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.
Study Type
OBSERVATIONAL
Enrollment
120
Clinical Hospital of Obstetrics and Gynecology "Prof. Dr. Panait Sârbu"
Bucharest, Bucharest, Romania
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
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Time frame: From day 1 of life until 28 days of life