A randomised trial of early ultrasound screening for fetal abnormality

ISRCTN	ISRCTN37543746
DOI	https://doi.org/10.1186/ISRCTN37543746
Secondary identifying numbers	RRCC138R R6003

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 09/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
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 Stephen Robson
Scientific

Royal Victoria Infirmary
Dept of Obstetrics & Gynaecology 4th Floor
Leazes Wing
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Phone	+44 (0)191 282 4132
Email	s.c.robson@ncl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised trial of early ultrasound screening for fetal abnormality
Study objectives	This is a randomised trial to evaluate the effects on pregnancy management and outcome of adding early ultrasound screening for structural and chromosomal abnormalities to an existing antenatal screening programme (maternal serum screening at 16 weeks and ultrasound screening at 18-20 weeks). The general hypothesis is that early ultrasound screening will improve maternal psychological outcome following termination of pregnancy (TOP) for fetal abnormality. The specific hypotheses to be tested are; Primary Addition of early ultrasound screening reduces grief, depression and distress after TOP for fetal abnormality. Secondary Addition of early ultrasound screening 1. Does not increase maternal anxiety in those receiving false positive results, while in those receiving screen negative results it 2. Provides reassurance 3. Has beneficial effects on attitudes to the fetus and 4. Has beneficial effects on smoking. The cost-effectiveness of introducing early ultrasound screening will also be examined.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and childbirth: Pregnancy
Intervention	1. Early ultrasound screening for structural and chromosomal abnormalities 2. Standard care
Intervention type	Other
Primary outcome measure	1. In women undergoing TOP 1.1. Grief (Perinatal Grief scale) 1.2. Depression (HAD-D scale) 1.3. Distress (Impact of Events scale) 2. In women receiving screen positive results (ultrasound or serum screening): 2.1. Anxiety (HAD-A scale and State-Trait Anxiety scale) 3. In women receiving screen negative results: 3.1. Anxiety (HAD-A scale) 3.2. Maternal-Fetal Attachment Scale 3.3. Smoking status 4. Costs (patient and NHS) and cost utilities 5. Prevalence of congenital abnormalities (detected up to one month of age) 6. Total and late TOP for fetal abnormality 7. Perinatal mortality
Secondary outcome measures	Not provided at time of registration
Overall study start date	10/01/2000
Completion date	10/01/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	15000
Key inclusion criteria	15000 women (7500 in each arm) - estimate ~50 women undergoing TOP in each arm. 225 women with false positive results and 225 screen negative women.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	10/01/2000
Date of final enrolment	10/01/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Victoria Infirmary

Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Not defined

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

09/03/2018: No publications found, verifying study status with principal investigator.
29/02/2016: No publications found, verifying study status with principal investigator.