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

This study has been completed.

Sponsor:

Information provided by:

Helse Stavanger HF

ClinicalTrials.gov Identifier:

NCT01201486

First received: September 13, 2010

Last updated: NA

Last verified: September 2010

History: No changes posted

Purpose

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

Condition
Congenital Heart Defects

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester.

Resource links provided by NLM:

MedlinePlus related topics: Congenital Heart Defects

U.S. FDA Resources

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:

Congenital heart defects [ Time Frame: 2nd trimester ] [ Designated as safety issue: No ]

Enrollment:	6781
Study Start Date:	October 2006
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Pregnant women Pregnant females in the 2nd trimester.
Pregnant women in second trimester

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pregnant women for routine examination in the 2nd trimester.

Criteria

Inclusion Criteria:

Pregnant
2nd trimester

Exclusion Criteria:

Unwilling

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201486

Locations

Norway
Stavanger University Hospital
Stavanger, Norway, NO-4011

Sponsors and Collaborators

Helse Stavanger HF

Investigators

Principal Investigator:	Claudia Heien, RN	Helse Stavanger HF
Study Director:	Torbjørn M. Eggebø, MD	Helse Stavanger HF

More Information

Publications:

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.

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

Responsible Party:	Stein Tore Nilsen, PhD, Research Director, Stavanger University Hospital
ClinicalTrials.gov Identifier:	NCT01201486 History of Changes
Other Study ID Numbers:	SUS-CH1
Study First Received:	September 13, 2010
Last Updated:	September 13, 2010
Health Authority:	Norway: Norwegian Social Science Data Services Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Helse Stavanger HF:

Ultrasound
Pregnancy
Fetal heart defects
Color doppler

Additional relevant MeSH terms:

Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013

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