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Completed

NCT Number: NCT06069102

Optimal Blood Pressure Treatment Thresholds Postpartum

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Drug

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

Drug

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

Primary outcomes

  1. Percent of Participants Eligible, Enrolled and Retained (Feasibility)

    Time frame: Baseline to approximately 6 months postpartum, a total of 6 months postpartum

    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.

Secondary outcomes

  1. Number of Participants With Anti-hypertensive Medication Use

    Time frame: 6 months postpartum

    Number of participants with anti-hypertensive medication use

  2. Anti-hypertensive Medication Use

    Time frame: 6 weeks postpartum

    Anti-hypertensive medication use

  3. Mean Arterial Pressure (Efficacy)

    Time frame: 6 months postpartum

    Mean arterial pressure (systolic BP + 2*diastolic BP / 3)

  4. Mean Arterial Pressure

    Time frame: 6 weeks postpartum

    Mean arterial pressure (systolic BP + 2*diastolic BP / 3)

  5. Systolic Blood Pressure

    Time frame: 6 months postpartum

    Mean systolic blood pressure

  6. Diastolic Blood Pressure

    Time frame: 6 months postpartum

    Mean diastolic blood pressure

  7. Diastolic Blood Pressure

    Time frame: 6 weeks postpartum

    Mean diastolic blood pressure

  8. Change in MAP

    Time frame: 6 weeks postpartum

    Change in mean arterial pressure (systolic BP + 2*diastolic BP / 3) from baseline

  9. Change in Systolic BP

    Time frame: 6 weeks postpartum

    Change in systolic BP from baseline

  10. Change in Diastolic BP

    Time frame: 6 weeks postpartum

    Change in diastolic BP from baseline

  11. Number of Participants With Hospital Readmissions

    Time frame: Six months postpartum

    Postpartum hospital readmissions

  12. Number of Participants With ER Visits

    Time frame: Six months postpartum

    Emergency room visits

Other outcomes

  1. Interval Participant Retention

    Time frame: 6 weeks postpartum

    Number of participants retained to 6 weeks postpartum

  2. Participant Retention

    Time frame: 6 months postpartum

    Retention of participants to 6 months postpartum

Sponsors and collaborators

Lead sponsor

Alisse Hauspurg

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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