PP13 and Doppler Study to Predict Preeclampsia

Ben-Gurion University of the Negev

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Preeclampsia

Treatments: Drug: Progesterone; Drug: Low molecular weight Heparin; Drug: No Drug

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00928213

972-07-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 3 patient groups

1

Experimental group

Description:

Control not treated, no placebo

Treatment:

Drug: No Drug

2

Experimental group

Description:

Patient treated with low molecular weight heparin after repeated pregnancy loss

Treatment:

Drug: Low molecular weight Heparin

3

Experimental group

Description:

Patient super from first trimester bleeding treated with progesterone

Treatment:

Drug: Progesterone