Physician Optimised Post-partum Hypertension Treatment Trial (POP-HT)
Pre-Eclampsia, Gestational Hypertension
About this trial
This is an interventional prevention trial for Pre-Eclampsia
Eligibility Criteria
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the trial.
- Female, aged 18 years or above.
- Clinician confirmed diagnosis of either gestational hypertension or pre-eclampsia defined by NICE NG 133
- Requiring anti-hypertensive medication at the point of discharge from secondary care.
- Participant has clinically acceptable laboratory results and clinical course post-partum with no other adverse complicating factor requiring prolonged admission post-partum that would make participation unfeasible as judged by the CI. Examples would include stroke sequalae, ongoing DIC, the baby/babies requiring prolonged NICU/SCBU admission of >1 week.
- In the Investigator's opinion, is able and willing to comply with all trial requirements including ownership of a 'Smart-phone/Tablet' and willing to use the smart-phone app if randomised to that arm.
- Sufficient competence in English Language to follow the app instructions and partake in the study, as judged by the CI
Exclusion Criteria:
- Significant renal or hepatic impairment that would affect safe medication titration and adjustment as part of the trial, as deemed by the Investigator.
- Scheduled elective surgery (excluding caesarean sections) or other procedures requiring general anaesthesia during the trial.
- Participant with life expectancy of less than 6 months.
- Any other significant disease or disorder, which, in the opinion of the Investigator, may either, put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- An absolute contra-indication to MRI (as per MRI safety questionnaire)
- Women with pre-existing hypertension will be excluded, as this is a separate pathology that would affect the efficacy of the study intervention and affect the primary and secondary outcomes of the study.
Additional exclusion criteria specific to the Gadolinium sub-study are:
- Breast feeding,
- eGFR <30ml/minute.
Sites / Locations
- Oxford University Hospitals NHS Foundation Trust
- Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention
Control
The intervention will consist of physician-optimised self-management of post-partum BP. Women will follow a 'smartphone' app based algorithm for medication-titration, which will provide individualised dose titration advice.
The control arm will be managed as per usual NHS led care with assessment by their own health care professionals and adjustment of their medications as is needed. The BP of this group will be monitored and recorded at the same time-points and in the same manner as the intervention arm as will all other secondary outcome measures.