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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76982667
Enrollment
1466
Registered
2005-11-17
Start date
2002-01-01
Completion date
Unknown
Last updated
2019-03-18

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

Conditions

Second trimester ultrasound scan Pregnancy and Childbirth

Interventions

1. A structured face to face discussion with a research midwife or research sonographer about the purpose of and effectiveness of the second trimester fetal anomaly scan followed by the opportunity to

Sponsors

Newcastle upon Tyne Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026