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OpenTrials
Completed

NCT Number: NCT05849103

Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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) Exclusion Criteria
  • 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)

Treatment and study plan

Blood Pressure Control Targets

Other

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

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.

Primary outcomes

  1. Proportion of Participants With Recorded Blood Pressure Values in Office

    Time frame: 7-10 days post delivery

    Proportion of participants with blood pressure values recorded in the office

Secondary outcomes

  1. Proportion of Participants With Recorded Blood Pressure Values, Any Reporting

    Time frame: 7-10 days post delivery

    Proportion of participants with blood pressure values recorded through any means

  2. Systolic Blood Pressure, 7-10 Days

    Time frame: 7-10 days post delivery

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

  3. Diastolic Blood Pressure

    Time frame: 7-10 days post delivery

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

  4. Systolic Blood Pressure, 4-6 Weeks

    Time frame: 4-6 weeks post delivery

    Mean systolic blood pressure, 4-6 weeks

  5. Diastolic Blood Pressure, 4-6 Weeks

    Time frame: 4-6 weeks post delivery

    Mean diastolic blood pressure, 4-6 weeks

  6. Initiated New Medications

    Time frame: 7-10 days

    Initiated new antihypertensive medications by 7-10 days postpartum

  7. Sustained Severe Hypertension, 7-10 Days

    Time frame: 7-10 days postpartum

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

  8. Unplanned Visits

    Time frame: 7-10 days

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

  9. Postpartum Visit Attendance

    Time frame: 3-6 weeks post delivery

    Proportion of patients with postpartum visit attendance

  10. Primary Care Visit Attendance

    Time frame: 3 months post delivery

    Proportion of patients with primary care visit attendance

Other outcomes

  1. Felt That They Were Treated With Respect

    Time frame: 2 weeks post delivery

    Proportion of participants who responded "good", "very good", or "excellent" to the prompt "My health care team treated me with respect"

  2. Anxiety

    Time frame: 2 weeks post delivery

    Measure of the mean T-score. The T-score rescales the raw score into a standardized T-score with a range of 0-100 where the population mean is 50 and the standard deviation (SD) of 10. In this range 0 is no anxiety and 100 is high anxiety.

  3. Instrumental Support

    Time frame: 2 weeks post delivery

    Measure of the mean T-score. The T-score rescales the raw score into a standardized T-score with a range of 0-100 where the population mean is 50 and the standard deviation (SD) of 10. In this range 0 is no support and 100 is high support.

  4. Mothers on Respect Index Score

    Time frame: 6 weeks post delivery

    The Mothers on Respect (MOR) index was developed to assess the nature of patient-provider interactions and their impact on a person's sense of respect during maternity care. The MOR index is a patient-informed quality and safety indicator that can be applied across jurisdictions to assess the nature of provider-patient relationships, and access to person-centered care. Responses are summed to provide a total score with a range of 18-84 with higher scores indicating more respectful care. A score of 50-66 indicates moderate respect and 67-84 indicates high respect.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Alex Phelps, MD
  • Etoi Garrison, MD, PhD
  • Julia Phillippi, PhD, CNM
  • Kathryn Lindley, MD
  • Sarah Osmundson, MD, MS
  • Soha Patel, MD, MSPH

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 8, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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