Understanding Blood Pressure Changes After Birth
A Prospective Cohort Study, Understanding Blood Pressure Changes in the Immediate Twelve Weeks Postpartum for Women Who Had a Hypertensive Disorder in Pregnancy and How Existing Care Pathways Identify and Monitor Women at Risk of Cardiovascular Disease
1 other identifier
observational
300
1 country
1
Brief Summary
Research Question How does maternal blood pressure respond in the postpartum period for women who had a hypertensive disorder in pregnancy? Aim To evaluate the recovery of maternal blood pressure after a pregnancy affected by new onset hypertension after twenty weeks gestation Objectives
- To identify rates of persistent hypertension after pregnancies affected by HDP
- To assess and compare the accuracy of HBPM against the gold standard of ABPM
- To assess the maternal acceptance of HBPM and ABPM
- To explore what CVD-related care information is provided at the 6-8 week GP appointment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2021
CompletedFirst Posted
Study publicly available on registry
November 30, 2021
CompletedStudy Start
First participant enrolled
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 20, 2022
May 1, 2022
1.3 years
November 16, 2021
May 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of persistent hypertension in postpartum period
Blood Pressure expressed as mmHg at twelve weeks postpartum via 24 hour ambulatory blood pressure monitoring.
12 weeks
Secondary Outcomes (3)
Levels of agreement of diastolic and systolic blood pressures between HBPM and ABPM measurements
12 weeks
Identification of women who would benefit from closer BP surveillance
12 weeks
Key time points when BP should be monitored post birth
10 weeks
Eligibility Criteria
Participants will be selected via purposive sampling as participants will need to have a diagnosis of gestational hypertension and/or pre-eclampsia to participate in the study.
You may qualify if:
- Pregnant women with a confirmed diagnosis of new onset of high blood pressure after twenty weeks gestation
- Maternal Age \>16 years old
- Mental capacity to give informed consent
- Ability to be able to communicate to HCP if their BP range is above target (for example women where English is not their first language).
You may not qualify if:
- Pre-existing hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. George's University NHS Hopsitals
Wandsworth, London, SW17 0QT, United Kingdom
Related Publications (1)
Sheehan E, Wang C, Cauldwell M, Bick D, Thilaganathan B. Understanding maternal postnatal blood pressure changes following hypertensive disorders in pregnancy: protocol for a prospective cohort study. BMJ Open. 2022 Apr 1;12(4):e060087. doi: 10.1136/bmjopen-2021-060087.
PMID: 35365547DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2021
First Posted
November 30, 2021
Study Start
May 9, 2022
Primary Completion
August 31, 2023
Study Completion
December 31, 2023
Last Updated
May 20, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share