PP13 and Doppler Study to Predict Preeclampsia

June 24, 2009 updated by: Ben-Gurion University of the Negev

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. All comers attending the prenatal testing at GA 10-13.
  2. 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.
  3. Patients who admitted the emergency ObGyn clinic for bleeding during the first trimester and are treated with progesterone.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-Sheva, Israel
        • Soroka Medical Center, Ben Gurion University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Control not treated, no placebo
Drug: No Drug
no treatment
Other Names:
  • No treatment
EXPERIMENTAL: 2
Patient treated with low molecular weight heparin after repeated pregnancy loss
Drug: Low molecular weight Heparin
40-80 mg/day
Other Names:
  • clexan
EXPERIMENTAL: 3
Patient super from first trimester bleeding treated with progesterone
Drug: Progesterone
40 units daily admission
Other Names:
  • Prometrium
  • C-21 steroid hormone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ben-Gurion University of the Negev

Collaborators

Medical University of Graz
Perkin Elmer Inc.
Diagnostic Technologies Ltd.

Investigators

  • Principal Investigator: Reli Hershkovitz, MD, Ben-Gurion University of the Negev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (ESTIMATE)

June 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 25, 2009

Last Update Submitted That Met QC Criteria

June 24, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 972-07-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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