Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation
NCT ID: NCT05197387
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
322 participants
OBSERVATIONAL
2022-06-21
2025-06-22
Brief Summary
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If so, it would suggest the potential benefit of immunomodulatory therapeutics.
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Detailed Description
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A blood test will be performed at delivery for each woman and each newborn, in order to measure several biological parameters involved in inflammation processes, allograft rejection and angiogenesis. Placenta will also be analysed. In particular, we will look for chronic inflammation in placenta.
Biological parameters and placental parameters will be compared between the two groups: cases with ICP and controls.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
Women with intrahepatic cholestasis of pregnancy
No interventions assigned to this group
Controls
Women without intrahepatic cholestasis of pregnancy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP
Exclusion Criteria
* Women under legal protection
* Gemellar pregnancies
* Delivery before 22 Weeks of gestation
* Medical termination of pregnancy
* Acute chorioamniotitis, in particular those due to the following pathogens: toxoplasmosis, rubella, CMV, herpes virus
* Premature rupture of membranes \<37SA
* Women infected by covid-19 in the month before delivery
18 Years
60 Years
FEMALE
Yes
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHU Angers
Angers, , France
Polyclinique KERAUDREN
Brest, , France
CHU de Brest
Brest, , France
CHU de Caen
Caen, , France
CH de Chambery
Chambéry, , France
CH Bretagne Sud
Lorient, , France
CHU Nantes
Nantes, , France
CH de Quimper
Quimper, , France
CHU de Rennes
Rennes, , France
CH St Brieuc
Saint-Brieuc, , France
CHU de Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Pr
Role: backup
Karine MORCEL, [email protected]
Role: backup
References
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Du Q, Pan Y, Zhang Y, Zhang H, Zheng Y, Lu L, Wang J, Duan T, Chen J. Placental gene-expression profiles of intrahepatic cholestasis of pregnancy reveal involvement of multiple molecular pathways in blood vessel formation and inflammation. BMC Med Genomics. 2014 Jul 7;7:42. doi: 10.1186/1755-8794-7-42.
Patel S, Pinheiro M, Felix JC, Opper N, Ouzounian JG, Lee RH. A case-control review of placentas from patients with intrahepatic cholestasis of pregnancy. Fetal Pediatr Pathol. 2014 Aug;33(4):210-5. doi: 10.3109/15513815.2014.899413. Epub 2014 Apr 23.
Larson SP, Kovilam O, Agrawal DK. Immunological basis in the pathogenesis of intrahepatic cholestasis of pregnancy. Expert Rev Clin Immunol. 2016;12(1):39-48. doi: 10.1586/1744666X.2016.1101344. Epub 2015 Oct 15.
Other Identifiers
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INTREPIDE (29BRC21.0188)
Identifier Type: -
Identifier Source: org_study_id
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