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NCT06679972: CHOLE-RESP
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
trial in Intrahepatic Cholestasis of Pregnancy in 120 participants. Enrolling by invitation.
10 December 2027
Quick facts
| Lead sponsor | Carol Davila University of Medicine and Pharmacy |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 28 October 2024 |
| Primary completion | 10 December 2027 |
| Estimated completion | 1 March 2028 |
| Sites | 1 location across Romania |
Conditions studied
- Intrahepatic Cholestasis of Pregnancy — all drugs for Intrahepatic Cholestasis of Pregnancy →
- Respiratory Distress Syndrome, Newborn — all drugs for Respiratory Distress Syndrome, Newborn →
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):
-
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:
- PubMed search for NCT06679972
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Intrahepatic Cholestasis of Pregnancy
Currently open trials in the same condition.
- NCT07428226 — Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy · recruiting
Other Carol Davila University of Medicine and Pharmacy trials
Trials by the same sponsor.
- NCT07442552 — Perioperative Sepsis. An Epigenetic Perspective · recruiting
- NCT06683326 — Smart-gloves Hand Motion Tracking for Live Endoscopic Submucosal Dissection Training · NA · not yet recruiting
- NCT06224023 — Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure · recruiting
- NCT06218537 — The Role of oAncreatic Enzyme ReplAcement Therapy (PERT) on Mucosal Visibility Before Upper GI Endoscopy · NA · completed
- NCT06220175 — Pharynx Analgesia Before Upper Gastrointestinal Endoscopy · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06679972 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Carol Davila University of Medicine and Pharmacy
- Last refreshed: 18 February 2026
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