Optimal Blood Pressure Treatment Thresholds Postpartum

OPT-BP: Optimal Blood Pressure Treatment Thresholds Following a Hypertensive Disorder of Pregnancy: A Pilot Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Toxemia; Hypertension; Pregnancy Complications; Eclampsia; Pre-Eclampsia; Hypertensive Disorder of Pregnancy; Gestational Hypertension; Hypertension, Pregnancy Induced; Hypertension;Pre-Eclamptic
• Intervention / Treatment: Drug: Usual care; Drug: Tight blood pressure control

Detailed 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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alisse K Hauspurg, MD; Phone Number: 412-641-1381; Email: janickia@upmc.edu
• Study Contact Backup: Name: Sila Yavan, MS; Phone Number: 4122280595; Email: yavans@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Magee-Womens Hospital
      • Contact: Sila Yavan; Phone Number: 412-641-3295; Email: yavans@upmc.edu
      • Contact: Alisse Hauspurg, MD; Phone Number: 412-641-2291; Email: janickia@upmc.edu
      • Principal Investigator: Alisse Hauspurg, MD
      • Sub-Investigator: Hyagriv Simhan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Postpartum individuals ≥18 years old
• Preeclampsia or gestational hypertension diagnosis (complying ACOG criteria)
• Enrolled in remote BP management program.

Exclusion Criteria:

• Pre-pregnancy hypertension
• Pre-pregnancy diabetes
• Maternal cardiac disease
• Chronic kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care Group; Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.	Drug: Usual care; The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.
Experimental: Intervention (Tight Blood Pressure Control) Group; BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg.	Drug: Tight blood pressure control; The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.; Other Names: Tight control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants eligible, enrolled and retained (feasibility)	To determine if a randomized controlled trial of tight blood pressure control (<135/85 mmHg on home blood pressure monitoring) vs. standard of care (<150/100 mmHg on home blood pressure monitoring) in postpartum individuals following a hypertensive disorder of pregnancy (HDP) is feasible.	Baseline to approximately 6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-hypertensive medication use (efficacy)	Anti-hypertensive medication use	6 months postpartum
Anti-hypertensive medication use	Anti-hypertensive medication use	6 weeks postpartum
Mean arterial pressure (efficacy)	Mean arterial pressure (systolic BP + 2*diastolic BP / 3)	6 months postpartum
Mean arterial pressure	Mean arterial pressure (systolic BP + 2*diastolic BP / 3)	6 weeks postpartum
Systolic blood pressure	Mean systolic blood pressure	6 months postpartum
Diastolic blood pressure	Mean diastolic blood pressure	6 months postpartum
Diastolic blood pressure	Mean diastolic blood pressure	6 weeks postpartum
Change in MAP	Change in mean arterial pressure (systolic BP + 2*diastolic BP / 3)	Enrollment to 6 weeks postpartum
Change in systolic BP	Change in systolic BP	Enrollment to 6 weeks postpartum
Change in diastolic BP	Change in diastolic BP	Enrollment to 6 weeks postpartum
Proportion of participants with readmissions	Postpartum hospital readmissions	Enrollment through six months postpartum
Proportion of participants with ER visits	Emergency room visits	Enrollment through six months postpartum

Collaborators and Investigators

• Sponsor: Alisse Hauspurg
• Investigators: Principal Investigator: Alisse K Hauspurg, MD, UPMC Magee Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension
• Additional Relevant MeSH Terms: Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Toxemia; Hypertension; Cardiovascular Diseases; Vascular Diseases; Eclampsia; Pre-Eclampsia; Pregnancy Complications; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: STUDY23060147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data (including data dictionaries) will be shared at the direction of the primary investigator. Data will include blood pressure, weight, demographics, physical activity, and pregnancy related information. Additional documents (such as the study protocol) will be made available. The dataset for our project will be prepared according to requirements for and stored on the Clinicaltrials.gov data repository. Per the NIH guidelines, the dataset will be submitted to the program officer within a year after the outcomes are published and no later than 3 years after the end of clinical activities.
• IPD Sharing Time Frame: Within a year after outcomes are published and no later than 3 years after the end of clinical activities.
• IPD Sharing Access Criteria: NHLBI data repository request process
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No