Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cholestasis of Pregnancy. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Inflammation in Intrahepatic Cholestasis of Pregnancy
Overview
This observational prospective study will help to determine if an immune process similar to allograft rejection is responsible for the occurrence of an intrahepatic cholestasis of pregnancy (ICP). If so, it would suggest the potential benefit of immunomodulatory therapeutics.
Detailed description
This observational study will include 322 pregnant women at delivery: 161 women diagnosed with an intrahepatic cholestasis of pregnancy, and 161 control women.
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.
Primary outcome measures
- Prevalence of placental chronic inflammation [Time frame: At delivery]
Secondary outcome measures (3)
- Levels of several biological parameters involved in inflammation processes [Time frame: At delivery]
- Levels of several biological parameters involved in allograft rejection [Time frame: At delivery]
- Levels of several biological parameters involved in angiogenesis [Time frame: At delivery]
Eligibility criteria
Inclusion criteria
- Adult pregnant woman with singleton
For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP
Exclusion criteria
- Women under 18 years old
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 11 centers
- CHU Angers — Angers
- Polyclinique KERAUDREN — Brest
- CHU de Brest — Brest
- CHU de Caen — Caen
- CH de Chambery — Chambéry
- CH Bretagne Sud — Lorient
- CHU Nantes — Nantes
- CH de Quimper — Quimper
- … and 3 more centers
Publications
- 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. PMID 25001852
- 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. PMID 24758367
- 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. PMID 26469633
Identifiers
NCT: NCT05197387 · INTREPIDE (29BRC21.0188)