NCT00928213

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Ben-Gurion University of the Negev · Academic / Other
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DRUG	Progesterone	40 units daily admission
DRUG	Low molecular weight Heparin	40-80 mg/day
DRUG	No Drug	no treatment

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-06-25
• Last updated: 2009-06-25

Locations

1 site across 1 country: Israel