Clinical trial NCT05849103: Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
Official title: Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension, Pregnancy-Induced
Postpartum Preeclampsia
Hypertension; Maternal
Keywords: Hypertension
Postpartum hypertension
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Sarah Osmundson, MD, MS
name: Alex Phelps, MD
name: Julia Phillippi, PhD, CNM
name: Soha Patel, MD, MSPH
name: Etoi Garrison, MD, PhD
name: Kathryn Lindley, MD
First posted: 2023-05-08
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A factorial study design will be used where participants will be randomized in a 1:1:1:1 ratio to two intervention types (blood pressure target, hypertension care model) or four total interventions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

1. Age \>18 years
2. 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) Exclusion Criteria

1. Not able or willing to receive electronic surveys 2. Deemed inappropriate for study enrollment by the bedside nurse 3. Non-English speaking 4. Contraindication to ACOG-recommended hypertension control (i.e. chronic kidney disease, stroke)

Primary outcomes:
measure: Proportion of participants with recorded blood pressure values in office
timeFrame: 7-10 days post delivery
Secondary outcomes:
measure: Proportion of participants with recorded blood pressure values, any reporting
timeFrame: 7-10 days post delivery
measure: Mean systolic blood pressure, 7-10 days
timeFrame: 7-10 days post delivery
measure: Mean diastolic blood pressure, 7-10 days
timeFrame: 7-10 days post delivery
measure: Mean systolic blood pressure, 4-6 weeks post delivery
timeFrame: 4-6 weeks post delivery
measure: Mean diastolic blood pressure, 4-6 weeks post delivery
timeFrame: 4-6 weeks post delivery
measure: Proportion of patients who initiated or increased medications
timeFrame: 6 weeks post delivery
measure: Number of contacts with the health care team
timeFrame: 6 weeks post delivery
measure: Proportion of patients with sustained severe hypertension
timeFrame: 6 weeks post delivery
measure: Proportion of patients with obstetric triage or emergency department visit
timeFrame: 6 weeks post delivery
measure: Proportion of patients with hospital readmission for hypertension
timeFrame: 6 weeks post delivery
measure: Proportion of patients with postpartum visit attendance
timeFrame: 3-6 weeks post delivery
measure: Proportion of patients with primary care visit attendance
timeFrame: 3 months post delivery
Other outcomes:
measure: Satisfaction with postpartum care
timeFrame: 6 weeks post delivery
measure: Satisfaction with blood pressure care
timeFrame: 6 weeks post delivery
measure: Proportion of patients who respond 'yes' to feeling that their voice is heard
timeFrame: 2 weeks post delivery
measure: Perceived Stress (NIH Toolbox)
timeFrame: 2 weeks post delivery
measure: Self-Efficacy (PROMIS measure)
timeFrame: 2 weeks post delivery
measure: Edinburgh Postpartum Depression Scale
timeFrame: 2 weeks post delivery
measure: Mothers on Respect Index Score
timeFrame: 6 weeks post delivery
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Associate Professor Maternal-Fetal Medicine
name: Sarah Osmundson, MD
role: PRINCIPAL_INVESTIGATOR
References: