An observational study in Intrahepatic Cholestasis of Pregnancy and Respiratory Distress Syndrome, Newborn, sponsored by Carol Davila University of Medicine and Pharmacy. Enrolling by invitation at 1 site in Romania. Open to participants aged 1 Hour to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Carol Davila University of Medicine and Pharmacy · Observational
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.
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.
26 studies on the registry are indexed under Intrahepatic Cholestasis of Pregnancy; 10 are open to participants now.
This study's planned enrollment of 120 is close to the median of 118 across 18 observational studies indexed under Intrahepatic Cholestasis of Pregnancy.
Browse Intrahepatic Cholestasis of Pregnancy studies →Carol Davila University of Medicine and Pharmacy is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will include selected neonates born at term or preterm age, in a third degree neonatal unit in Bucharest, Romania (Clinical Hospital of Obstetrics and Gynecology "Prof.Dr. Panait Sirbu"). For the ICP-exposed group, the study population is represented by neonates born to mothers with intrahepatic cholestasis diagnosed during pregnancy. The unexposed group will include neonates of similar gestational age/weight/sex at birth born to mothers with no hepatic diseases.
ICP-EXPOSED GROUP
Inclusion Criteria:
Exclusion Criteria:
UNEXPOSED GROUP
Inclusion Criteria:
Exclusion Criteria:
- ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will include all neonates born to mothers with intrahepatic cholestasis of pregnancy.
This group will include neonates born to mothers without a known history of hepatic disease prior to or during the index pregnancy. Controls will be matched according to gestational age at birth, birthweight and sex.
Incidence of respiratory distress syndrome
RDS is defined as a clinical diagnosis made within the first 72 hours of life, based on signs of respiratory compromise (tachypnea, grunting, nasal flaring, chest retractions), supportive radiographic findings and a need for supplemental oxygen or respiratory support.
Time frame: First 72 hours of life
The need for exogenous surfactant administration
Surfactant administration refers to any administration of exogenous surfactant therapy within the first 72 hours of life, regardless of dosing or mode of delivery.
Time frame: First 72 hours of life
Biomarkers related to pulmonary injury and surfactant deficiency
This trial seeks to determine whether neonates exposed to intrahepatic cholestasis of pregnancy exhibit distinct serum biomarker profiles consistent with lung injury and surfactant impairment, compared to those of similar gestational age/birthweight/sex born to mothers with no liver disease.
Time frame: In the first 24 hours, at 48-72 hours and at 7 days of life
Respiratory morbidity
This includes the need for mechanical ventilation and non-invasive respiratory support, as well as the occurrence of serious respiratory complications including pneumothorax, pulmonary hemorrhage and persistent pulmonary hypertension.
Time frame: First 7 days of life
NICU admission
Time frame: First 48-72 hours of life
Length of hospitalization
Time frame: From day 1 of life until discharge
Neonatal mortality
Time frame: From day 1 of life until 28 days of life
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Dec 2027, 37 months after the start.
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Intrahepatic Cholestasis of Pregnancy →
Carol Davila University of Medicine and Pharmacy