PP13 and Doppler Study to Predict Preeclampsia | NCT00928213

Studies
PP13 and Doppler Study to Predict Preeclampsia

NCT00928213

Sponsor

Ben-Gurion University of the Negev

Status

Unknown status

Last Update Posted

Jun 25, 2009Estimated

Enrollment

1,000Estimated

Phase

Phase 2Phase 3

Conditions

Preeclampsia

Interventions

Progesterone
Low molecular weight Heparin
No Drug

Countries

Israel

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

Official Title

Combined Sonographic Examination and Placenta Protein 13 (PP13) to Compare the Risk for Development of Preeclampsia Among Among Pregnant Women With and Without a History of Preterm Delivery and Those Treated by Progesterone or Clexane

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jun 24, 2009

First Submission Date that Met QC Criteria

Jun 24, 2009

First Posted Date

Jun 25, 2009Estimated

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

Jun 24, 2009

Last Update Posted Date

Jun 25, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Ben-Gurion University of the NegevOTHER

Collaborators

Name	Class
Diagnostic Technologies Ltd.	INDUSTRY
Perkin Elmer Inc.	INDUSTRY
Medical University of Graz	OTHER

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

Assessment of biochemical and sonographic marker to predict the risk for developing preeclampsia Among biochemical markers are serum level of Placental Protein 13 (PP13) and Placenta Growth factor (PIGF). For sonographic marker Doppler pulsatility Index of the blood flow through the uterine maternal arteries is assessed.

PP13 is produced by the placenta and released to the maternal blood circulation. It has been shown to be an effective serum marker for early onset preeclampsia (Nicolaides KH et al., 2005). The purpose of this study is to combined the assessment of the biochemical markers with Doppler in the first and the second trimester to provide a comprehensive evaluation of various methods for sequential and combined analysis to assess the risk for developing preeclampsia.

Detailed Description

This is a prospective observational study enrolling all comers who attend the prenatal clinic for first trimester assessment of the risk for Down syndrome. All women are providing medical and obstetric history, demography and blood samples along with Doppler pulsatility Index during the first and the second trimester at GA 10-13 weeks and 21-23 weeks. When possible - blood will be drawn at hospital admission for delivery. Measurements of sonography and serum markers are done blinded to pregnancy outcome.

Patients will be assigned to three groups:

All comers attending the prenatal testing at GA 10-13.
Patients with a history of at least 2 pregnancy loss or preterm delivery and treated with low molecular weight heparin at 40-80 mg/day from admission to until 12 weeks after delivery.
Patients who admitted the emergency ObGyn clinic for bleeding during the first trimester and are treated with progesterone.

Design Module

Study Type

Interventional

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Control not treated, no placebo	Drug: No Drug
2	Experimental	Patient treated with low molecular weight heparin after repeated pregnancy loss	Drug: Low molecular weight Heparin
3	Experimental	Patient super from first trimester bleeding treated with progesterone	Drug: Progesterone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progesterone	Drug	40 units daily admission	3	C-21 steroid hormone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection		pregnancy week >20 till 41 weeks

Secondary Outcomes

Measure	Description	Time Frame
intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death		fron conception to until a week after delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women age 16-45 with viable pregnancy as defined by CRL and after signing on an informed consent
In group 1 all patients meeting the above are eligible when GA is below 14 weeks
In grop 2 all patients

Exclusion Criteria:

Gestation age at enrolment > 13 weeks and 6 days by LMP verified by ultrasound at blood taking
Mental retardation or other mental disorders that impose doubts regarding the patient's true willingness to participate in the Study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reli Hershkovitz, MD	Contact	972-8-6403070		ralika@bgu.ac.il
Vered Kivity, PhD, MBA	Contact	972-4-9937722	0	vered.kivity@pregesys.com

Overall Officials

Name	Affiliation	Role
Reli Hershkovitz, MD	Ben-Gurion University of the Negev	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka Medical Center, Ben Gurion University		Beersheba			Israel

References Module

Citations

Not provided

ID	Term
D011225	Pre-Eclampsia
D047928	Premature Birth

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D011374	Progesterone
D006495	Heparin, Low-Molecular-Weight

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473