Study of the Physiology of Pre-eclampsia and Vascular Intrauterine Growth Restriction With Constitution of a Biological Collection

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



Sponsors


Source

Centre Hospitalier Intercommunal Creteil

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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

Overall Status

Recruiting

Start Date

2018-08-06

Completion Date

2024-04-01

Primary Completion Date

2023-08-01

Study Type

Observational

Primary Outcome

Measure

Time Frame

genomic analysis on placenta
day of delivery

Secondary Outcome

Measure

Time Frame

genomic analysis on blood
day of delivery
genomic analysis on placenta
day of delivery
VEGF blood level
day of delivery
PLGF blood level
day of delivery
sFlt1 blood level
day of delivery
sKDR blood level
day of delivery

Number Of Groups

2

Enrollment

500

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

collect of placenta, blood and urinary samples at delivery

Arm Group Label

Vascular group

Control group



Eligibility

Study Pop

pregnant women with or without vascular pathology

Sampling Method

Non-Probability Sample

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

Gender

Female

Gender Based

Yes

Gender Description

Pregnant women

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Edouard Lecarpentier, MD PhD
Principal Investigator
CHI Creteil

Overall Contact

Last Name

Diane REDEL

Phone

145175530

Phone Ext

0033

Email



Location

Facility

Status

Contact

Investigator

CHi Creteil
Creteil 94000 France
Recruiting
Last Name: Diane REDEL
Phone: 145175530
Phone Ext: 0033
Email: [email protected]
Last Name: Edouard LECARPENTIER, MD PhD
Role: Principal Investigator

Location Countries

Country

France


Verification Date

2018-08-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Vascular group

Description

Pregnant women with vascular pathology


Arm Group Label

Control group

Description

Pregnancy without any vascular complication
Delivery before or after 37 weeks of gestation (GW)
In case of delivery after 37GW: birth by cesarean delivery



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

camille Jung

Phone

157022268

Phone Ext

0033

Email



Biospec Retention

Samples With DNA

Biospec Descr

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

Acronym

CPVP

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

August 8, 2018

Study First Submitted Qc

August 8, 2018

Study First Posted

August 10, 2018

Last Update Submitted

August 8, 2018

Last Update Submitted Qc

August 8, 2018

Last Update Posted

August 10, 2018


ClinicalTrials.gov processed this data on August 10, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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