Optimal Blood Pressure Treatment Thresholds Postpartum

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069102
• Other study ID #: STUDY23060147
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Eclampsia
• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy Induced
• Hypertension, Pregnancy-Induced
• Hypertensive Disorder of Pregnancy
• Pre-Eclampsia
• Pregnancy Complications
• Toxemia
• Vascular Diseases

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