gas and biomarkers; Healthcare Utilization

Outcome Measures

Primary Outcomes (1)

• Number of participants with composite neonatal respiratory morbidity

  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.

  72 hours after delivery

Secondary Outcomes (4)

• Concentration of umbilical cord gas values

  At delivery

• Concentration of umbilical cord blood biomarkers

  At delivery and if measured in the neonate as a part of usual care

• Scores on developmental screening

  1 year after delivery

• Number of participants with composite maternal morbidity

  Through 6 weeks postpartum

Other Outcomes (6)

• Number of participants with healthcare utilization

  1 year after delivery

• Number of participants in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Electronic (NICHD) Fetal Monitoring categories

  During labor and delivery

• Number of participants experiencing pre-defined fidelity metrics

  Randomization to 48 hours after birth

Study Arms (2)

Warm Lactated Ringer Amnioinfusion

EXPERIMENTAL

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. Re-administration is permitted if thick meconium persists or the deepest amniotic fluid pocket is \<2 cm by ultrasound.

Device: Intrauterine pressure catheter

Standard of Care

PLACEBO COMPARATOR

Standard obstetric care will be at the discretion of the delivery provider.

Other: Standard obstetric care at discretion of delivery provider

Interventions

Intrauterine pressure catheter DEVICE

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.

Also known as: Amnioinfusion

Warm Lactated Ringer Amnioinfusion

Standard obstetric care at discretion of delivery provider OTHER

Route obstetric care at discretion of delivery provider

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Froedtert Hospital and Medical College of Wisconsin Birth Center

Milwaukee, Wisconsin, 53045, United States

Location

Related Publications (1)

• Davis JD, Sanchez-Ramos L, McKinney JA, Lin L, Kaunitz AM. Intrapartum amnioinfusion reduces meconium aspiration syndrome and improves neonatal outcomes in patients with meconium-stained fluid: a systematic review and meta-analysis. Am J Obstet Gynecol. 2023 May;228(5S):S1179-S1191.e19. doi: 10.1016/j.ajog.2022.07.047. Epub 2023 Mar 18.

  PMID: 37164492 BACKGROUND

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Clinical Investigator

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)