Optimal timing for fetal structural ultrasound examination: test characteristics of early ultrasound screening at 13-14 weeks using transabdominal and transvaginal ultrasound

Optimal timing for fetal structural ultrasound examination: test characteristics of early ultrasound screening at 13-14 weeks using transabdominal and transvaginal ultrasound - Optimal timing for fetal structural ultrasound examination (OTIS)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40363

Enrollment

2000

Registered

2014-05-21

Start date

2014-07-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital anomalies fetal abnormalities

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Pregnant woman - 18 years of age or older - Participating in second trimester screening - Good knowledge of Dutch or English - Capacity to consent/ good mental competence

Exclusion criteria

Exclusion criteria: - Congenital anomalies seen in previous ultrasound or during first trimester - Oligo-/anhydramnion - Contra-indications for transvaginal ultrasound: patient*s refusal

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of early structural ultrasound compared to normal midterm ultrasound	—

Secondary

Measure	Time frame
Amount of abnormalities seen and not seen at the ultrasound examinations, type of abnormalities and amount of (in-) conclusive examinations and the reasons for being inconclusive	—

Countries

Netherlands

Outcome results