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PP13 and Doppler Study to Predict Preeclampsia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Ben-Gurion University of the Negev.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Diagnostic Technologies Ltd.
Perkin Elmer Inc.
Medical University of Graz
Information provided by:
Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier:
NCT00928213
First received: June 24, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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 2
Phase 3

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:


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:

  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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Hypertension, Pregnancy-Induced
Pregnancy Complications
Dalteparin
Heparin, Low-Molecular-Weight
Progesterone
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014