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NCT Number: NCT05197387

Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation

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.

Recruiting

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Key information

Conditions

Cholestasis of Pregnancy Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases Inflammation Intrahepatic Cholestasis of Pregnancy Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of placental chronic inflammation

    Time frame: At delivery

Secondary outcomes

  1. Levels of several biological parameters involved in inflammation processes

    Time frame: At delivery

  2. Levels of several biological parameters involved in allograft rejection

    Time frame: At delivery

  3. Levels of several biological parameters involved in angiogenesis

    Time frame: At delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Claire de Moreuil

CONTACT

[email protected]

02 98 14 53 03

Philippe Merviel

CONTACT

[email protected]

02-98-22-39-70

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Inflammation in Intrahepatic Cholestasis of Pregnancy

Acronym: INTREPIDE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2022
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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