Contact information
Type
Scientific
Primary contact
Prof Jenny Hewison
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HSR/037
Study information
Scientific title
Acronym
Study hypothesis
The 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
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
Screening
Patient information sheet
Condition
Pregnancy and hypertension
Intervention
1. Routine antenatal visits and clinic monitoring of blood pressure
2. A reduced number of antenatal visits and home monitoring of blood pressure.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Recruitment
2. Total number of clinic visits
3. Frequency of blood pressure measurements
4. Schedule preference
5. Anxiety
Secondary outcome measures
Not provided at time of registration
Overall trial start date
25/03/1996
Overall trial end date
24/09/1997
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant women
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80 (added 21/01/10; see publication)
Participant exclusion criteria
1. Multiple pregnancies
2. Established hypertension
3. Previous early-onset pre-eclampsia
4. Serious medical disease
5. Previous pregnancy loss after 24 weeks
Recruitment start date
25/03/1996
Recruitment end date
24/09/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Unit of Psychiatry and Behavioural Sciences
Leeds
LS2 9LT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
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
2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10688505
Publication citations
-
Results
Ross-McGill H, Hewison J, Hirst J, Dowswell T, Holt A, Brunskill P, Thornton JG, Antenatal home blood pressure monitoring: a pilot randomised controlled trial., BJOG, 2000, 107, 2, 217-221.