Status:
ACTIVE_NOT_RECRUITING
Physician Optimised Post-partum Hypertension Treatment Trial
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
British Heart Foundation
Conditions:
Pre-Eclampsia
Gestational Hypertension
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
It has been shown in a pilot randomised controlled study \[SNAP-HT \[4\]; REC 14/SC/1316\] that blood pressure self-management during the post-partum period after hypertensive pregnancies, results in ...
Detailed Description
Summary of the Design ---------------------- The trial is a single centre, single blinded (the investigators will be unaware of which group the participants are allocated to), and randomised controlle...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04273854
Start Date
February 21 2020
End Date
December 1 2030
Last Update
October 22 2021
Active Locations (2)
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1
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordhsire, United Kingdom, OX3 9DU
2
Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 9DU