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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Women with intrahepatic cholestasis of pregnancy | ||
| Controls | Women without intrahepatic cholestasis of pregnancy |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of placental chronic inflammation | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of several biological parameters involved in inflammation processes | At delivery | |
| Levels of several biological parameters involved in allograft rejection | At delivery | |
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Inclusion Criteria:
For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP
Exclusion Criteria:
Pregnant woman
Pregnant women with or without intrahepatic cholestasis of pregnancy included at delivery.
Each control will be matched with each case according to gestation age at delivery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire de Moreuil | Contact | 02 98 14 53 03 | claire.demoreuil@chu-brest.fr | |
| Philippe Merviel | Contact | 02-98-22-39-70 | philippe.merviel@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Not yet recruiting | Angers | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25001852 | Background | 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. | |
| 24758367 | Background |
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All collected data that underlie results in a publication
Data will be available beginning two years and ending five years following the publication
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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| ID | Term |
|---|---|
| C535932 | Intrahepatic Cholestasis of Pregnancy |
| D002779 | Cholestasis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
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Whole blood
| Levels of several biological parameters involved in angiogenesis |
| At delivery |
| Polyclinique KERAUDREN | Recruiting | Brest | 29200 | France |
|
| CHU de Brest | Recruiting | Brest | 29609 | France |
|
| CHU de Caen | Recruiting | Caen | 14000 | France |
|
| CH de Chambery | Recruiting | Chambéry | 75300 | France |
|
| CH Bretagne Sud | Recruiting | Lorient | 56100 | France |
|
| CHU Nantes | Recruiting | Nantes | France |
|
| CH de Quimper | Recruiting | Quimper | 29000 | France |
|
| CHU de Rennes | Recruiting | Rennes | 35000 | France |
|
| CH St Brieuc | Recruiting | Saint-Brieuc | France |
|
| CHU de Tours | Recruiting | Tours | 37044 | France |
|
| 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. |
| 26469633 | Background | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |