Establishing First Trimester Markers for the Identification of High Risk Twin

Pre-Eclampsia Clinical Trial

Official title:

Establishing First Trimester Sonographic, Biochemical and Clinical Markers for the Identification of High Risk Twin in the First Trimester

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02031393
• Other study ID #: 217/13
• Status: Active, not recruiting
• Phase: N/A
• First received: January 8, 2014
• Last updated: January 30, 2014
• Start date: September 2009
• Est. completion date: July 2014

Study information

• Verified date: December 2013
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• pregnant women from 11 -14 weeks of gestation

Exclusion Criteria:

• nuchal thickness above 3 mm,

• Chronic hypertension,

• thrombophilia,

• Diabetes

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Small for Gestational Age (Disorder)

Locations

Country	Name	City	State
Israel	Assaf Harofe obstetric department	Be'er Ya`aqov	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The development of preeclampsia	the women will be approached after birth to asses whether they developed preeclampsia or pregnancy induced hypertension	after delivery	No
Secondary	intra uterine growth restriction		after delivery	No