ISRCTN ISRCTN62354584
DOI https://doi.org/10.1186/ISRCTN62354584
Protocol serial number N&AHP/04/001
Sponsor Newcastle upon Tyne Hospitals NHS Trust (UK)
Funder National Co-ordinating Centre for Research Capacity Building (UK) - Nursing and Allied Health Professions Award (ref: N&AHP/04/001)
Submission date
09/09/2005
Registration date
23/11/2005
Last edited
05/11/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Vikki Snaith
Scientific

Research Midwives Office
4th Floor, Leazes Wing
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom

Phone +44 (0)191 2820540

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymSRAC
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAntenatal care
InterventionRandomised controlled trial of a structured telephone support intervention provided by a midwife +/- uterine artery Doppler screening.
Intervention typeOther
Primary outcome measure(s)

Number of antenatal contacts with health professionals.

Key secondary outcome measure(s)

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

Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration764
Key inclusion criteriaLow risk primiparous women booked for delivery at the Royal Victoria Infirmary, Newcastle upon Tyne
Key exclusion criteriaWomen who are unable to understand English
Date of first enrolment01/02/2004
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Research Midwives Office
Newcastle upon Tyne
NE1 4LP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 31/03/2014 Yes No