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

ISRCTN ISRCTN76982667
DOI https://doi.org/10.1186/ISRCTN76982667
Secondary identifying numbers N/A
Submission date
07/09/2005
Registration date
17/11/2005
Last edited
21/02/2019
Recruitment status
No longer recruiting
Overall study status
Stopped
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Steven Robson
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Scientific titleA cluster randomised controlled trial of selective consent for the second trimester ultrasound scan
Study acronymUSS & You
Study objectivesWomen 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSecond trimester ultrasound scan
Intervention1. 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 typeOther
Primary outcome measureMaternal anxiety two weeks post scan as measured by the State Trait Anxiety Inventory (STAI) (Speilberger, 1983)
Secondary outcome measures1. 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 study start date01/01/2002
Completion date20/11/2002
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants1466
Key inclusion criteria1. 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
Key exclusion criteria1. Known twin pregnancy
2. Women who have been given a risk positive result from an earlier scan
Date of first enrolment01/01/2002
Date of final enrolment20/11/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Obstetrics and Gynaecology
Newcastle upon Tyne
NE1 7RU
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

University/education

University of Newcastle upon Tyne (UK) - an own account trial

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

21/02/2019: Internal review.
26/05/2016: Received notification that study has been abandoned
25/05/2016: No publications found, verifying study status with principal investigator