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

NCT ID: NCT01201486

Last Updated: 2016-04-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6781 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Congenital Heart Defects

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women

Pregnant females in the 2nd trimester.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pregnant
* 2nd trimester

Exclusion Criteria

* Unwilling
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudia Heien, RN

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Torbjørn M. Eggebø, MD

Role: STUDY_DIRECTOR

Helse Stavanger HF

Locations

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Stavanger University Hospital

Stavanger, , Norway

Site Status

Countries

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Norway

References

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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. doi: 10.1046/j.1469-0705.1995.05060372.x.

Reference Type BACKGROUND
PMID: 7552797 (View on PubMed)

Chaoui R, McEwing R. Three cross-sectional planes for fetal color Doppler echocardiography. Ultrasound Obstet Gynecol. 2003 Jan;21(1):81-93. doi: 10.1002/uog.5.

Reference Type BACKGROUND
PMID: 12528169 (View on PubMed)

Eggebo 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.

Reference Type RESULT
PMID: 22685669 (View on PubMed)

Other Identifiers

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SUS-CH1

Identifier Type: -

Identifier Source: org_study_id

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