SNAP-HT trial development pilot study V1.0
Research type
Research Study
Full title
Self-maNAgement of Postnatal anti-Hypertensive Treatment: SNAP-HT trial development pilot study
IRAS ID
159884
Contact name
Alexandra E Cairns
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
New-onset raised blood pressure (BP) affects about one in ten pregnancies. For some women, raised BP is an indication of pre-eclampsia: newly arising high blood pressure in pregnancy combined with protein leaking into the urine. After birth, women’s BP remains elevated for a period of time, but in most cases returns to normal over 2–12 weeks. During this period medication needs to be adjusted to achieve the correct control. Research suggests that better BP control during this period is associated with improved long-term health outcomes. We would like to find out whether home BP monitoring, and self-adjustment of medications according to an individualised protocol, could improve BP control and patient satisfaction.
This pilot study has been set up to inform the planning of a large-scale multi-centre randomised controlled trial by testing the feasibility of the protocol. We want to increase our experience of applying this management approach in this subset of patients; to select the most appropriate primary outcome measure and to estimate the effect size of this intervention; to assess recruitment potential; and to evaluate feasibility of coordinating this trial across several centres. The primary objective of the large-scale trial will be to determine whether the self-management approach can improve BP control in women with medicated hypertensive disorders of pregnancy in the postnatal period.
Women recruited to the study will be randomly assigned to one of two groups: self-management or usual care. Participants allocated to ‘usual care’ will have their BP monitored and medication adjusted by their GP and midwife as normal. Participants allocated to the ‘self-management’ group will use a home BP monitor daily following discharge from hospital after birth. They will be provided with an individualised schedule for gradually decreasing their medication(s) in line with their BP readings. Women will be followed up for 6 months.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/1316
Date of REC Opinion
19 Nov 2014
REC opinion
Further Information Favourable Opinion