Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-28

Study Completion Date

2028-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intrahepatic Cholestasis of Pregnancy Respiratory Distress Syndrome, Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cholestasis Group

This group will include all neonates born to mothers with intrahepatic cholestasis of pregnancy.

No interventions assigned to this group

Control Group

This group will include controls, defined as neonates born to mothers with no liver diseases.

No interventions assigned to this group

Eligibility Criteria

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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"

* 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

* no informed consent
* serum bile acids under 10 micromol/l in the last 7 days before birth
* newborns transferred from other neonatal units

CONTROL

* 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

Minimum Eligible Age

1 Hour

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes