Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/02/2016
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 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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

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