POP-HT Trial
Research type
Research Study
Full title
Physician Optimised Post-partum Hypertension Treatment (POP-HT) trial
IRAS ID
273353
Contact name
Paul Leeson
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
11 years, 0 months, 0 days
Research summary
We have shown in a pilot randomised controlled study [SNAP-HT; REC 14/SC/1316] that blood pressure self-management during the post-partum period after hypertensive pregnancies, results in lower blood pressure after six months; even when medication has been stopped. We now want to assess whether this blood pressure reduction can be reproduced in a larger, randomised, single-blinded study and whether the blood pressure lowering has additional benefits in terms of other cardiovascular and cerebrovascular changes known to occur in women who have had a hypertensive pregnancy. We therefore plan to run a trial of self-management in the post-partum period, using updated Blue-tooth® enabled blood pressure monitoring coupled to physician-assisted dose titration to further advance the self-management aspect of the intervention. The physicians will be specialist clinicians who form part of the research team. We will measure additional structural and functional end organ differences, using magnetic resonance imaging of the brain and heart as well as echocardiography and retinal imaging. This will provide insight into the impact of post-partum blood pressure control on the maternal cardiovascular system and how this associates with blood pressure changes. Together, these studies will help refine future intervention strategies in this cohort of patients.
We have consulted the MHRA (MHRA Ref: E/2019/0717) regarding the planned use of 'app' based tele-monitoring and they are satisfied the app is not classed as a medical device (see appendix for e-mail correspondence between MHRA and the research team) and that normal REC and HRA approval should be sought.
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/1901
Date of REC Opinion
17 Dec 2019
REC opinion
Favourable Opinion