An observational study in Cholestasis of Pregnancy, sponsored by University Hospital, Brest. Recruiting at 11 sites in France. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by University Hospital, Brest · Observational
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.
26 studies on the registry are indexed under Intrahepatic Cholestasis of Pregnancy; 10 are open to participants now.
This study's planned enrollment of 322 is above the median of 118 across 18 observational studies indexed under Intrahepatic Cholestasis of Pregnancy.
Browse Intrahepatic Cholestasis of Pregnancy studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP
Exclusion Criteria:
Women with intrahepatic cholestasis of pregnancy
Women without intrahepatic cholestasis of pregnancy
Prevalence of placental chronic inflammation
Time frame: At delivery
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
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
Time frame: Data will be available beginning two years and ending five years following the publication
Access criteria: 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.
Started Jun 2022 (actual). Primary completion is estimated for Jun 2025, 36 months after the start.
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Intrahepatic Cholestasis of Pregnancy →