Optimal Blood Pressure Treatment Thresholds Postpartum

Status Recruiting

Clinical Trial Summary

The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP). The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

Clinical Trial Description

The investigators will determine the feasibility of conducting a randomized controlled trial of tight blood pressure control (<135/85 mmHg on home BP monitoring) vs. standard of care (<150/100 mmHg on home BP monitoring) in postpartum individuals following a HDP with assessment of individuals who are eligible, enrolled, and remain in the study until six weeks postpartum. Individuals who are retained in the study for 6 months postpartum. Lastly, investigators will analyze effect outcomes to inform the sample size for a subsequent large-scale randomized trial. This will be done through analysis of mean arterial pressure (MAP), systolic blood pressure, and diastolic blood pressure of participants at 6 weeks and at 6 months postpartum. The study will be conducted on the postpartum unit of Magee-Womens Hospital. Participants will be enrolled at the time of postpartum hospitalization with study visit #1 occurring in the hospital. At this study visit, participants will be administered questionnaires, will provide a blood sample, and BP will be measured. Study visit #2 will be a remote study visit conducted via telemedicine or a telephone call at 6 weeks postpartum. At this visit, participants will provide questionnaires and blood pressure data. Study visit #3 will be a remote study visit conducted via telemedicine or a telephone call at 6 months postpartum. At this visit, participants will again provide questionnaires and blood pressure data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06069102
Study type	Interventional
Source	University of Pittsburgh
Contact	Alisse K Hauspurg, MD
Phone	412-641-1381
Email	janickia@upmc.edu
Status	Recruiting
Phase	Phase 4
Start date	November 15, 2023
Completion date	December 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04591808` - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia	Phase 3
Recruiting	`NCT04515303` - Digital Intervention Participation in DASH
Completed	`NCT05433233` - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension	N/A
Completed	`NCT05491642` - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses	Phase 1
Completed	`NCT03093532` - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT05529147` - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting	`NCT06363097` - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Recruiting	`NCT05976230` - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed	`NCT06008015` - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers	Phase 1
Completed	`NCT05387174` - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period	N/A
Completed	`NCT04082585` - Total Health Improvement Program Research Project
Recruiting	`NCT05121337` - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension	N/A
Withdrawn	`NCT04922424` - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men	Phase 1
Active, not recruiting	`NCT05062161` - Sleep Duration and Blood Pressure During Sleep	N/A
Completed	`NCT05087290` - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting	`NCT05038774` - Educational Intervention for Hypertension Management	N/A
Completed	`NCT05621694` - Exploring Oxytocin Response to Meditative Movement	N/A
Completed	`NCT05688917` - Green Coffee Effect on Metabolic Syndrome	N/A
Recruiting	`NCT05575453` - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure	N/A