PP13 and Doppler Study to Predict Preeclampsia - Full Text View

Sponsor:	Ben-Gurion University of the Negev
Collaborators:	Diagnostic Technologies Ltd. Perkin Elmer Inc. Medical University of Graz
Information provided by:	Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier:	NCT00928213

Purpose

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.

Condition	Intervention	Phase
Preeclampsia	Drug: Progesterone Drug: Low molecular weight Heparin Drug: No Drug	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners High Blood Pressure

Drug Information available for: Progesterone Heparin

U.S. FDA Resources

Further study details as provided by Ben-Gurion University of the Negev:

Primary Outcome Measures:

Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection [ Time Frame: pregnancy week >20 till 41 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death [ Time Frame: fron conception to until a week after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Control not treated, no placebo	Drug: No Drug no treatment Other Name: 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 Name: clexan
Experimental: 3 Patient super from first trimester bleeding treated with progesterone	Drug: Progesterone 40 units daily admission Other Names: C-21 steroid hormone Prometrium

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.

Eligibility

Ages Eligible for Study:	16 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928213

Contacts

Contact: Reli Hershkovitz, MD	972-8-6403070	ralika@bgu.ac.il
Contact: Vered Kivity, PhD, MBA	972-4-9937722 ext 0	vered.kivity@pregesys.com

Locations

Israel
Soroka Medical Center, Ben Gurion University	Not yet recruiting
Beer-Sheva, Israel
Contact: Reli Hershkovitz, MD 972-8-86403070 ralikah@bgu.ac.il
Contact: Vered Kivity, PhD, MBA 972-4-9937722 vered.kivity@pregenesys.com
Principal Investigator: Reli Hershkovitz, MD

Sponsors and Collaborators

Ben-Gurion University of the Negev

Diagnostic Technologies Ltd.

Perkin Elmer Inc.

Medical University of Graz

Investigators

Principal Investigator:

Reli Hershkovitz, MD

Ben-Gurion University of the Negev

More Information

Additional Information:

The website of Ben Gurion University This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr. Reli Hershkovitz, Soroka Medical Center Ben Gurion University
ClinicalTrials.gov Identifier:	NCT00928213 History of Changes
Other Study ID Numbers:	972-07-024
Study First Received:	June 24, 2009
Last Updated:	June 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ben-Gurion University of the Negev:

Preeclampsia
IUGR
GH
PP13

Doppler
placenta
PTD
Preterm delivery

Additional relevant MeSH terms:

Pre-Eclampsia
Premature Birth
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Progesterone
Anticoagulants

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012