Congenital Heart Defects
Conditions
Keywords
Ultrasound, Pregnancy, Fetal heart defects, Color doppler
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
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.
Interventions
None listed
Sponsors
Helse Stavanger HF
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Pregnant * 2nd trimester
Exclusion criteria
* Unwilling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy | 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. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women in Second Trimester Pregnant females in the 2nd trimester. | 6,781 |
| Total | 6,781 |
Baseline characteristics
| Characteristic | Pregnant Women in Second Trimester |
|---|---|
| Age, Continuous | 29 years |
| Sex: Female, Male Female | 6781 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6,781 |
| serious Total, serious adverse events | 0 / 6,781 |
Outcome results
Primary
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.
Time frame: 2nd trimester
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregnant Women | Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy | Major Heart Defects at Delivery | 39 fetuses |
| Pregnant Women | Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy | Heart Defects Detected by Color Dopple | 9 fetuses |
Percentage Sensitivity