Trial | NCT00928213  Report issue

Title

PP13 and Doppler Study to Predict Preeclampsia
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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    1000
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.
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 Started
Aug 31
2009
Primary Completion
Dec 31
2010
Anticipated
Study Completion
Dec 31
2010
Anticipated
Last Update
Jun 25
2009
Estimate

Drug Progesterone

40 units daily admission

  • Other names: C-21 steroid hormone, Prometrium

Drug Low molecular weight Heparin

40-80 mg/day

  • Other names: clexan

Drug No Drug

no treatment

  • Other names: No treatment

1 Experimental

Control not treated, no placebo

2 Experimental

Patient treated with low molecular weight heparin after repeated pregnancy loss

3 Experimental

Patient super from first trimester bleeding treated with progesterone

Criteria 

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
No Results Posted