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Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05849103
Enrollment
343
Registered
2023-05-08
Start date
2023-05-08
Completion date
2024-08-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Hypertension, Postpartum hypertension

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.

Interventions

OTHERBlood Pressure Control Targets

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

OTHERHypertension 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Research personnel assessing outcomes will be masked to the intervention

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Participants With Recorded Blood Pressure Values in Office7-10 days post deliveryProportion of participants with blood pressure values recorded in the office

Secondary

MeasureTime frameDescription
Proportion of Participants With Recorded Blood Pressure Values, Any Reporting7-10 days post deliveryProportion of participants with blood pressure values recorded through any means
Systolic Blood Pressure, 7-10 Days7-10 days post deliveryMean difference in systolic blood pressure from baseline, 7-10 days
Diastolic Blood Pressure7-10 days post deliveryMean difference in diastolic blood pressure from baseline, 7-10 days
Systolic Blood Pressure, 4-6 Weeks4-6 weeks post deliveryMean systolic blood pressure, 4-6 weeks
Diastolic Blood Pressure, 4-6 Weeks4-6 weeks post deliveryMean diastolic blood pressure, 4-6 weeks
Initiated New Medications7-10 daysInitiated new antihypertensive medications by 7-10 days postpartum
Sustained Severe Hypertension, 7-10 Days7-10 days postpartumProportion of participants with two blood pressures \>=160/100 at least 15 minutes apart
Unplanned Visits7-10 daysProportion of patients with obstetric triage visits, emergency department visits, or hospital readmission
Postpartum Visit Attendance3-6 weeks post deliveryProportion of patients with postpartum visit attendance
Primary Care Visit Attendance3 months post deliveryProportion of patients with primary care visit attendance

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSarah Osmundson, MD

Associate Professor Maternal-Fetal Medicine

Participant flow

Participants by arm

ArmCount
A) Standard BP Control, Clinician Monitoring
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. 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.
84
B) Tight BP Control, Clinician Monitoring
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. 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.
82
C) Standard BP Control, Care Navigation
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. 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.
83
D) Tight BP Control, Care Navigation
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. 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.
85
Total334

Baseline characteristics

CharacteristicA) Standard BP Control, Clinician MonitoringB) Tight BP Control, Clinician MonitoringC) Standard BP Control, Care NavigationD) Tight BP Control, Care NavigationTotal
Age, Continuous29.0 years30.5 years30.0 years30.0 years30.0 years
Race/Ethnicity, Customized
Race or Ethnicity
Asian
2 Participants4 Participants0 Participants2 Participants8 Participants
Race/Ethnicity, Customized
Race or Ethnicity
Hispanic
11 Participants0 Participants8 Participants7 Participants26 Participants
Race/Ethnicity, Customized
Race or Ethnicity
Multi-racial
5 Participants4 Participants2 Participants5 Participants16 Participants
Race/Ethnicity, Customized
Race or Ethnicity
Non-Hispanic Black
21 Participants20 Participants24 Participants24 Participants89 Participants
Race/Ethnicity, Customized
Race or Ethnicity
Non-Hispanic White
43 Participants49 Participants47 Participants45 Participants184 Participants
Race/Ethnicity, Customized
Race or Ethnicity
Unknown
2 Participants5 Participants2 Participants2 Participants11 Participants
Region of Enrollment
United States
84 participants82 participants83 participants85 participants334 participants
Sex: Female, Male
Female
84 Participants82 Participants83 Participants85 Participants334 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 840 / 820 / 830 / 85
other
Total, other adverse events
0 / 840 / 820 / 830 / 85
serious
Total, serious adverse events
0 / 840 / 820 / 830 / 85

Outcome results

Primary

Proportion of Participants With Recorded Blood Pressure Values in Office

Proportion of participants with blood pressure values recorded in the office

Time frame: 7-10 days post delivery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
A) Standard BP Control, Clinician MonitoringProportion of Participants With Recorded Blood Pressure Values in Office43 Participants
B) Tight BP Control, Clinician MonitoringProportion of Participants With Recorded Blood Pressure Values in Office44 Participants
C) Standard BP Control, Care NavigationProportion of Participants With Recorded Blood Pressure Values in Office49 Participants
D) Tight BP Control, Care NavigationProportion of Participants With Recorded Blood Pressure Values in Office56 Participants
Secondary

Diastolic Blood Pressure

Mean difference in diastolic blood pressure from baseline, 7-10 days

Time frame: 7-10 days post delivery

Population: Participants

ArmMeasureValue (MEDIAN)
A) Standard BP Control, Clinician MonitoringDiastolic Blood Pressure84 mmHg
B) Tight BP Control, Clinician MonitoringDiastolic Blood Pressure82 mmHg
C) Standard BP Control, Care NavigationDiastolic Blood Pressure84 mmHg
D) Tight BP Control, Care NavigationDiastolic Blood Pressure84 mmHg
Secondary

Diastolic Blood Pressure, 4-6 Weeks

Mean difference in diastolic blood pressure from baseline, 4-6 weeks after delivery

Time frame: 4-6 weeks post delivery

Secondary

Initiated New Medications

Initiated new antihypertensive medications by 7-10 days postpartum

Time frame: 7-10 days

Population: Participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
A) Standard BP Control, Clinician MonitoringInitiated New Medications9 Participants
B) Tight BP Control, Clinician MonitoringInitiated New Medications7 Participants
C) Standard BP Control, Care NavigationInitiated New Medications4 Participants
D) Tight BP Control, Care NavigationInitiated New Medications17 Participants
Secondary

Postpartum Visit Attendance

Proportion of patients with postpartum visit attendance

Time frame: 3-6 weeks post delivery

Secondary

Primary Care Visit Attendance

Proportion of patients with primary care visit attendance

Time frame: 3 months post delivery

Secondary

Proportion of Participants With Recorded Blood Pressure Values, Any Reporting

Proportion of participants with blood pressure values recorded through any means

Time frame: 7-10 days post delivery

ArmMeasureValue (NUMBER)
A) Standard BP Control, Clinician MonitoringProportion of Participants With Recorded Blood Pressure Values, Any Reporting48 participants
B) Tight BP Control, Clinician MonitoringProportion of Participants With Recorded Blood Pressure Values, Any Reporting47 participants
C) Standard BP Control, Care NavigationProportion of Participants With Recorded Blood Pressure Values, Any Reporting76 participants
D) Tight BP Control, Care NavigationProportion of Participants With Recorded Blood Pressure Values, Any Reporting78 participants
Secondary

Sustained Severe Hypertension, 7-10 Days

Proportion of participants with two blood pressures \>=160/100 at least 15 minutes apart

Time frame: 7-10 days postpartum

Population: Participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
A) Standard BP Control, Clinician MonitoringSustained Severe Hypertension, 7-10 Days6 Participants
B) Tight BP Control, Clinician MonitoringSustained Severe Hypertension, 7-10 Days5 Participants
C) Standard BP Control, Care NavigationSustained Severe Hypertension, 7-10 Days6 Participants
D) Tight BP Control, Care NavigationSustained Severe Hypertension, 7-10 Days9 Participants
Secondary

Systolic Blood Pressure, 4-6 Weeks

Mean difference in systolic blood pressure from baseline, 4-6 weeks

Time frame: 4-6 weeks post delivery

Secondary

Systolic Blood Pressure, 7-10 Days

Mean difference in systolic blood pressure from baseline, 7-10 days

Time frame: 7-10 days post delivery

ArmMeasureValue (MEDIAN)
A) Standard BP Control, Clinician MonitoringSystolic Blood Pressure, 7-10 Days130 mmHg
B) Tight BP Control, Clinician MonitoringSystolic Blood Pressure, 7-10 Days132 mmHg
C) Standard BP Control, Care NavigationSystolic Blood Pressure, 7-10 Days128 mmHg
D) Tight BP Control, Care NavigationSystolic Blood Pressure, 7-10 Days128 mmHg
Secondary

Unplanned Visits

Proportion of patients with obstetric triage visits, emergency department visits, or hospital readmission

Time frame: 7-10 days

Population: Participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
A) Standard BP Control, Clinician MonitoringUnplanned Visits13 Participants
B) Tight BP Control, Clinician MonitoringUnplanned Visits10 Participants
C) Standard BP Control, Care NavigationUnplanned Visits10 Participants
D) Tight BP Control, Care NavigationUnplanned Visits12 Participants
Other Pre-specified

Feeling That Their Voice is Heard

Proportion of patients who respond 'yes' to feeling that their voice is heard

Time frame: 2 weeks post delivery

Other Pre-specified

Mothers on Respect Index Score

mean score (range 14-84) for the Mothers on Respect Index Score

Time frame: 6 weeks post delivery

Other Pre-specified

Perceived Stress

mean T-score (Range 1-100) using NIH Toolbox

Time frame: 2 weeks post delivery

Other Pre-specified

Self-Efficacy

mean T-score (Range 1-100) on Self-efficacy PROMIS measure

Time frame: 2 weeks post delivery

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026