Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes (CHOLE-RESP)

Carol Davila University of Medicine and Pharmacy

Status: Invitation-only

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

Study type: Observational

Funder types: Other

Identifiers

NCT06679972

34/15.10.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

120 participants in 2 patient groups

Cholestasis Group

Description:

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

Control Group

Description:

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