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

• Conditions: congenital anomalies; 10016849; fetal abnormalities

• Registration Number: NL-OMON40363
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 2000

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

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity and specificity of early structural ultrasound compared to normal<br /><br>midterm ultrasound</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Amount of abnormalities seen and not seen at the ultrasound examinations, type<br /><br>of abnormalities and amount of (in-) conclusive examinations and the reasons<br /><br>for being inconclusive</p><br>