OPTIMUM-BP (version 1.0)
Research type
Research Study
Full title
Blood pressure self-monitoring for the management of women during pregnancy with chronic hypertension: a feasibility study
IRAS ID
186161
Contact name
Louise Pealing
Contact email
Sponsor organisation
University of Oxford Clinical Trials and Research Governance Team (CTRG)
Duration of Study in the UK
2 years, 3 months, 28 days
Research summary
Chronic hypertension usually requires treatment during pregnancy and is a strong risk factor for pre-eclampsia. NICE guidelines recommend more frequent antenatal visits for these women. Despite more frequent monitoring these women can still have poor blood pressure control and can develop pre-eclampsia between antenatal visits.
Self-monitoring of blood pressure in pregnancy complicated by chronic hypertension could improve the detection and management of hypertension in pregnancy by providing much closer surveillance without appreciably increasing the burden on women. Clinicians will be able to make more informed treatment decisions taking into account home and clinic blood pressure readings and women may feel more empowered and involved in their care.
This randomised controlled feasibility study will collect data to inform the design of a future large trial and will also provide qualitative information around the acceptability and feasibility of self-monitoring for this group.
This study will recruit pregnant women with chronic hypertension from antenatal clinic. Women will be randomised to either usual care or additional blood pressure self-monitoring. Participants in the intervention arm will be asked to measure their blood pressure twice in the morning every day throughout pregnancy and to record these readings. The home blood pressure readings will be available in addition to clinic readings for clinicians making treatment decisions during the antenatal period.
All women in the study will continue to receive usual antenatal care. Women obtaining any raised or low home blood pressure readings will be advised how to contact their clinical teams. Home and clinic blood pressure readings and information on medication changes, admissions to hospital, any diagnosis of pre-eclampsia and birth weights will be collected at extended antenatal visits and after delivery. In addition, women and clinicians will be interviewed about their experience of using blood pressure self-monitoring to help identify any facilitators or barriers for the intervention.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0490
Date of REC Opinion
28 Oct 2015
REC opinion
Further Information Favourable Opinion