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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00928213
• Other study ID #: 972-07-024
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: June 24, 2009
• Last updated: June 24, 2009
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2009
• Source: Ben-Gurion University of the Negev
• Contact: Reli Hershkovitz, MD
• Phone: 972-8-6403070
• Email: ralika[@]bgu.ac.il
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

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

Intervention

Drug:
• Progesterone
40 units daily admission
• Low molecular weight Heparin
40-80 mg/day
• No Drug
no treatment

Locations

Country	Name	City	State
Israel	Soroka Medical Center, Ben Gurion University	Beer-Sheva

Sponsors (4)

Lead Sponsor	Collaborator
Ben-Gurion University of the Negev	Diagnostic Technologies Ltd., Medical University of Graz, Perkin Elmer Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection		pregnancy week >20 till 41 weeks	No
Secondary	intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death		fron conception to until a week after delivery	No

External Links

•   The website of Ben Gurion University