A cluster randomised controlled trial of selective consent for the second trimester ultrasound sca

Not Applicable

Completed

• Conditions: Second trimester ultrasound scan; Pregnancy and Childbirth

• Registration Number: ISRCTN76982667
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2002-11-20
• Study Start: 2005-11-17
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1466

Inclusion Criteria

1. Pregnant women booked at the Royal Victoria Infirmary (RVI) attending for a 'routine' second trimester anomaly scan
2. Aged 16-50
3. Able to communicate verbally in English

Exclusion Criteria

1. Known twin pregnancy
2. Women who have been given a risk positive result from an earlier scan

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal anxiety two weeks post scan as measured by the State Trait Anxiety Inventory (STAI) (Speilberger, 1983)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Maternal anxiety (STAI) at baseline and immediately following scan<br> 2. Maternal knowledge about the purpose and effectiveness of the second trimester scan<br> 3. Maternal anxiety measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983)<br> 4. Uptake for the 5 separate components of the second trimester scan<br> 5. Maternal anxiety (STAI) following a subnormal result from the second trimester scan at 30 weeks gestation and 6 weeks postnatal<br>