Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N&AHP/04/001
Study information
Scientific title
Acronym
SRAC
Study hypothesis
The project aims to evaluate the effects of two packages of care that may provide women with greater support and reassurance during the third trimester of pregnancy without increasing the number of antenatal contacts that they receive.
Hypothesis: A structured telephone support intervention (with or without supplemental uterine artery Doppler screening) encourages women to adhere to the antenatal visit schedule proposed by the National Institute of Clinical Excellence (2003).
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
Other
Trial type
Other
Patient information sheet
Condition
Antenatal care
Intervention
Randomised controlled trial of a structured telephone support intervention provided by a midwife +/- uterine artery Doppler screening.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number of antenatal contacts with health professionals.
Secondary outcome measures
1. Number of antenatal admissions to hospital
2. Anxiety
3. Levels of perceived social support
4. Satisfaction with care
5. Economic evaluation
6. Major clinical outcomes
Overall trial start date
01/02/2004
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Low risk primiparous women booked for delivery at the Royal Victoria Infirmary, Newcastle upon Tyne
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
764
Participant exclusion criteria
Women who are unable to understand English
Recruitment start date
01/02/2004
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Research Midwives Office
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Trust (UK)
Sponsor details
Research and Development
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE2 4LP
United Kingdom
craig.mackerness@nuth.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Co-ordinating Centre for Research Capacity Building (UK) - Nursing and Allied Health Professions Award (ref: N&AHP/04/001)
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24685072
Publication citations
-
Results
Snaith VJ, Hewison J, Steen IN, Robson SC, Antenatal telephone support intervention with and without uterine artery Doppler screening for low risk nulliparous women: a randomised controlled trial., BMC Pregnancy Childbirth, 2014, 14, 121, doi: 10.1186/1471-2393-14-121.