Clinical trial NCT00928213: PP13 and Doppler Study to Predict Preeclampsia
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Preeclampsia
Keywords: Preeclampsia
IUGR
GH
PP13
Doppler
placenta
PTD
Preterm delivery
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
Collaborators: name: Diagnostic Technologies Ltd.
name: Perkin Elmer Inc.
name: Medical University of Graz
First posted: 2009-06-25
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection
timeFrame: pregnancy week >20 till 41 weeks
Secondary outcomes:
measure: intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death
timeFrame: fron conception to until a week after delivery
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center, Ben Gurion University
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Reli Hershkovitz, MD
role: PRINCIPAL_INVESTIGATOR
References: