Monitoring of hypertension in women following hypertensive pregnancy Circulatory System
Conditions
Interventions
Women recruited to the study will be randomly assigned to one of two groups: either monitoring their own blood pressure and using this to manage their blood pressure medication, or receiving the stand
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. People who have recently given birth within the last 7 days 3. Aged 18 years or above 4. Participant with pregnancy hypertension including: chronic/essential hypertension (predating current pregnancy or requiring treatment before 20/40), or gestational hypertension (new-onset hypertension from 20/40 of index pregnancy) or pre-eclampsia (hypertension (GH or with proteinuria or metabolic changes), prior to their discharge from hospital post-delivery. 5. Participant still requiring antihypertensive medication at randomisation following delivery 6. Able and willing to comply with trial requirements 7. Willing to allow their primary and secondary healthcare teams, if appropriate, to be notified of participation in the trial 8. Access to a smartphone compatible with the app
Exclusion criteria
Exclusion criteria: 1. Participant does not wish to self-monitor/self-manage their blood pressure 2. Participant already taking part in another trial that might affect their anti-hypertensive prescription
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 22/10/2025: Mean daytime ambulatory diastolic blood pressure measured using an ambulatory blood pressure monitor at 26-39 weeks. _____ Previous primary outcome measures: Mean daytime ambulatory diastolic blood pressure measured using an ambulatory blood pressure monitor at 26 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/10/2025: 1. Mean daytime ambulatory systolic blood pressure measured using an ambulatory blood pressure monitor at 26-39 weeks 2. Mean 24-hour and nocturnal ambulatory blood pressure measured using an ambulatory blood pressure monitor at 26-39 weeks 3. Systolic and diastolic blood pressure at follow-up (mean of 2nd/3rd readings and mean of 2nd – 6th readings) measured in clinic or at home at baseline, 6 weeks, 12 weeks, 26-39 weeks and 48-60 weeks 4. Maternal health-related quality of life measured using EQ-5D-5L health questionnaire results at baseline, 6 weeks, 12 weeks, 26-39 weeks and 48-60 weeks 5. Anxiety associated with self-management of BP measured using the short-form anxiety inventory questionnaire at baseline, 12 weeks and 48-60 weeks 6. Medication adherence measured by the presence of urinary antihypertensive metabolites at 6 weeks and the Medication Adherence Rating Scale (MARS) at baseline and 6 weeks 7. Postnatal readmissions measured using all-cause admissions, pregnancy hypertension admissions and cardiovascular events at records review 8. Healthcare resource use and cost analysis of key cost drivers between study arms measured using participant resource use data collection at baseline, 12 weeks, 26-39 weeks and 48-60 weeks 9. Cost-consequence analysis presenting costs and key outcomes in a disaggregated manner measured over the trial period 10. Long-term modelled cost-utility analysis using quality-adjusted life years (QALYs) measured using Modelled lifetime horizon and Sensitivity analysis to judge time to benefit/harm 11. Qualitative process evaluation measured using in-depth semi-structured interviews over the trial period _____ Previous secondary outcome measures: 1. Mean daytime ambulatory systolic blood pressure measured using an ambulatory blood pressure monitor at 26 weeks 2. Mean 24-hour and nocturnal ambulatory blood pressure measured using an ambulatory blood pressure monitor at 26 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactRIchard McManus
Outcome results
None listed