Cholestasis of PregnancyINTREPIDENCT05197387
Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation
An observational study of Cholestasis of Pregnancy, run by University Hospital, Brest at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cholestasis of Pregnancy
- How many people
- 322 participants
- Where
- 11 sitesFrance
- Study dates
- 21 Jun 2022to 22 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Adult pregnant woman with singleton
- For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
CHU Angers
Angers
Véronique BEAUDOUX, veronique.beaudoux@chu-angers.fr
- Recruiting
Polyclinique KERAUDREN
Brest, 29200
Maryline Maryline Pluchon, maryline.pluchon@gmail.com
- Recruiting
CHU de Brest
Brest, 29609
Claire de Moreuil, claire.demoreuil@chu-brest.fr
Pr
- Recruiting
CHU de Caen
Caen, 14000
Michel Dreyfus, dreyfus-m@chu-caen.fr
- Recruiting
CH de Chambery
Chambéry, 75300
Emmanuel Decroisette, emmanuelle.decroisette@ch-metropole-savoie.fr
- Recruiting
CH Bretagne Sud
Lorient, 56100
Stéphanie Pittion-Quiniou, s.quinioupittion@ghbs.bsh
- Recruiting
CHU Nantes
Nantes
Norbert WINER, norbert.winer@chu-nantes.fr
Morgane VINCKE, morgane.vincke@chu-nantes.fr
- Recruiting
CH de Quimper
Quimper, 29000
Camille SAUVEE, c.sauvee@ch-cornouaille.fr
- Recruiting
CHU de Rennes
Rennes, 35000
Linda Lassel, linda.lassel@chu-rennes.fr
- Recruiting
CH St Brieuc
Saint-Brieuc
Claire COMBESCURE, claire.combescure@armorsante.bzh
- Recruiting
CHU de Tours
Tours, 37044
Franck Perrotin, franck.perrotin@med-univ-tours.fr
About this study
Official title: Inflammation in Intrahepatic Cholestasis of Pregnancy
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.
Read the 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.
- Conditions
- Cholestasis of Pregnancy
- Keywords
- placenta, cholestasis, pregnancy, inflammation
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy, Cholestasis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Women with intrahepatic cholestasis of pregnancy | |
| Controls | Women without intrahepatic cholestasis of pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of placental chronic inflammation
Measured: At delivery
Secondary outcomes (3)
Levels of several biological parameters involved in inflammation processes
Measured: At delivery
Levels of several biological parameters involved in allograft rejection
Measured: At delivery
Levels of several biological parameters involved in angiogenesis
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start21 Jun 2022
- Primary completion21 Jun 2025 (estimated)
- Study completion22 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cholestasis of PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197387
- Sponsor's protocol ID
- INTREPIDE (29BRC21.0188)
- Acronym
- INTREPIDE
- Status last verified
- Oct 2024
- First submitted
- 5 Jan 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
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.
PubMed 25001852Patel 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.
PubMed 24758367Larson 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.
PubMed 26469633
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation in Intrahepatic Cholestasis of Pregnancy
- ClinicalTrials.gov ID
- NCT05197387
- Acronym / sponsor ID
- INTREPIDE / INTREPIDE (29BRC21.0188)
- Conditions
- Cholestasis of Pregnancy
- Keywords
- placenta, cholestasis, pregnancy, inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 21 Jun 2025 (estimated)
- Study completion
- 22 Jun 2025 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Women with intrahepatic cholestasis of pregnancy |
| Controls | – | –Women without intrahepatic cholestasis of pregnancy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Adult pregnant woman with singleton
- For cases: diagnosis of intrahepatic cholestasis of pregnancy For controls: no diagnosis of ICP
Key exclusion criteria (8 listed)
- Women under 18 years old
- Women under legal protection
- Gemellar pregnancies
- Delivery before 22 Weeks of gestation
- Medical termination of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of placental chronic inflammation
Time frame: At delivery
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 25001852Du 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.
- Background: PubMed 24758367Patel 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.
- Background: PubMed 26469633Larson 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholestasis of Pregnancy, run by University Hospital, Brest at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire de Moreuil (02 98 14 53 03, claire.demoreuil@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of placental chronic inflammation (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197387, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.