Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes (NCT06679972) | Clinical Trial Compass
By InvitationNot Applicable
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Romania120 participantsStarted 2024-10-28
Plain-language 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.
Who can participate
Age range
1 Hour – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
ICP-EXPOSED GROUP
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" or transferred to our unit in the first 24 hours of life
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 after 24 hours of life
UNEXPOSED GROUP
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 ICP-exposed group
Exclusion Criteria:
\- ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of respiratory distress syndrome
Timeframe: First 72 hours of life
2
The need for exogenous surfactant administration
Timeframe: First 72 hours of life
3
Biomarkers related to pulmonary injury and surfactant deficiency
Timeframe: In the first 24 hours, at 48-72 hours and at 7 days of life
Trial details
NCT IDNCT06679972
SponsorCarol Davila University of Medicine and Pharmacy