Clinical trial NCT06069102: Optimal Blood Pressure Treatment Thresholds Postpartum
Official title: OPT-BP: Optimal Blood Pressure Treatment Thresholds Following a Hypertensive Disorder of Pregnancy: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hypertensive Disorder of Pregnancy
Pre-Eclampsia
Hypertension
Eclampsia
Gestational Hypertension
Cardiovascular Diseases
Toxemia
Pregnancy Complications
Vascular Diseases
Hypertension, Pregnancy Induced
Hypertension;Pre-Eclamptic
Keywords: Hypertension
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a prospective single site, single-blinded, parallel randomized control trial in which individuals diagnosed with HDP will be randomized to usual care or tight blood pressure control for therapeutic intent. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of participants eligible, enrolled and retained (feasibility)
timeFrame: Baseline to approximately 6 months postpartum
Secondary outcomes:
measure: Anti-hypertensive medication use (efficacy)
timeFrame: 6 months postpartum
measure: Anti-hypertensive medication use
timeFrame: 6 weeks postpartum
measure: Mean arterial pressure (efficacy)
timeFrame: 6 months postpartum
measure: Mean arterial pressure
timeFrame: 6 weeks postpartum
measure: Systolic blood pressure
timeFrame: 6 months postpartum
measure: Diastolic blood pressure
timeFrame: 6 months postpartum
measure: Diastolic blood pressure
timeFrame: 6 weeks postpartum
measure: Change in MAP
timeFrame: Enrollment to 6 weeks postpartum
measure: Change in systolic BP
timeFrame: Enrollment to 6 weeks postpartum
measure: Change in diastolic BP
timeFrame: Enrollment to 6 weeks postpartum
measure: Proportion of participants with readmissions
timeFrame: Enrollment through six months postpartum
measure: Proportion of participants with ER visits
timeFrame: Enrollment through six months postpartum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: UPMC Magee Women's Hospital
name: Alisse K Hauspurg, MD
role: PRINCIPAL_INVESTIGATOR
References: