Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01201486
Recruitment Status : Completed
First Posted : September 14, 2010
Results First Posted : April 26, 2016
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease
Congenital Heart Defects

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 6781 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester.
Study Start Date : October 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Pregnant women
Pregnant females in the 2nd trimester.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy [ Time Frame: 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201486


Locations
Layout table for location information
Norway
Stavanger University Hospital
Stavanger, Norway, NO-4011
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Layout table for investigator information
Principal Investigator: Claudia Heien, RN Helse Stavanger HF
Study Director: Torbjørn M. Eggebø, MD Helse Stavanger HF
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01201486    
Other Study ID Numbers: SUS-CH1
First Posted: September 14, 2010    Key Record Dates
Results First Posted: April 26, 2016
Last Update Posted: April 27, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
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:
Layout table for MeSH terms
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities