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Sponsor study identifier
observational
3,000
1 country
1
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedBACKGROUND: Pre-eclampsia complicates about 2% of pregnancies. It accounts for at least 50 000 maternal deaths per year worldwide and is the second most common cause of maternal death in the developing world. Also, Pre-eclampsia is the commonest cause of iatrogenic prematurity, It frequently coexists with intrauterine growth restriction (IUGR) and placental abruption, other important causes of adverse prenatal outcome. There have been many studies investigating whether the disease can be prevented. In order to achieve this, one needs to be able to identify firstly those women that are at highest risk of the disease. Early studies showed that impedance to flow in the uterine arteries decreases with gestation in normal pregnancies, while in pregnancies with established pre-eclampsia or IUGR the impedance is increased. These observations led to a number of screening studies in the second trimester, which assessed if it is possible to predict those pregnancies destined to have complications of impaired placentation. These studies showed that women with increased impedance to uterine artery blood flow have an increased risk of developing pre-eclampsia, and detection can be further increased by using angiogenic factors (That are involved in the pathogenesis of Pre- eclampsia and could be useful for early prediction of the disease: VEGF, PIGF, PP13, sFLT1) in combination with uterine arteries Doppler study in the second trimester. METHODS: In this study we would like to add uterine arteries Doppler to the early routine detailed ultrasound examination (14-16 weeks), in 3000 women in Jerusalem. in addition we would like to check angiogenic factors from the serum blood taken for the routine triple test in these women (16-18 weeks).pregnancy outcome would be collected after labour from the medical centers participating in this research.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2008
Actual (reported)July 30, 2008
Actual (reported)September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Pregnant women in second trimester that took the routine triple test, and are having an early routine detailed ultrasound examination.
Pregnant women in second trimester that took the routine triple test, and are having an early routine detailed ultrasound examination, in Jerusalem, Israel.
Shaare Zedek Medical Center
Jerusalem, Israel
First Submitted
July 29, 2008
First Posted
July 30, 2008
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
July 30, 2008
Record last verified: 2008-07
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Source: ClinicalTrials.gov.
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