Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester

Completed

• Conditions: Congenital Heart Defects

• Registration Number: NCT01201486
• Lead Sponsor: Helse Stavanger HF

Brief Summary

To evaluate the percentage of severe heart defect diagnosed with the use of color Doppler at a routine fetal scan in the second trimester of pregnancy

Detailed Description

Almost all women in Norway have a routine ultrasound examination in the second trimester, however, the detection rate of heart defect are only around 50%. In this study we use color Doppler at three different levels in the fetal heart; the four chamber view, the outlet of the aorta on on the level of the great arteries.

All heart defects at delivery are recorded and compared with the ultrasound findings.

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Results First Submitted: 2015-08-21
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-25
• Results First Posted: 2016-04-26
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6781

Inclusion Criteria

• Pregnant
• 2nd trimester

Exclusion Criteria

• Unwilling

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy	2nd trimester	The number of \*fetuses with\* heart defects detected by color Doppler in the second trimester was compared to the number of \*fetuses with\* major heart defects detected at birth.

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Norway