PP13 and Doppler Study to Predict Preeclampsia

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ben-Gurion University of the Negev
• Collaborators: Diagnostic Technologies Ltd.; Medical University of Graz; Perkin Elmer Inc.
• Treatments: Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Progesterone; Tinzaparin

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