PP13 and Doppler Study to Predict Preeclampsia

Phase 2

• Conditions: Preeclampsia
• Interventions: Drug: No Drug; Drug: Low molecular weight Heparin; Drug: Progesterone

• Registration Number: NCT00928213
• Lead Sponsor: Ben-Gurion University of the Negev

Brief 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.

Study Timeline

• Status Verified: 2009-06
• Study First Submitted: 2009-06-24
• Study First Submitted QC: 2009-06-24
• Last Update Submitted: 2009-06-24
• Study First Posted: 2009-06-25
• Last Update Posted: 2009-06-25
• Study Start: 2009-08
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	No Drug	Control not treated, no placebo
2	Low molecular weight Heparin	Patient treated with low molecular weight heparin after repeated pregnancy loss
3	Progesterone	Patient super from first trimester bleeding treated with progesterone

Primary Outcome Measures

Name	Time	Method
Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection	pregnancy week >20 till 41 weeks

Secondary Outcome Measures

Name	Time	Method
intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death	fron conception to until a week after delivery

Trial Locations

Locations (1)

Soroka Medical Center, Ben Gurion University; 🇮🇱 Beer-Sheva, Israel