PP13 and Doppler Study to Predict Preeclampsia
|ClinicalTrials.gov Identifier: NCT00928213|
Recruitment Status : Unknown
Verified June 2009 by Ben-Gurion University of the Negev.
Recruitment status was: Not yet recruiting
First Posted : June 25, 2009
Last Update Posted : June 25, 2009
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 or disease||Intervention/treatment||Phase|
|Preeclampsia||Drug: Progesterone Drug: Low molecular weight Heparin Drug: No Drug||Phase 2 Phase 3|
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:
- All comers attending the prenatal testing at GA 10-13.
- 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.
- Patients who admitted the emergency ObGyn clinic for bleeding during the first trimester and are treated with progesterone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2010|
Control not treated, no placebo
Drug: No Drug
Other Name: No treatment
Patient treated with low molecular weight heparin after repeated pregnancy loss
Drug: Low molecular weight Heparin
Other Name: clexan
Patient super from first trimester bleeding treated with progesterone
40 units daily admission
- Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection [ Time Frame: pregnancy week >20 till 41 weeks ]
- intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death [ Time Frame: fron conception to until a week after delivery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928213
|Contact: Reli Hershkovitz, MDfirstname.lastname@example.org|
|Contact: Vered Kivity, PhD, MBA||972-4-9937722 ext email@example.com|
|Soroka Medical Center, Ben Gurion University||Not yet recruiting|
|Contact: Reli Hershkovitz, MD 972-8-86403070 firstname.lastname@example.org|
|Contact: Vered Kivity, PhD, MBA 972-4-9937722 email@example.com|
|Principal Investigator: Reli Hershkovitz, MD|
|Principal Investigator:||Reli Hershkovitz, MD||Ben-Gurion University of the Negev|