Study of the Physiology of Pre-eclampsia and Vascular IUGR With Constitution of a Biological Collection (CPVP)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03626233 |
|
Recruitment Status :
Recruiting
First Posted : August 10, 2018
Last Update Posted : December 21, 2022
|
Sponsor:
Centre Hospitalier Intercommunal Creteil
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | August 8, 2018 | ||||||||
| First Posted Date | August 10, 2018 | ||||||||
| Last Update Posted Date | December 21, 2022 | ||||||||
| Actual Study Start Date | August 6, 2018 | ||||||||
| Estimated Primary Completion Date | August 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
genomic analysis on placenta [ Time Frame: day of delivery ] by chromatin immunoprecipitation-sequencing (ChIP-seq)
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Study of the Physiology of Pre-eclampsia and Vascular IUGR With Constitution of a Biological Collection | ||||||||
| Official Title | Study of the Physiology of Pre-eclampsia and Vascular Intrauterine Growth Restriction With Constitution of a Biological Collection | ||||||||
| 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 | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 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
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | pregnant women with or without vascular pathology | ||||||||
| Condition | Pre-Eclampsia | ||||||||
| Intervention | Other: collect of placenta, blood and urinary samples at delivery
collect of placenta, blood and urinary samples at delivery
|
||||||||
| Study Groups/Cohorts |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | April 2024 | ||||||||
| Estimated Primary Completion Date | August 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03626233 | ||||||||
| Other Study ID Numbers | CPVP | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement |
|
||||||||
| Current Responsible Party | Centre Hospitalier Intercommunal Creteil | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Centre Hospitalier Intercommunal Creteil | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
||||||||
| PRS Account | Centre Hospitalier Intercommunal Creteil | ||||||||
| Verification Date | December 2022 | ||||||||