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

Congenital Heart Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201486
• Other study ID #: SUS-CH1
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: April 26, 2016
• Start date: October 2006
• Est. completion date: August 2009

Study information

• Verified date: April 2016
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6781
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant

• 2nd trimester

Exclusion Criteria:

• Unwilling

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Chaoui R, McEwing R. Three cross-sectional planes for fetal color Doppler echocardiography. Ultrasound Obstet Gynecol. 2003 Jan;21(1):81-93. Review. — View Citation

Eggebø TM, Heien C, Berget M, Ellingsen CL. Routine use of color Doppler in fetal heart scanning in a low-risk population. ISRN Obstet Gynecol. 2012;2012:496935. doi: 10.5402/2012/496935. Epub 2012 May 20. — View Citation

Tegnander E, Eik-Nes SH, Johansen OJ, Linker DT. Prenatal detection of heart defects at the routine fetal examination at 18 weeks in a non-selected population. Ultrasound Obstet Gynecol. 1995 Jun;5(6):372-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy	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.	2nd trimester	No