Amnioinfusion during labor to protect neonatal brain in chorioamnionitis
Official title: The AMNIO-BRAIN Trial: A Randomized Trial of Amnioinfusion for Chorioamnionitis Targeting Neonatal Brain Injury Biomarkers
Run by Medical College of Wisconsin · NCT07610642 · Data updated 2026-11-12
This trial tests whether giving fluid into the uterus during labor for pregnancies affected by chorioamnionitis can help protect the baby’s brain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | October 15, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07610642 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals aged 18 or older, with singleton gestation, at 36 weeks or more, in labor, and clinical chorioamnionitis or intra-amniotic infection per ACOG criteria.
✕Probably not a fit
Patients without chorioamnionitis, multifetal gestations, major fetal anomalies, or contraindications to vaginal delivery 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 AMNIO-BRAIN Trial is a randomized study enrolling 80 maternal–infant pairs at ≥36 weeks' gestation to test intrauterine amnioinfusion during labor in the setting of clinical chorioamnionitis. The study aims to see if this procedure can reduce molecular biomarkers of neonatal brain injury at birth and potentially improve outcomes. Interventions include intrauterine pressure catheter use and standard obstetric care, with eligibility limited to adults with singleton pregnancies and laboring under documented infection per ACOG criteria. Prior pilot data suggested inflammatory and metabolic markers may be favorably altered by amnioinfusion, providing a rationale for intrapartum neuroprotection. The trial is conducted at Froedtert Hospital and the Medical College of Wisconsin Birth Center.
Why it matters
Potential benefit: If successful, the approach could lessen early brain injury in newborns affected by intrauterine infection and reduce related morbidity.
How similar studies have gone: Pilot randomized data suggested reductions in intrauterine temperature and a downstream biomarker (umbilical artery lactate) with amnioinfusion, supporting continued evaluation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maternal age ≥18 years * Singleton gestation * Gestational age ≥36 weeks * Labor at time of enrollment * Clinical chorioamnionitis or intra-amniotic infection defined according to ACOG criteria, including: Maternal temperature ≥38.0°C At least one associated clinical finding, including: * 1\. Maternal leukocytosis * 2\. Purulent cervical drainage * 3\. Fetal tachycardia * Cervical dilation sufficient for intrauterine pressure catheter placement * Ability to provide informed consent Exclusion Criteria: * Multifetal gestation * Known major fetal anomaly * Contraindication to vaginal delivery * Placenta previa * Category III fetal heart tracing requiring immediate delivery * Non-English-speaking
Where it's running
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Froedtert Hospital and Medical College of Wisconsin Birth Center
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Study coordinator: Brock E Polnaszek, MD,MPH
- Email: bpolnaszek@mcw.edu
- Phone: (414)-805-6600
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Amnioinfusion to Protect Newborns After Meconium in Amniotic Fluid
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.
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Clemastine for Neonatal White Matter Injury
This small, early-stage study tests whether the drug clemastine is safe to give by mouth to premature babies with white matter injury and how the body handles the drug.
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Amniotic fluid and the extremely preterm baby's gut
We will see if amniotic fluid from extremely preterm births (24+0 to 27+6 weeks) shows changes that relate to gut problems such as necrotizing enterocolitis or sepsis in very preterm infants.
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.