Home Blood Pressure Recording in Pregnancy - A Pilot Study for a Randomised Trial

ISRCTN ISRCTN20643323
DOI https://doi.org/10.1186/ISRCTN20643323
Secondary identifying numbers HSR/037
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
21/01/2010
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

Prof Jenny Hewison
Scientific

Academic Unit of Psychiatry and Behavioural Sciences
University of Leeds
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom

+44 (0)113 343 1894
j.hewison@leeds.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeScreening
Scientific title
Study objectivesThe traditional model of antenatal care often involves 14 or more clinical visits but there is large practice variation. The detection of hypertension is an important function of antenatal care and, unless blood pressure can be monitored outside the clinic, this sets a lower limit on the frequency of visits. We propose a pilot study (prior to embarking on a larger trial) where women would be randomised to receive EITHER routine antenatal visits and clinic monitoring of blood pressure OR a reduced number of antenatal visits and home monitoring of blood pressure. The pilot will investigate what proportion and types of women are willing to take part in such a study and whether women use portable blood pressure monitors satisfactorily and at the prescribed times. It will also be sufficient to measure major effects on anxiety and number of attendances.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy and hypertension
Intervention1. Routine antenatal visits and clinic monitoring of blood pressure
2. A reduced number of antenatal visits and home monitoring of blood pressure.
Intervention typeOther
Primary outcome measure1. Recruitment
2. Total number of clinic visits
3. Frequency of blood pressure measurements
4. Schedule preference
5. Anxiety
Secondary outcome measuresNot provided at time of registration
Overall study start date25/03/1996
Completion date24/09/1997

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants80 (added 21/01/10; see publication)
Key inclusion criteriaPregnant women
Key exclusion criteria1. Multiple pregnancies
2. Established hypertension
3. Previous early-onset pre-eclampsia
4. Serious medical disease
5. Previous pregnancy loss after 24 weeks
Date of first enrolment25/03/1996
Date of final enrolment24/09/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Unit of Psychiatry and Behavioural Sciences
Leeds
LS2 9LT
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2000 Yes No
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