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Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes

Study acronym: CHOLE-RESP
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Notable Primary endpoints: 1 to 3
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints expanded, about 9 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth. Babies born to mothers with this condition may have a higher risk of breathing issues. Researchers suspect bile acids might lead to a specific type of lung problem in newborns, but more studies are needed to confirm this.
Trial Details
NCT Number NCT06679972
Lead Sponsor Carol Davila University of Medicine and Pharmacy
Conditions
(from sponsor)
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Related terms Cholestasis, Intrahepatic, Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Respiratory Distress Syndrome, Newborn
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov