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

NCT01201486 | Completed Results

• 1 other identifier: SUS-CH1
• Study Type: observational
• Target: 6,781
• Locations: 1 country
• Sites: 1

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

Conditions

Congenital Heart Defects

Keywords

Ultrasound; Pregnancy; Fetal heart defects; Color doppler

Outcome Measures

Primary Outcomes (1)

• Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy

  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

Study Arms (1)

Pregnant women

Pregnant females in the 2nd trimester.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women for routine examination in the 2nd trimester.

You may qualify if:

• Pregnant
• nd trimester

You may not qualify if:

• Unwilling

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, NO-4011, Norway

Location

Related Publications (3)

• 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.

  PMID: 7552797 BACKGROUND

• 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.

  PMID: 12528169 BACKGROUND

• 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.

  PMID: 22685669 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Torbjørn Moe Eggebø, phd
• Organization: StavangerUH

tme@lyse.net

004792699433

Study Officials

• Claudia Heien, RN

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

• Torbjørn M. Eggebø, MD

  Helse Stavanger HF

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Study Start: October 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 27, 2016
• Results First Posted: April 26, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)