Detecting Early Onset Pre-eclampsia and Use of Placental... | NCT01387776

Studies
Detecting Early Onset Pre-eclampsia and Use of Placental Growth Factor (PlGF) for Marker of Trisomy 21

NCT01387776

Sponsor

Clinique Ovo

Status

Terminated

Last Update Posted

Jul 28, 2015Estimated

Enrollment

370Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The technique has been approved and validated

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jan 31, 2011

First Submission Date that Met QC Criteria

Jul 5, 2011

First Posted Date

Jul 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2015

Last Update Posted Date

Jul 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a study for the evaluation of the benefits of 1 st Trimester risk markers in detecting Early Onset Pre-eclampsia and the use of the Placental Growth factor(PIGF) as a potential marker for Trisomy 21 and other aneuploidies.

Aim of this prospective nonprofit study is to analyze the benefits of early onset pre eclampsia risk assessment in the 1st trimester (measuring biochemical markers [PIGF], blood pressure and Doppler ultrasound), and how the results can permit to modify or influence the course of the preeclampsia during the pregnancy. The investigators will also evaluate the potential use of the PIGF as a marker to improve the prenatal screening with the currently used nuchal translucency, serum Pregnancy-associated plasma protein A (PAPP-A) and free beta subunit of human chorionic gonadotropin (fBhCG) parameters.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

370Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group		patients coming to clinique OVO in the 1st trimester of pregnancy to undergo prenatal screening

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
levels of Placental Protein 13 (PP13) , PIGF, PAPP-A, PIBF	levels of PP13, PIGF, PAPP-A will de considered in association with Doppler ultrasound and standardised blood pressure measurements to see if they can be used as early risk markers in patients having a delivery before 34 weeks gestation	6-13.6 wks gestation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton pregnancy
Nulliparous pregnancy
Gestation age between 6.0-13.6 weeks by last menstrual period verified by ultrasound
Blood sample provided at gestational age 6.0-13.6 weeks
Informed Consent

Exclusion Criteria:

Multi-fetal pregnancy
Primiparous or multiparous pregnancy
Mental retardation or other mental disorders that impose doubts regarding the true patient's willingness to participate in the study
Gestation age below 6.0 or above 13.6 weeks by last menstrual period verified by ultrasound.
Lack of blood sample at the specified enrollment period
Known major fetal anomaly or fetal demise
Lack of demographic data

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

women in 1st trimester of pregnancy coming to clinique OVO for prenatal screening

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Hemmings, MD	Clinique Ovo	Principal Investigator
Bernard Couturier, MD	Clinique Ovo	Study Director
Dominique Berube, PhD	Clinique Ovo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OVO Prénatal		Montreal	Quebec	H4P2S4	Canada