Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Starting soon · Not applicable
Conditions studied: Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion, Neonatal Brain Injury
In brief
The AMNIO-BRAIN Trial is a research study looking at whether a simple treatment during labor can help protect a baby's brain. Some newborns develop a condition called hypoxic-ischemic encephalopathy (HIE), which happens when the brain does not get enough oxygen or blood flow. This can lead to serious health problems, including developmental delays and lifelong disabilities. While there is a cooling treatment after birth that can help, it starts only after delivery and may come too late to prevent the earliest stages of injury. Research suggests that some brain injury may actually begin during labor, especially when there is an infection in the uterus called chorioamnionitis. This infection can cause inflammation and fever in the mother, which may increase stress on the baby and affect the baby's brain. This study is testing whether a commonly used labor procedure called amnioinfusion can help. Amnioinfusion involves placing fluid similar to your biologic amniotic fluid into the uterus during labor. It is already used safely in many deliveries for other reasons. In prior research, this treatment slightly lowered the temperature inside the uterus and improved signs that the baby was no longer under stress. In this study, 80 pregnant subjects with chorioamnionitis will be randomly assigned to receive amnioinfusion during labor or receive standard care without amnioinfusion. All patients will continue to receive normal treatment for infection. After delivery, researchers will collect a small sample of blood from the umbilical cord. This blood will be tested for markers that can show whether the baby may have experienced stress or injury to the brain.
Key facts
- Study ID
- NCT07610642
- Run by
- Medical College of Wisconsin
- People needed
- 80
- Starts
- 2026-07-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Froedtert Hospital and Medical College of Wisconsin Birth Center — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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