Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

Hypertension, Pregnancy-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849103
• Other study ID #: R21NR020857-01
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: April 1, 2028

Study information

• Verified date: June 2024
• Source: Vanderbilt University Medical Center
• Contact: Sarah Osmundson, MD
• Phone: 615-343-5700
• Email: sarah.osmundson[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced
• Postpartum Preeclampsia
• Pre-Eclampsia
• Toxemia

Intervention

Other:
• Blood Pressure Control Targets
This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
• Hypertension Management
This intervention specifies whether the participant has hypertension management through their obstetric clinician or through a single nurse navigator who provides feedback and modifies hypertension treatment based on blood pressure values submitted by the participant.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (7)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Alex Phelps, MD, Etoi Garrison, MD, PhD, Julia Phillippi, PhD, CNM, Kathryn Lindley, MD, Sarah Osmundson, MD, MS, Soha Patel, MD, MSPH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with postpartum care	Scale of 1-10	6 weeks post delivery
Other	Satisfaction with blood pressure care	Scale of 1-10	6 weeks post delivery
Other	Proportion of patients who respond 'yes' to feeling that their voice is heard	Feeling that their voice is heard	2 weeks post delivery
Other	Perceived Stress (NIH Toolbox)	mean T-score (Range 1-100)	2 weeks post delivery
Other	Self-Efficacy (PROMIS measure)	mean T-score (Range 1-100)	2 weeks post delivery
Other	Edinburgh Postpartum Depression Scale	Mean score (range 1-30)	2 weeks post delivery
Other	Mothers on Respect Index Score	mean score (range 14-84)	6 weeks post delivery
Primary	Proportion of participants with recorded blood pressure values in office	Proportion of participants with blood pressure values recorded in the office	7-10 days post delivery
Secondary	Proportion of participants with recorded blood pressure values, any reporting	Proportion of participants with blood pressure values recorded through any means	7-10 days post delivery
Secondary	Mean systolic blood pressure, 7-10 days	Mean systolic blood pressure	7-10 days post delivery
Secondary	Mean diastolic blood pressure, 7-10 days	Mean diastolic blood pressure	7-10 days post delivery
Secondary	Mean systolic blood pressure, 4-6 weeks post delivery	Mean systolic blood pressure	4-6 weeks post delivery
Secondary	Mean diastolic blood pressure, 4-6 weeks post delivery	Mean diastolic blood pressure	4-6 weeks post delivery
Secondary	Proportion of patients who initiated or increased medications	Initiated or increased medications	6 weeks post delivery
Secondary	Number of contacts with the health care team	Number of contacts with the health care team	6 weeks post delivery
Secondary	Proportion of patients with sustained severe hypertension	Two blood pressures >=160/100 at least 15 minutes apart	6 weeks post delivery
Secondary	Proportion of patients with obstetric triage or emergency department visit	Obstetric triage or emergency department visit	6 weeks post delivery
Secondary	Proportion of patients with hospital readmission for hypertension	Hospital readmission for hypertension	6 weeks post delivery
Secondary	Proportion of patients with postpartum visit attendance	Postpartum visit attendance	3-6 weeks post delivery
Secondary	Proportion of patients with primary care visit attendance	Primary care visit attendance	3 months post delivery