Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/01/2010
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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes