Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

NCT05849103 | Completed Results

• 1 other identifier: R21NR020857-01
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pregnancy-Induced; Postpartum Preeclampsia; Hypertension; Maternal

Keywords

Hypertension; Postpartum hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Proportion of Participants With Recorded Blood Pressure Values, Any Reporting

  7-10 days post delivery

• Systolic Blood Pressure, 7-10 Days

  7-10 days post delivery

• Diastolic Blood Pressure

  7-10 days post delivery

• Systolic Blood Pressure, 4-6 Weeks

  4-6 weeks post delivery

• Diastolic Blood Pressure, 4-6 Weeks

  4-6 weeks post delivery

Other Outcomes (4)

• Felt That They Were Treated With Respect

  2 weeks post delivery

• Anxiety

  2 weeks post delivery

• Instrumental Support

  2 weeks post delivery

Study Arms (4)

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.

Other: Blood Pressure Control Targets; Other: Hypertension Management

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.

Other: Blood Pressure Control Targets; Other: Hypertension Management

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.

Other: Blood Pressure Control Targets; Other: Hypertension Management

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.

Other: Blood Pressure Control Targets; Other: Hypertension Management

Interventions

Blood Pressure Control Targets OTHER

This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90

A) Standard BP Control, Clinician Monitoring; B) Tight BP Control, Clinician Monitoring; C) Standard BP Control, Care Navigation; D) Tight BP Control, Care Navigation

Hypertension Management OTHER

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.

A) Standard BP Control, Clinician Monitoring; B) Tight BP Control, Clinician Monitoring; C) Standard BP Control, Care Navigation; D) Tight BP Control, Care Navigation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who have recently given birth. The aim of this study evaluate post-partum hypertension care.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Sarah Osmundson, MD, MS: collaborator
• Alex Phelps, MD: collaborator
• Julia Phillippi, PhD, CNM: collaborator
• Soha Patel, MD, MSPH: collaborator
• Etoi Garrison, MD, PhD: collaborator
• Kathryn Lindley, MD: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

There are important limitations to our study. First, the randomized controlled trial design increases internal validity of our findings but can also decrease external validity. Forty-eight percent of eligible patients did not enroll, raising concerns for how our interventions would perform outside of a research setting. In addition, we were unable to enroll non-English speaking participants, who are an important population to consider especially for larger implementation efforts.

Results Point of Contact

• Title: Sarah Osmundson, MD, MS
• Organization: Vanderbilt University Medical Center

sarah.osmundson@vumc.org

6158752231

Study Officials

• Sarah Osmundson, MD

  Associate Professor Maternal-Fetal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research personnel assessing outcomes will be masked to the intervention
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 8, 2023
• Study Start: May 8, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 12, 2026
• Results First Posted: October 9, 2025

Record last verified: 2026-03

Locations

US (1)