Clinical trial NCT05197387: Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation
Official title: Inflammation in Intrahepatic Cholestasis of Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholestasis of Pregnancy
Keywords: placenta
cholestasis
pregnancy
inflammation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 322
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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

Primary outcomes:
measure: Prevalence of placental chronic inflammation
timeFrame: At delivery
Secondary outcomes:
measure: Levels of several biological parameters involved in inflammation processes
timeFrame: At delivery
measure: Levels of several biological parameters involved in allograft rejection
timeFrame: At delivery
measure: Levels of several biological parameters involved in angiogenesis
timeFrame: At delivery
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: Polyclinique KERAUDREN
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de Caen
city: Chambéry
country: France
facility: CH de Chambery
city: Lorient
country: France
facility: CH Bretagne Sud
city: Nantes
country: France
facility: CHU Nantes
city: Quimper
country: France
facility: CH de Quimper
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Brieuc
country: France
facility: CH St Brieuc
city: Tours
country: France
facility: CHU de Tours
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.