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
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 design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| 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 | Maternal anxiety two weeks post scan as measured by the State Trait Anxiety Inventory (STAI) (Speilberger, 1983) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2002 |
| 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 number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Obstetrics and Gynaecology
Newcastle upon Tyne
NE1 7RU
United Kingdom
NE1 7RU
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
"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 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
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
