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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01201486
First received: September 13, 2010
Last updated: April 26, 2016
Last verified: April 2016
  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.

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy [ Time Frame: 2nd trimester ] [ Designated as safety issue: No ]
    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.


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.

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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01201486     History of Changes
Other Study ID Numbers: SUS-CH1 
Study First Received: September 13, 2010
Results First Received: August 21, 2015
Last Updated: April 26, 2016
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Data wil not be shared outside the research group. Results are published (see references).

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 August 24, 2016