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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06069102
Other study ID # STUDY23060147
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 15, 2023
Est. completion date December 1, 2025

Study information

Verified date February 2024
Source University of Pittsburgh
Contact Alisse K Hauspurg, MD
Phone 412-641-1381
Email janickia@upmc.edu
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States University of Pittsburgh Magee-Womens Hospital Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Alisse Hauspurg

Country where clinical trial is conducted

United States, 

Outcome

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