PP13 and Doppler Study to Predict Preeclampsia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Progesterone
* Drug: Low molecular weight Heparin
* Drug: No Drug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Control not treated, no placebo | Drug: No Drug<br>* no treatment<br>* Other names: No treatment;|
| Experimental: 2<br>Patient treated with low molecular weight heparin after repeated pregnancy loss | Drug: Low molecular weight Heparin<br>* 40-80 mg/day<br>* Other names: clexan;|
| Experimental: 3<br>Patient super from first trimester bleeding treated with progesterone | Drug: Progesterone<br>* 40 units daily admission<br>* Other names: Prometrium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection |  | pregnancy week >20 till 41 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death |  | fron conception to until a week after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia, IUGR, GH, PP13, Doppler, placenta, PTD, Preterm delivery