Condition category
Pregnancy and Childbirth
Date applied
07/09/2005
Date assigned
17/11/2005
Last edited
26/05/2016
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

Prof Steven Robson

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
3rd Floor
William Leech Building
University of Newcastle upon Tyne
Claremont Road
Newcastle upon Tyne
NE1 7RU
United Kingdom

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

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Trust (UK)

Sponsor details

Research and Development
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes

26/05/2016: Recieved notification that study has been abandoned 25/05/2016: No publications found, verifying study status with principal investigator