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

April 26, 2016 updated by: Helse Stavanger HF

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

6781

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, NO-4011
        • Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women for routine examination in the 2nd trimester.

Description

Inclusion Criteria:

  • Pregnant
  • 2nd trimester

Exclusion Criteria:

  • Unwilling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2nd trimester

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 2010

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUS-CH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data wil not be shared outside the research group. Results are published (see references).

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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