NCT04273854Active, not recruiting
Physician Optimised Post-partum Hypertension Treatment Trial
Source: ClinicalTrials.gov · Last updated 22 Oct 2021
Brief summary (registry, in English)
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 lower blood pressure after six months; even when medication has been stopped. The team now want to assess whether this blood pressure reduction can be reproduced in a larger, randomised, study (data analysis blinded) 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. The investigators 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. The investigators 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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 29 Jan 2020
- Start date
- 21 Feb 2020
- Primary completion date
- 1 Apr 2022
- Lead sponsor
- University of Oxford
- Diseases
- High blood pressure
- NCT number
- NCT04273854
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 21 Feb 2020 to the primary completion date, 1 Apr 2022
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled elective surgery (excluding caesarean sections) or other procedures requiring general anaesthesia during the trial.
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Other illness
- Significant renal or hepatic impairment that would affect safe medication titration and adjustment as part of the trial, as deemed by the Investigator.
- 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.
- 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:
Lab values
- eGFR \<30ml/minute.
Other
- Participant with life expectancy of less than 6 months.
- An absolute contra-indication to MRI (as per MRI safety questionnaire)
- Breast feeding,
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
Related publications
- Retinal Vascular Caliber: 6 to 12 Months and 15 to 25 Years Following Hypertensive Pregnancy.Hypertension · 2026 · PMID 42305089
- Brain Volumes After Hypertensive Pregnancy and Postpartum Blood Pressure Management: A POP-HT Randomized Clinical Trial Imaging Substudy.JAMA Neurol · 2026 · PMID 41490362
This page is information, not medical advice. Discuss any trial with your doctor.