Contact information
Type
Scientific
Primary contact
Prof Stephen Robson
ORCID ID
Contact details
Royal Victoria Infirmary
Dept of Obstetrics & Gynaecology 4th Floor
Leazes Wing
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 282 4132
s.c.robson@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC138R R6003
Study information
Scientific title
A randomised trial of early ultrasound screening for fetal abnormality
Acronym
Study hypothesis
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
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
Pregnancy and childbirth: Pregnancy
Intervention
1. Early ultrasound screening for structural and chromosomal abnormalities
2. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
10/01/2000
Overall trial end date
10/01/2003
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
15000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
10/01/2000
Recruitment end date
10/01/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Not defined
Funder name
NHS Executive Northern and Yorkshire (UK)
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