Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A cluster randomised controlled trial of selective consent for the second trimester ultrasound scan
Acronym
USS & You
Study hypothesis
Women given detailed information about the content and effectiveness of the second trimester fetal abnormality scan would experience no additional anxiety after their scan than women given standard information and care.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Second trimester ultrasound scan
Intervention
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 accept or decline 5 separate components of the procedure
2. Standard information and care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Maternal anxiety two weeks post scan as measured by the State Trait Anxiety Inventory (STAI) (Speilberger, 1983)
Secondary outcome measures
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
Overall trial start date
01/01/2002
Overall trial end date
20/11/2002
Reason abandoned
Objectives no longer viable
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1466
Participant exclusion criteria
1. Known twin pregnancy
2. Women who have been given a risk positive result from an earlier scan
Recruitment start date
01/01/2002
Recruitment end date
20/11/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Obstetrics and Gynaecology
Newcastle upon Tyne
NE1 7RU
United Kingdom
Funders
Funder type
University/education
Funder name
University of Newcastle upon Tyne (UK) - an own account trial
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary