Condition category
Pregnancy and Childbirth
Date applied
09/09/2005
Date assigned
23/11/2005
Last edited
05/11/2014
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

Ms Vikki Snaith

ORCID ID

Contact details

Research Midwives Office
4th Floor
Leazes Wing
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 2820540

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 measures

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

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24685072

Publication citations

  1. 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.

Additional files

Editorial Notes