Last reviewed · How we verify

NCT06679972: CHOLE-RESP

Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes

ENROLLING BY INVITATION Last updated 18 February 2026
What this trial tests

trial in Intrahepatic Cholestasis of Pregnancy in 120 participants. Enrolling by invitation.

Timeline
28 October 2024
Primary endpoint
10 December 2027
1 March 2028

Quick facts

Lead sponsorCarol Davila University of Medicine and Pharmacy
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment120
Start date28 October 2024
Primary completion10 December 2027
Estimated completion1 March 2028
Sites1 location across Romania

Conditions studied

Sponsor

Carol Davila University of Medicine and Pharmacy

Who can join

Adults 1 Hour to 28 Days, any sex, with Intrahepatic Cholestasis of Pregnancy or Respiratory Distress Syndrome, Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Impact of intrahepatic cholestasis of pregnancy on neonatal respiratory outcomes (CHOLE-RESP): protocol for a prospective cohort study.
    Niculae LE, Niculae AS, Tocariu R, Petca A. · · 2026 · PMID 41704598 · DOI 10.3389/fped.2026.1640579

Verify or expand the search:

Other recruiting trials for Intrahepatic Cholestasis of Pregnancy

Currently open trials in the same condition.

Other Carol Davila University of Medicine and Pharmacy trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06679972.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing