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Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers

RecruitingNAAges 18 Years - anyAllMedical College of Wisconsin
NCT07610642 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Intrauterine Pressure Catheter
  • Standard obstetric care at discretion of delivery provider
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Where

1 site
Froedtert Hospital and Medical College of Wisconsin Birth Center
Milwaukee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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