PP13 and Doppler Study to Predict Preeclampsia

Sponsor

Ben-Gurion University of the Negev (Other)

Overall Status

Unknown status

CT.gov ID

NCT00928213

Collaborator

Diagnostic Technologies Ltd. (Industry), Perkin Elmer Inc. (Industry), Medical University of Graz (Other)

1,000

Enrollment

Location

Arms

Duration (Months)

62.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia	Drug: Progesterone Drug: Low molecular weight Heparin Drug: No Drug	Phase 2/Phase 3

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:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

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 :

Aug 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Control not treated, no placebo	Drug: No Drug no treatment Other Names: No treatment
Experimental: 2 Patient treated with low molecular weight heparin after repeated pregnancy loss	Drug: Low molecular weight Heparin 40-80 mg/day Other Names: clexan
Experimental: 3 Patient super from first trimester bleeding treated with progesterone	Drug: Progesterone 40 units daily admission Other Names: C-21 steroid hormone Prometrium

Arm

Intervention/Treatment

Experimental: 1

Control not treated, no placebo

Drug: No Drug

no treatment

Other Names:

No treatment

Experimental: 2

Patient treated with low molecular weight heparin after repeated pregnancy loss

Drug: Low molecular weight Heparin

40-80 mg/day

Other Names:

clexan

Experimental: 3

Patient super from first trimester bleeding treated with progesterone

Drug: Progesterone

40 units daily admission

Other Names:

C-21 steroid hormone

Prometrium

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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