Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes

27/11/2015: Publication reference and outcome measures added.