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Search / Trial NCT06679972

Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes

Launched by CAROL DAVILA UNIVERSITY OF MEDICINE AND PHARMACY · Nov 7, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Bile Acid Pneumonia Cholestasis Of Pregnancy Intrahepatic Cholestasis Rds Respiratory Distress Syndrome

ClinConnect Summary

Intrahepatic cholestasis of pregnancy is a hepatic complication that predominantly arises during the second or third trimester. It is characterized by serum bile acid levels above 10 micromol/L and persistent pruritus, which resolves after delivery. To date, it has been observed that respiratory distress syndrome occurs more frequently in neonates born to mothers with cholestasis of pregnancy, and a potential new entity, 'acute bile acid-induced pneumonia,' has been proposed, though statistical confirmation is lacking. Therefore, the investigators deem it imperative to conduct a study in th...

Gender

ALL

Eligibility criteria

  • CASE
  • Inclusion Criteria:
  • mother with recent diagnosis of intrahepatic cholestasis of pregnancy (serum bile acids over 10 micromol/l in the last 7 days before birth), with informed consent given a few hours before giving birth
  • ursodeoxycholic acid, independent of dosage or initiation of treatment
  • neonates born in Clinical Hospital of Obstetrics and Gynecology "Prof.Dr. Panait Sirbu"
  • Exclusion Criteria:
  • no informed consent
  • serum bile acids under 10 micromol/l in the last 7 days before birth
  • newborns transferred from other neonatal units
  • CONTROL
  • Inclusion Criteria:
  • mother with no history of hepatic disease during or before the current pregnancy, with informed consent given a few hours before giving birth
  • neonates born in Clinical Hospital of Obstetrics and Gynecology "Prof.Dr. Panait Sirbu", of similar gestational age/weight/sex at birth to corresponding neonates in the cholestasis group
  • Exclusion Criteria:
  • ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases)
  • newborns transferred from other neonatal units, with different gestational age/weight/sex than cases

About Carol Davila University Of Medicine And Pharmacy

Carol Davila University of Medicine and Pharmacy is a prestigious academic institution located in Bucharest, Romania, renowned for its commitment to advancing medical education, research, and healthcare innovation. As a clinical trial sponsor, the university leverages its extensive research capabilities and experienced faculty to conduct rigorous clinical studies that aim to enhance medical knowledge and improve patient outcomes. With a focus on ethical standards and patient safety, the university collaborates with various stakeholders, including healthcare professionals and industry partners, to foster groundbreaking research that addresses pressing medical challenges.

Locations

Bucharest, , Romania

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported