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

Pregnancy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00725660
• Other study ID #: 0153-08-HMO.CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: July 29, 2008
• Last updated: July 29, 2008
• Start date: September 2008

Study information

• Verified date: July 2008
• Source: Shaare Zedek Medical Center
• Contact: Eyal Mazaki, MD
• Phone: 972-2-6555555
• Email: eyalmazaki[@]hotmail.com
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Eclampsia
• Pre Eclampsia
• Pre-Eclampsia
• Pregnancy

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel,