PP13 and Doppler Study to Predict Preeclampsia
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
1 other identifier
interventional
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 25, 2009
June 1, 2009
1.3 years
June 24, 2009
June 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection
pregnancy week >20 till 41 weeks
Secondary Outcomes (1)
intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death
fron conception to until a week after delivery
Study Arms (3)
1
EXPERIMENTALControl not treated, no placebo
2
EXPERIMENTALPatient treated with low molecular weight heparin after repeated pregnancy loss
3
EXPERIMENTALPatient super from first trimester bleeding treated with progesterone
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ben-Gurion University of the Negevlead
- Diagnostic Technologies Ltd.collaborator
- Perkin Elmer Inc.collaborator
- Medical University of Grazcollaborator
Study Sites (1)
Soroka Medical Center, Ben Gurion University
Beersheba, Israel
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reli Hershkovitz, MD
Ben-Gurion University of the Negev
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 24, 2009
First Posted
June 25, 2009
Study Start
August 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 25, 2009
Record last verified: 2009-06