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Study of the Physiology of Pre-eclampsia and Vascular IUGR With Constitution of a Biological Collection (CPVP)

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ClinicalTrials.gov Identifier: NCT03626233
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Study Description
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Brief 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. 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

Condition or disease Intervention/treatment
Pre-Eclampsia Other: collect of placenta, blood and urinary samples at delivery

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Physiology of Pre-eclampsia and Vascular Intrauterine Growth Restriction With Constitution of a Biological Collection
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Vascular group
Pregnant women with vascular pathology
 Other: collect of placenta, blood and urinary samples at delivery
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
 Other: collect of placenta, blood and urinary samples at delivery
collect of placenta, blood and urinary samples at delivery


Outcome Measures
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Primary Outcome Measures :
  1. genomic analysis on placenta [ Time Frame: day of delivery ]
    by chromatin immunoprecipitation-sequencing (ChIP-seq)


Secondary Outcome Measures :
  1. genomic analysis on blood [ Time Frame: day of delivery ]
    by ChIP-seq

  2. genomic analysis on placenta [ Time Frame: day of delivery ]
    by immunohistochemistry an polymerase chain-reaction

  3. VEGF blood level [ Time Frame: day of delivery ]
  4. PLGF blood level [ Time Frame: day of delivery ]
  5. sFlt1 blood level [ Time Frame: day of delivery ]
  6. sKDR blood level [ Time Frame: day of delivery ]

Biospecimen Retention:   Samples With DNA
Blood samples for maternal DNA sequencing and angiogenic factors (VEGF, PLGF, sFLt-1, sQDR) Urinary samples: Angiogenic factors Placenta: for placenta DNA sequencing and angiogenic factors

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant women with or without vascular pathology
Criteria

Inclusion Criteria:

  • pregnant women
  • With or without vascular pathology

Exclusion Criteria:

  • refusal to participate
  • multiple pregnancy
  • major fetal malformation diagnosed during pregnancy follow-up
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626233


Contacts
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Contact: Diane REDEL 145175530 ext 0033 diane.redel@chicreteil.fr
Contact: camille Jung 157022268 ext 0033 camille.jung@chicreteil.fr

Locations
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France
CHi Creteil Recruiting
Creteil, France, 94000
Contact: Diane REDEL    145175530 ext 0033    diane.redel@chicreteil.fr   
Principal Investigator: Edouard LECARPENTIER, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Investigators
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Principal Investigator: Edouard Lecarpentier, MD PhD CHI Creteil
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03626233    
Other Study ID Numbers: CPVP
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
 Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases