OPT-BP: Optimal Blood Pressure Treatment Thresholds Following a Hypertensive Disorder of Pregnancy: A Pilot Trial
概览
- 阶段
- 4 期
- 干预措施
- Usual care
- 疾病 / 适应症
- Hypertensive Disorder of Pregnancy
- 发起方
- Alisse Hauspurg
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Percent of participants eligible, enrolled and retained (feasibility)
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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.
研究者
Alisse Hauspurg
Assistant Professor
University of Pittsburgh
入排标准
入选标准
- •Postpartum individuals ≥18 years old
- •Preeclampsia or gestational hypertension diagnosis (complying ACOG criteria)
- •Enrolled in remote BP management program.
排除标准
- •Pre-pregnancy hypertension
- •Pre-pregnancy diabetes
- •Maternal cardiac disease
- •Chronic kidney disease
研究组 & 干预措施
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.
干预措施: Usual care
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.
干预措施: Tight blood pressure control
结局指标
主要结局
Percent of participants eligible, enrolled and retained (feasibility)
时间窗: Baseline to approximately 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.
次要结局
- Anti-hypertensive medication use(6 weeks postpartum)
- Change in diastolic BP(Enrollment to 6 weeks postpartum)
- Change in MAP(Enrollment to 6 weeks postpartum)
- Change in systolic BP(Enrollment to 6 weeks postpartum)
- Mean arterial pressure (efficacy)(6 months postpartum)
- Anti-hypertensive medication use (efficacy)(6 months postpartum)
- Diastolic blood pressure(6 weeks postpartum)
- Mean arterial pressure(6 weeks postpartum)
- Systolic blood pressure(6 months postpartum)
- Proportion of participants with readmissions(Enrollment through six months postpartum)
- Proportion of participants with ER visits(Enrollment through six months postpartum)
- Diastolic blood pressure(6 months postpartum)