Pre-Eclampsia Prediction By Doppler Screening Of Uterine Arteries And Angiogenic Factors In Second Trimester Of Pregnancy

NCT ID: NCT00725660

Last Updated: 2008-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Brief Summary

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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

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Conditions

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Pregnancy Pre Eclampsia

Keywords

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pre eclampsia doppler uterine arteries angiogenic factors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Pregnant women in second trimester that took the routine triple test, and are having an early routine detailed ultrasound examination.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* pregnant women in second trimester that took the routine triple test, and are having an early routine detailed ultrasound examination, in Jerusalem, Israel

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shaare Zedek Medical Center Jerusalem Israel

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Eyal Mazaki, MD

Role: CONTACT

Phone: 972-2-6555555

Email: [email protected]

Facility Contacts

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Eyal Mazaki, MD

Role: primary

Other Identifiers

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0153-08-HMO.CTIL

Identifier Type: -

Identifier Source: org_study_id