Pre-Eclampsia Prediction By Doppler Screening Of Uterine Arteries And Angiogenic Factors In Second Trimester Of Pregnancy
Recruitment status was: Not yet recruiting
|First Received Date ICMJE||July 29, 2008|
|Last Updated Date||July 29, 2008|
|Start Date ICMJE||September 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Pre-Eclampsia Prediction By Doppler Screening Of Uterine Arteries And Angiogenic Factors In Second Trimester Of Pregnancy|
|Official Title ICMJE||Not Provided|
BACKGROUND: 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.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
|Study Population||Pregnant women in second trimester that took the routine triple test, and are having an early routine detailed ultrasound examination, in Jerusalem, Israel.|
|Intervention ICMJE||Not Provided|
Pregnant women in second trimester that took the routine triple test, and are having an early routine detailed ultrasound examination.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||3000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Israel|
|Removed Location Countries|
|NCT Number ICMJE||NCT00725660|
|Other Study ID Numbers ICMJE||0153-08-HMO.CTIL|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||DR. Eyal Mazaki, Shaare Zedek Medical Center Jerusalem Israel|
|Study Sponsor ICMJE||Shaare Zedek Medical Center|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||Shaare Zedek Medical Center|
|Verification Date||July 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP