Pre-EclampsiaCPVPNCT03626233
Study of the Physiology of Pre-eclampsia and Vascular IUGR With Constitution of a Biological Collection
An observational study of Pre-Eclampsia, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Preeclampsia and intrauterine growth retardation (IUGR) are serious and frequent pathologies, specific to pregnancy. They represent 70 000 new cases a year, or 9% of pregnancies and cause 50,000 premature births per year in France. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- collect of placenta, blood and urinary samples at delivery
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 6 Aug 2018to Aug 2028
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pregnant women with or without vascular pathology
Who may be able to join
- pregnant women
- With or without vascular pathology
Who cannot join
- refusal to participate
- multiple pregnancy
- major fetal malformation diagnosed during pregnancy follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHi Creteil
Créteil, 94000
Diane REDEL, 145175530 ext. 0033, diane.redel@chicreteil.fr
Edouard LECARPENTIER, MD PhD
About this study
Official title: Study of the Physiology of Pre-eclampsia and Vascular Intrauterine Growth Restriction With Constitution of a Biological Collection
Preeclampsia and intrauterine growth retardation (IUGR) are serious and frequent pathologies, specific to pregnancy. They represent 70 000 new cases a year, or 9% of pregnancies and cause 50,000 premature births per year in France. The consequences in terms of morbidity and perinatal morbidity and the medical and economic costs make it an issue public health. Pre-eclampsia associates maternal hypertension with dysfunction kidney. There is no cure for pre-eclampsia or IUGR vascular during pregnancy. These pathologies invariably evolve towards a maternal and / or fetal aggravation sometimes very fast. Primary prevention and secondary education and screening for these pathologies are still insufficient. A better understanding of the pathophysiology of these placental vascular pathologies is necessary for the development of supported medical, obstetric and pediatric that will improve the state of health maternal and neonatal
- Conditions
- Pre-Eclampsia
- Being tested
- collect of placenta, blood and urinary samples at delivery
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect of placenta, blood and urinary samples at deliveryOther
collect of placenta, blood and urinary samples at delivery
| Study group | Role | What they receive |
|---|---|---|
| Vascular group | Pregnant women with vascular pathology Receives: Other: collect of placenta, blood and urinary samples at delivery | |
| Control group | * Pregnancy without any vascular complication
* Delivery before or after 37 weeks of gestation (GW)
* In case of delivery after 37GW: birth by cesarean delivery Receives: Other: collect of placenta, blood and urinary samples at delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
genomic analysis on placenta
by chromatin immunoprecipitation-sequencing (ChIP-seq)
Measured: day of delivery
Secondary outcomes (6)
genomic analysis on blood
by ChIP-seq
Measured: day of delivery
genomic analysis on placenta
by immunohistochemistry an polymerase chain-reaction
Measured: day of delivery
VEGF blood level
Measured: day of delivery
PLGF blood level
Measured: day of delivery
sFlt1 blood level
Measured: day of delivery
sKDR blood level
Measured: day of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start6 Aug 2018
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (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.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard Lecarpentier, MD PhD, Principal investigator, CHI CRETEIL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626233
- Sponsor's protocol ID
- CPVP
- Acronym
- CPVP
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2018
- Last updated
- 12 Jun 2026
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Physiology of Pre-eclampsia and Vascular Intrauterine Growth Restriction With Constitution of a Biological Collection
- ClinicalTrials.gov ID
- NCT03626233
- Acronym / sponsor ID
- CPVP / CPVP
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 10 Aug 2018 (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.
Preeclampsia and intrauterine growth retardation (IUGR) are serious and frequent pathologies, specific to pregnancy. They represent 70 000 new cases a year, or 9% of pregnancies and cause 50,000 premature births per year in France. The consequences in terms of morbidity and perinatal morbidity and the medical and economic costs make it an issue public health. Pre-eclampsia associates maternal hypertension with dysfunction kidney. There is no cure for pre-eclampsia or IUGR vascular during pregnancy. These pathologies invariably evolve towards a maternal and / or fetal aggravation sometimes very fast. Primary prevention and secondary education and screening for these pathologies are still insufficient. A better understanding of the pathophysiology of these placental vascular pathologies is necessary for the development of supported medical, obstetric and pediatric that will improve the state of health maternal and neonatal
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascular group | – | Other: collect of placenta, blood and urinary samples at deliveryPregnant women with vascular pathology |
| Control group | – | Other: collect of placenta, blood and urinary samples at delivery* Pregnancy without any vascular complication * Delivery before or after 37 weeks of gestation (GW) * In case of delivery after 37GW: birth by cesarean delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women with or without vascular pathology
Key inclusion criteria (2 listed)
- pregnant women
- With or without vascular pathology
Key exclusion criteria (3 listed)
- refusal to participate
- multiple pregnancy
- major fetal malformation diagnosed during pregnancy follow-up
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 |
|---|---|---|
| collect of placenta, blood and urinary samples at deliverycollect of placenta, blood and urinary samples at delivery | Other | Control group, Vascular group |
Primary outcome
genomic analysis on placenta
Time frame: day of delivery
by chromatin immunoprecipitation-sequencing (ChIP-seq)
6 secondary outcomes
genomic analysis on blood
Time frame: day of delivery
genomic analysis on placenta
Time frame: day of delivery
VEGF blood level
Time frame: day of delivery
PLGF blood level
Time frame: day of delivery
sFlt1 blood level
Time frame: day of delivery
sKDR blood level
Time frame: day of delivery
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 Jun 2026.
- Individual participant dataSharing planned: No
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Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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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.
Edouard Lecarpentier, MD PhD principal investigator
CHI CRETEIL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Centre Hospitalier Intercommunal Creteil at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Diane REDEL (145175530 ext. 0033, diane.redel@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genomic analysis on placenta (time frame: day of delivery). 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 Jun 2026.