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POP-HT trial (Physician Optimised Post-partum Hypertension Treatment)

A UK trial in women who had high blood pressure in pregnancy and still needed blood pressure medicine when they left hospital. Half used a home blood pressure monitor and a phone app, with doctors approving changes to their medicine; half had usual postnatal care. The women who self-monitored had lower blood pressure about 9 months after birth.

Also called POP-HT

  • Study
  • In this atlas

Overview

Design
Allocation: randomised. Intervention model: parallel. Masking: single (outcomes assessor, registry); the paper calls it open-label with a blinded end point. Primary purpose: prevention (registry values, paraphrased).
Phase
Not applicable
Enrolled
  • 200 participants (registry enrolment, type ESTIMATED) (planned count) (Physician Optimised Post-partum Hypertension Treatment Trial, retrieved )
  • 112 participants assigned to the intervention group (randomized count) (Long-Term Blood Pressure Control After Hypertensive Pregnancy Following Physician-Optimized Self-Management: The POP-HT Randomized Clinical Trial, retrieved )
  • 108 participants assigned to the control group (randomized count) (Long-Term Blood Pressure Control After Hypertensive Pregnancy Following Physician-Optimized Self-Management: The POP-HT Randomized Clinical Trial, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT04273854
Started
(actual) (Physician Optimised Post-partum Hypertension Treatment Trial, retrieved )
Primary completion
(anticipated) (Physician Optimised Post-partum Hypertension Treatment Trial, retrieved )
Completion
(anticipated) (Physician Optimised Post-partum Hypertension Treatment Trial, retrieved )
Countries
United Kingdom (Physician Optimised Post-partum Hypertension Treatment Trial, retrieved )
Care setting
A single hospital in the UK (the abstract). The registry lists two sites, both in Oxford. (Long-Term Blood Pressure Control After Hypertensive Pregnancy Following Physician-Optimized Self-Management: The POP-HT Randomized Clinical Trial, retrieved )
Registry status
  • “ACTIVE_NOT_RECRUITING” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Randomised, parallel-group trial (NCT04273854; phase not applicable). The paper (JAMA 2023, PMID 37950919) reports 220 randomised (112 intervention, 108 control) at a single UK hospital, with first enrolment on 21 February 2020 and last follow-up on 2 November 2021 (abstract); the primary outcome was the 24-hour mean diastolic pressure at 9 months after birth, adjusted for baseline. The registry (last update posted 2021-10-22) lists 200 as the estimated enrolment, ACTIVE_NOT_RECRUITING, estimated primary completion 2022-04-01 and estimated completion 2030-12-01, a primary outcome time frame of 6 months, and single masking of the outcomes assessor. The registry and the paper are not reconciled here. Registry lead sponsor: University of Oxford, with the British Heart Foundation as collaborator; neither is an organisation record in this atlas, so no sponsor link is made. Only the PubMed abstract was read.

Arms

  • Self-monitoring with physician-guided medicine changes

    Intervention Blood pressure self-monitoring and physician-guided dose changes after birth

    Women monitored their own blood pressure and followed a smartphone app algorithm that advised changes in medicine dose, overseen and approved by physicians (registry arm and intervention descriptions, paraphrased).

  • Usual postnatal care

    Intervention None named

    Usual NHS-led care, with the women's own health professionals assessing them and adjusting their medicine as needed; blood pressure was recorded at the same time points as in the intervention arm (registry arm description, paraphrased).

Findings

No findings are published for this study.

Record details

Record id
maternal:pop-ht-trial
Content hash
5ba764c98cf5d8a8e5ebb789e16151ea11344da8ce96bea06a2c98bed406616b