Pre-eclampsiaNCT05188066
Study of Pregnancy Pathologies Associated With Placental Abnormalities
An observational study of Pre-eclampsia and Pre-Term, run by University Hospital, Grenoble.
Trial summary
Pregnancy pathologies can occur from implantation until childbirth. The investigators are interested in the development mechanisms of these pathologies and aim to develop therapies to treat them. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-eclampsia, Pre-Term, Fetal Growth Retardation
- What is being tested?
- Histology
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2022to 31 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 52 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will include normal and pathological pregnant women from first to third trimester. A finaliser
Who may be able to join
- Adult women
- Admitted to the CHUGA for a birth or an abortion.
- Pregnant women consenting to the collection of their fetal placenta membranes, during premature deliveries or at term of pregnancy OR Women performing an abortion consenting to the collection of their abortion products.
- Having signed a consent
- Affiliated with social security
Who cannot join
- Placental sample or abortion product unavailable (not collected or necessary for treatment).
- Patient with known positive HIV or Hepatitis B or Hepatitis C serology or at risk according to the infectious safety criteria applied by the EFS.
- hemoglobin <7d / dL or hemoglobin <10g / dL if she suffers from a cardio-respiratory pathology).
- Patient protected by law (minor, hospitalized under duress, subject to a legal protection measure by guardianship or curatorship, deprived of liberty by judicial or administrative decision)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Pregnancy pathologies can occur from implantation until childbirth. The investigators are interested in the development mechanisms of these pathologies and aim to develop therapies to treat them.
The investigators need to collect samples, especially placental samples, following abortions and term and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for the understanding of the histological changes that occur in normal placentas collected at term of pregnancy. The latter will, in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of pre-eclampsia. This study will allow investigators to advance their understanding of the pathophysiological mechanisms of the placenta. The investigators are internationally recognized for their research on these pathologies.
Read the detailed description
Pregnancy pathologies can occur from implantation until childbirth. Clinical and scientific investigators are interested in the study of the mechanisms of development of these pathologies and aim to develop therapies to treat them.
The investigators need to collect samples, especially placental samples, following abortions, term, and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for understanding the histological changes that occur in normal placentas collected at term of pregnancy. The latter, will in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of preeclampsia. This study will allow investigators to advance the understanding of the pathophysiological mechanisms of the placenta.
The investigators are internationally recognized for its research on these thematic.
- Conditions
- Pre-eclampsia, Pre-Term, Fetal Growth Retardation
- Being tested
- Histology
- Keywords
- pre-eclampsia, fetal growth retardation, placenta histology, vascularization, trophoblast proliferation
- Medical subject headings
- Pre-Eclampsia, Premature Birth, Fetal Growth Retardation, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistologyDiagnostic test
Also called immunohistochemistry
Collect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses
| Study group | Role | What they receive |
|---|---|---|
| Normal, pathological IVG | We will use placenta and fetal memebranes collected from first trimester termination of pregnancy. This will constitute group IVG. Receives: Diagnostic Test: Histology | |
| Normal and pathological term | We will also use the same specimens collected from third trimester pregnancies . We will call this group normal and pathological..... à finaliser Receives: Diagnostic Test: Histology |
What is being measured
The primary outcome is the main question the study is designed to answer.
To better characterize pregnancy pathologies from implantation to childbirth
Comparison of the frequencies (in percentage) of the histological differences of the placenta and its appendages in patients with pathological and normal pregnancies (histological differences of normal pregnancies versus pathological pregnancies.
Measured: Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hours
Secondary outcomes (1)
Link between the frequencies of histological aberrations and worsening of the pathology
Comparison of the severity of the pathology according to the frequencies of aberrations
Measured: Assessement of the link between the frequencies of histological aberrations and worsening of the pathology will be assessed on the final cohort; This will take up to 3 hours for each aberration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start6 Jan 2022 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale Hoffmann, MD PHD, Principal investigator, Grenoble hospitalNadia Alfaidy, PhD, Study director, INSERM U1292
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188066
- Sponsor's protocol ID
- 38RC20.115
- Status last verified
- Jan 2022
- First submitted
- 18 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pregnancy Pathologies Associated With Placental Abnormalities
- ClinicalTrials.gov ID
- NCT05188066
- Acronym / sponsor ID
- 38RC20.115
- Conditions
- Pre-eclampsia, Pre-Term, Fetal Growth Retardation
- Keywords
- pre-eclampsia, fetal growth retardation, placenta histology, vascularization, trophoblast proliferation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 6 Jan 2022 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 12 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.
Pregnancy pathologies can occur from implantation until childbirth. The investigators are interested in the development mechanisms of these pathologies and aim to develop therapies to treat them.
The investigators need to collect samples, especially placental samples, following abortions and term and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for the understanding of the histological changes that occur in normal placentas collected at term of pregnancy. The latter will, in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of pre-eclampsia. This study will allow investigators to advance their understanding of the pathophysiological mechanisms of the placenta. The investigators are internationally recognized for their research on these pathologies.
Detailed description
Pregnancy pathologies can occur from implantation until childbirth. Clinical and scientific investigators are interested in the study of the mechanisms of development of these pathologies and aim to develop therapies to treat them.
The investigators need to collect samples, especially placental samples, following abortions, term, and premature deliveries. Abortions will allow investigators to have non-pathological placental material up to 13 weeks. This material will serve as a reference for understanding the histological changes that occur in normal placentas collected at term of pregnancy. The latter, will in turn, be compared with the placentas collected during premature deliveries. Also, the abortion product will be cultivated in an environment mimicking the pathology of preeclampsia. This study will allow investigators to advance the understanding of the pathophysiological mechanisms of the placenta.
The investigators are internationally recognized for its research on these thematic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal, pathological IVG | – | Diagnostic Test: HistologyWe will use placenta and fetal memebranes collected from first trimester termination of pregnancy. This will constitute group IVG. |
| Normal and pathological term | – | Diagnostic Test: HistologyWe will also use the same specimens collected from third trimester pregnancies . We will call this group normal and pathological..... à finaliser |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include normal and pathological pregnant women from first to third trimester. A finaliser
Key inclusion criteria (5 listed)
- Adult women
- Admitted to the CHUGA for a birth or an abortion.
- Pregnant women consenting to the collection of their fetal placenta membranes, during premature deliveries or at term of pregnancy OR Women performing an abortion consenting to the collection of their abortion products.
- Having signed a consent
- Affiliated with social security
Key exclusion criteria (4 listed)
- Placental sample or abortion product unavailable (not collected or necessary for treatment).
- Patient with known positive HIV or Hepatitis B or Hepatitis C serology or at risk according to the infectious safety criteria applied by the EFS.
- hemoglobin <7d / dL or hemoglobin <10g / dL if she suffers from a cardio-respiratory pathology).
- Patient protected by law (minor, hospitalized under duress, subject to a legal protection measure by guardianship or curatorship, deprived of liberty by judicial or administrative decision)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HistologyAlso: immunohistochemistryCollect the placenta and fetal membranes and perfor either tissue culture or fixation for further analyses | Diagnostic test | Normal and pathological term, Normal, pathological IVG |
Primary outcome
To better characterize pregnancy pathologies from implantation to childbirth
Time frame: Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hours
Comparison of the frequencies (in percentage) of the histological differences of the placenta and its appendages in patients with pathological and normal pregnancies (histological differences of normal pregnancies versus pathological pregnancies.
1 secondary outcome
Link between the frequencies of histological aberrations and worsening of the pathology
Time frame: Assessement of the link between the frequencies of histological aberrations and worsening of the pathology will be assessed on the final cohort; This will take up to 3 hours for each aberration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Pascale Hoffmann, MD PHD principal investigator
Grenoble hospital
Nadia Alfaidy, PhD study director
INSERM U1292
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-eclampsia and Pre-Term, run by University Hospital, Grenoble.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascale Hoffmann, MD PhD (0476769223, PHoffmann@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To better characterize pregnancy pathologies from implantation to childbirth (time frame: Analyses will be performed on each collected sample. The measurement is assessed for up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2022.