PP13 and Doppler Study to Predict Preeclampsia

Preeclampsia Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

• NCT number: NCT00928213
• Study type: Interventional
• Source: Ben-Gurion University of the Negev
• Contact: Reli Hershkovitz, MD
• Phone: 972-8-6403070
• Email: ralika@bgu.ac.il
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: August 2009
• Completion date: December 2010