Actively Recruiting
Led by University Hospital, Brest · Updated on 2024-10-16
322
Participants Needed
11
Research Sites
N/A
Total Duration
This research aims to understand whether an immune process similar to allograft rejection causes intrahepatic cholestasis of pregnancy (ICP). The study includes pregnant women with and without ICP to explore if immunomodulatory treatments might be helpful. It is an observational study conducted by the University Hospital, Brest, focused on inflammation in ICP. The study involves 322 pregnant women at delivery, divided into two groups: 161 women diagnosed with ICP and 161 without ICP. Blood tests will be performed on both mothers and newborns to measure various biological markers related to inflammation, allograft rejection, and angiogenesis. Placental tissue will also be analyzed to check for chronic inflammation. Participants will provide blood samples and placenta at delivery for detailed analysis. Researchers will compare biological and placental markers between the ICP and non-ICP groups. The main outcome measured is the prevalence of placental chronic inflammation at delivery, alongside levels of biological factors involved in inflammation, rejection, and angiogenesis. The study will monitor these outcomes at delivery and conclude by June 2025.
CONDITIONS
Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit at delivery (in-person)
Duration - At delivery
Participants undergo blood tests and placental analysis at delivery to measure biological parameters involved in inflammation, allograft rejection, and angiogenesis, and to assess chronic inflammation in the placenta.
1 visit at delivery (in-person)
Total: 11 locations
1
CHU Angers
Angers, France
Not Yet Recruiting
2
Polyclinique KERAUDREN
Brest, France, 29200
Actively Recruiting
3
CHU de Brest
Brest, France, 29609
Actively Recruiting
4
CHU de Caen
Caen, France, 14000
Actively Recruiting
5
CH de Chambery
Chambéry, France, 75300
Actively Recruiting
6
CH Bretagne Sud
Lorient, France, 56100
Actively Recruiting
7
CHU Nantes
Nantes, France
Actively Recruiting
8
CH de Quimper
Quimper, France, 29000
Actively Recruiting
9
CHU de Rennes
Rennes, France, 35000
Actively Recruiting
10
CH St Brieuc
Saint-Brieuc, France
Actively Recruiting
11
CHU de Tours
Tours, France, 37044
Actively Recruiting
C
Claire de Moreuil
P
Philippe Merviel
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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