Physician Optimised Post-partum Hypertension Treatment Trial (POP-HT)
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ClinicalTrials.gov Identifier: NCT04273854 |
Recruitment Status :
Active, not recruiting
First Posted : February 18, 2020
Last Update Posted : October 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Pre-Eclampsia Gestational Hypertension | Device: OMRON Evolv® blood pressure monitor (Blue-tooth® enabled) & Proprietary Smartphone POP-HT app® | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | All downstream data analysis will be done by investigators blinded to the allocation |
Primary Purpose: | Prevention |
Official Title: | Physician Optimised Post-partum Hypertension Treatment Trial |
Actual Study Start Date : | February 21, 2020 |
Estimated Primary Completion Date : | April 1, 2022 |
Estimated Study Completion Date : | December 1, 2030 |
Arm | Intervention/treatment |
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Experimental: Intervention
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.
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Device: OMRON Evolv® blood pressure monitor (Blue-tooth® enabled) & Proprietary Smartphone POP-HT app®
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. This is overseen and any change is approved by physicians who can review the uploaded readings and respond to tele-monitored abnormal readings in a timely fashion. |
No Intervention: Control
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.
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- Diastolic Blood pressure (BP) [ Time Frame: 6 months post-partum ]24 hour average diastolic BP measured by 24 hour ambulatory BP monitoring (ABPM)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Must be female anatomy and genetically and have conceived and given birth |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273854
United Kingdom | |
Oxford University Hospitals NHS Foundation Trust | |
Oxford, Oxfordhsire, United Kingdom, OX3 9DU | |
Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford | |
Oxford, Oxfordshire, United Kingdom, OX3 9DU |
Responsible Party: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT04273854 |
Other Study ID Numbers: |
273353 FS/19/7/34148 ( Other Grant/Funding Number: Funder: British Heart Foundation ) |
First Posted: | February 18, 2020 Key Record Dates |
Last Update Posted: | October 22, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Data will be made available, under certain circumstances, following data lock upon request to the study PI. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Eclampsia Pre-Eclampsia Hypertension, Pregnancy-Induced Hypertension Vascular Diseases |
Cardiovascular Diseases Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |