NCT01261351

Brief Summary

The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

4.1 years

First QC Date

October 26, 2010

Last Update Submit

December 17, 2014

Conditions

Pre Eclampsia

Keywords

Pre eclampsiaEndogenous thrombin potential

Outcome Measures

Primary Outcomes (1)

  • Endogenous thrombin potential

    comparison of Endogenous thrombin potential between patients with Preclampsia (PE) (at the moment of the diagnosis of PE) compared to control (at the same gestational age)

    at preeclampsia diagnosis

Secondary Outcomes (3)

  • genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1

    at pre eclampsia diagnosis

  • In preeclampsia group : correlation between biological markers and severity of the disease

    at the diagnosis of preeclampsia

  • evolution of endogenous thrombin potential in women with preeclampsia

    between the diagnosis of preeclampsia and day 2 of the post partum period

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women from two University hospitals in France

You may qualify if:

  • years old
  • diagnosis of pre eclampsia

You may not qualify if:

  • multiple pregnancy
  • less than 18 year old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Lille

Lille, Nord, 59037, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Maternal blood and urine * cord blood

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Véronique Houfflin Debarge, PHD

    Universituy Hospital Of Lille, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2010

First Posted

December 16, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

FR(1)