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

ISRCTN	ISRCTN76982667
DOI	https://doi.org/10.1186/ISRCTN76982667
Protocol serial number	N/A
Sponsor	Newcastle upon Tyne Hospitals NHS Trust (UK)
Funder	University of Newcastle upon Tyne (UK) - an own account trial

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A cluster randomised controlled trial of selective consent for the second trimester ultrasound scan
Study acronym	USS & You
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Maternal anxiety two weeks post scan as measured by the State Trait Anxiety Inventory (STAI) (Speilberger, 1983)
Key secondary outcome measure(s)	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
Completion date	20/11/2002
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1466
Key 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
Key exclusion criteria	1. Known twin pregnancy 2. Women who have been given a risk positive result from an earlier scan
Date of first enrolment	01/01/2002
Date of final enrolment	20/11/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Obstetrics and Gynaecology

Newcastle upon Tyne
NE1 7RU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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