Contact information
Type
Scientific
Primary contact
Dr Mark Kilby
ORCID ID
Contact details
Birmingham Women's Hospital
Edgbaston
Birmingham
Birmingham
B15 2TG
United Kingdom
+44 0121 627 2777
m.d.kilby@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0047111222
Study information
Scientific title
Psychosexual factors and well-being in women receiving a specialist ultrasound scan
Acronym
Study hypothesis
How do different ways of providing information about a specialist ultrasound scan (interview, letter, audiotape, and a combination of these) affect accuracy of recall and psychological wellbeing in pregnant women?
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
Other
Trial type
Quality of life
Patient information sheet
Condition
Psychological wellbeing in pregnant women
Intervention
Randomised controlled trial. All women attending the clinic for a specialist scan will be invited to participate in the study. They will be provided with an information sheet outlining the details of the study. Women agreeing to participate will complete a questionnaire before their scan. Participants will be randomly assigned to one of four experimental groups using a pre-arranged randomised schedule. These groups will comprise:
1. A control group - receiving the standard care package of an interview and copy of the scan report
2. In addition to the above, group two will receive an audiotaped copy of the interview
3. In addition to the standard care package of an interview and copy of the scan report, group three will be sent a written summary of their interview
4. In addition to the standard care package, group four will receive both a taped copy of the interview and will be sent a written summary.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. State anxiety measured using the self-report State-Trait Anxiety Inventory (STAI) at baseline and 2 weeks post scan
2. Depression measured using the Beck Depression Inventory (BDI) at baseline and 2 weeks post scan
Secondary outcome measures
Information recall measured using a structured telephone interview 2 weeks post scan.
Overall trial start date
04/05/2000
Overall trial end date
30/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Women with congenital abnormalities of their babies.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
550
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
04/05/2000
Recruitment end date
30/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Birmingham Women's Healthcare NHS Trust
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
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14691993
Publication citations
-
Cope CD, Lyons AC, Donovan V, Rylance M, Kilby MD, Providing letters and audiotapes to supplement a prenatal diagnostic consultation: effects on later distress and recall., Prenat. Diagn., 2003, 23, 13, 1060-1067, doi: 10.1002/pd.747.