Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes

• Conditions: Intrahepatic Cholestasis of Pregnancy; Respiratory Distress Syndrome, Newborn

• Registration Number: NCT06679972
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

Brief Summary

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.

Detailed Description

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 the neonatal population to establish a definitive conclusion regarding neonatal pulmonary impairment secondary to maternal bile acid accumulation.

Study Timeline

• Study Start: 2024-10-28
• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Primary Completion: 2027-12-10
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarkers of epithelial injury	In the first 24 hours, at 2-3 days and at 7 days of life	This trial wishes to evaluate if neonates born to mothers with intrahepatic cholestasis of pregnancy are prone to develop a more extensive epithelial injury compared to those of similar gestational age/birthweight/sex born to mothers with no liver disease.

Trial Locations

Locations (1)

Clinical Hospital of Obstetrics and Gynecology "Prof. Dr. Panait Sârbu"; 🇷🇴 Bucharest, Romania