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PP13 and Doppler Study to Predict Preeclampsia

Primary Purpose

Preeclampsia

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Progesterone
Low molecular weight Heparin
No Drug
Sponsored by
Ben-Gurion University of the Negev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Preeclampsia focused on measuring Preeclampsia, IUGR, GH, PP13, Doppler, placenta, PTD, Preterm delivery

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Soroka Medical Center, Ben Gurion University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Control not treated, no placebo

Patient treated with low molecular weight heparin after repeated pregnancy loss

Patient super from first trimester bleeding treated with progesterone

Outcomes

Primary Outcome Measures

Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection

Secondary Outcome Measures

intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death

Full Information

First Posted
June 24, 2009
Last Updated
June 24, 2009
Sponsor
Ben-Gurion University of the Negev
Collaborators
Diagnostic Technologies Ltd., Perkin Elmer Inc., Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT00928213
Brief Title
PP13 and Doppler Study to Predict Preeclampsia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ben-Gurion University of the Negev
Collaborators
Diagnostic Technologies Ltd., Perkin Elmer Inc., Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Preeclampsia, IUGR, GH, PP13, Doppler, placenta, PTD, Preterm delivery

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Control not treated, no placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Patient treated with low molecular weight heparin after repeated pregnancy loss
Arm Title
3
Arm Type
Experimental
Arm Description
Patient super from first trimester bleeding treated with progesterone
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
C-21 steroid hormone, Prometrium
Intervention Description
40 units daily admission
Intervention Type
Drug
Intervention Name(s)
Low molecular weight Heparin
Other Intervention Name(s)
clexan
Intervention Description
40-80 mg/day
Intervention Type
Drug
Intervention Name(s)
No Drug
Other Intervention Name(s)
No treatment
Intervention Description
no treatment
Primary Outcome Measure Information:
Title
Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection
Time Frame
pregnancy week >20 till 41 weeks
Secondary Outcome Measure Information:
Title
intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death
Time Frame
fron conception to until a week after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reli Hershkovitz, MD
Phone
972-8-6403070
Email
ralika@bgu.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Vered Kivity, PhD, MBA
Phone
972-4-9937722
Ext
0
Email
vered.kivity@pregesys.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reli Hershkovitz, MD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center, Ben Gurion University
City
Beer-Sheva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reli Hershkovitz, MD
Phone
972-8-86403070
Email
ralikah@bgu.ac.il
First Name & Middle Initial & Last Name & Degree
Vered Kivity, PhD, MBA
Phone
972-4-9937722
Email
vered.kivity@pregenesys.com
First Name & Middle Initial & Last Name & Degree
Reli Hershkovitz, MD

12. IPD Sharing Statement

Links:
URL
http://www.bgu.ac.il
Description
The website of Ben Gurion University

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PP13 and Doppler Study to Predict Preeclampsia

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