跳至主要内容
临床试验/NCT05849103
NCT05849103已完成不适用

Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 343 人开始时间: 2023年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
343
试验地点
1
主要终点
Proportion of Participants With Recorded Blood Pressure Values in Office

研究概览

简要总结

Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.

详细描述

Hypertension complicates 10% of pregnancies in the U.S., directly accounting for 7% of pregnancy-related deaths and 38% of severe maternal morbidity. Hypertensive disorders of pregnancy (HDP) include chronic hypertension, gestational hypertension, preeclampsia, hemolysis-elevated-liver enzymes-low platelets (HELLP), and eclampsia, and occur 2.5 times more frequently among Black compared to non-Black patients. The weeks after delivery are crucial for maternal health, severe maternal morbidity, and hypertension-associated morbidity. Half of all pregnancy-related deaths occur in this time and Black patients are impacted disproportionally by these morbidities including pulmonary edema, stroke, and renal failure.

The American College of Obstetricians and Gynecologists (ACOG) recently redefined postpartum care to encompass 12 months after birth and stressed the importance of connecting postpartum patients to primary care clinicians to manage chronic conditions. This handoff is critical as 50% of patients with HDP develop chronic hypertension, and patients affected by HDP have twice the risk of later cardiovascular-related death. Recently, Tennessee expanded Medicaid coverage to 12 months postpartum. Given that most obstetric clinicians do not provide comprehensive primary care, investigators urgently need models for bridging gaps in care after pregnancy. While interventions such as telemedicine and peer navigation demonstrate promise to improve patient engagement in care and reduce postpartum racial disparities,15-18 no randomized trials address system-level initiatives to improve postpartum care for patients with HDP.

Another area of active investigation relates to establishing appropriate blood pressure targets for patients in and around the time of pregnancy. Recent findings from the Chronic Hypertension and Pregnancy Trial suggest that stricter control of antepartum blood pressure is beneficial in reducing the incidence of a composite adverse perinatal outcome which included preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks of gestation, placental abruption, and fetal or neonatal death. This trial has been practice-changing, lowering the historic antepartum blood pressure target from 160/110mmHg (millimeter of mercury) to less than 140/90mmHg. However, this trial did not contemplate the management of maternal blood pressure in the postpartum period. ACOG presently endorses a postpartum goal of less than 150/100mmHg which, notably, is higher than the newly established antepartum goal. Furthermore, the blood pressure target set for non-pregnant adults by the American College of Cardiology and American Heart Association is even lower, at less than 120/80mmHg to minimize the cardiovascular disease risk associated with chronic hypertension.

Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Research personnel assessing outcomes will be masked to the intervention

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age >18 years
  • Diagnosed with a Hypertensive Disorder of Pregnancy (HDP), which includes chronic hypertension, preeclampsia, gestational hypertension, HELLP Syndrome (Hemolysis, Elevated Liver enzymes, Low Platelets), or eclampsia (O10, O11, O13, O14, O15, O16)

排除标准

  • 1. Not able or willing to receive electronic surveys
  • Deemed inappropriate for study enrollment by the bedside nurse
  • Non-English speaking
  • Contraindication to ACOG-recommended hypertension control (i.e. chronic kidney disease, stroke)

研究组 & 干预措施

A) Standard BP Control, Clinician Monitoring

Active Comparator

Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.

干预措施: Blood Pressure Control Targets (Other)

A) Standard BP Control, Clinician Monitoring

Active Comparator

Target blood pressure will be less than 150/100. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.

干预措施: Hypertension Management (Other)

B) Tight BP Control, Clinician Monitoring

Active Comparator

Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.

干预措施: Blood Pressure Control Targets (Other)

B) Tight BP Control, Clinician Monitoring

Active Comparator

Target blood pressure will be less than 140/90. Participants will be instructed to check their blood pressures twice a day for two weeks and daily for weeks 3-6 after delivery and report abnormal blood pressures or symptoms to their obstetric clinicians. Additional postpartum visits beyond the blood pressure check will be directed by their obstetric clinician.

干预措施: Hypertension Management (Other)

C) Standard BP Control, Care Navigation

Active Comparator

Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.

干预措施: Blood Pressure Control Targets (Other)

C) Standard BP Control, Care Navigation

Active Comparator

Target blood pressure will be less than 150/100. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.

干预措施: Hypertension Management (Other)

D) Tight BP Control, Care Navigation

Active Comparator

Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.

干预措施: Blood Pressure Control Targets (Other)

D) Tight BP Control, Care Navigation

Active Comparator

Target blood pressure will be less than 140/90. Participants will check blood pressures twice daily for 14 days and daily for weeks 3-6. A nurse navigator will review their blood pressures M-F for Weeks 1-2 and weekly for weeks 3-6 and will provide feedback on blood pressure values and recommend initiating or escalating medications as needed. The nurse navigator will communicate progress to the participant's clinicians and will remind the participant of their appointments. The nurse navigator will facilitate a visit around 3 months with a primary care clinician or a cardiologist for hypertension follow up.

干预措施: Hypertension Management (Other)

结局指标

主要结局

Proportion of Participants With Recorded Blood Pressure Values in Office

时间窗: 7-10 days post delivery

Proportion of participants with blood pressure values recorded in the office

次要结局

  • Proportion of Participants With Recorded Blood Pressure Values, Any Reporting(7-10 days post delivery)
  • Diastolic Blood Pressure(7-10 days post delivery)
  • Initiated New Medications(7-10 days)
  • Sustained Severe Hypertension, 7-10 Days(7-10 days postpartum)
  • Systolic Blood Pressure, 7-10 Days(7-10 days post delivery)
  • Postpartum Visit Attendance(3-6 weeks post delivery)
  • Primary Care Visit Attendance(3 months post delivery)
  • Unplanned Visits(7-10 days)
  • Systolic Blood Pressure, 4-6 Weeks(4-6 weeks post delivery)
  • Diastolic Blood Pressure, 4-6 Weeks(4-6 weeks post delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Osmundson

Principal Investigator

Vanderbilt University Medical Center

研究点 (1)

Loading locations...

相似试验