- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05849103
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy: A Randomized Controlled
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah Osmundson, MD
- Phone Number: 615-343-5700
- Email: sarah.osmundson@vumc.org
Study Contact Backup
- Name: Ashudee Kirk
- Phone Number: 6153439933
- Email: ashudee.kirk@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37215
- Recruiting
- Vanderbilt University Medical Center
-
Contact:
- Sarah Osmundson, MD MS
- Phone Number: 615-343-7869
- Email: sarah.osmundson@vanderbilt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
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.
|
Active Comparator: 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.
|
This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
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.
|
Active Comparator: 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.
|
This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
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.
|
Active Comparator: 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.
|
This intervention specifies the goal blood pressure as less than 150/100 versus less than 140/90
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7-10 days post delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7-10 days post delivery
|
Mean systolic blood pressure, 7-10 days
Time Frame: 7-10 days post delivery
|
Mean systolic blood pressure
|
7-10 days post delivery
|
Mean diastolic blood pressure, 7-10 days
Time Frame: 7-10 days post delivery
|
Mean diastolic blood pressure
|
7-10 days post delivery
|
Mean systolic blood pressure, 4-6 weeks post delivery
Time Frame: 4-6 weeks post delivery
|
Mean systolic blood pressure
|
4-6 weeks post delivery
|
Mean diastolic blood pressure, 4-6 weeks post delivery
Time Frame: 4-6 weeks post delivery
|
Mean diastolic blood pressure
|
4-6 weeks post delivery
|
Proportion of patients with postpartum visit attendance
Time Frame: 3-6 weeks post delivery
|
Postpartum visit attendance
|
3-6 weeks post delivery
|
Proportion of patients who initiated or increased medications
Time Frame: 6 weeks post delivery
|
Initiated or increased medications
|
6 weeks post delivery
|
Number of contacts with the health care team
Time Frame: 6 weeks post delivery
|
Number of contacts with the health care team
|
6 weeks post delivery
|
Proportion of patients with sustained severe hypertension
Time Frame: 6 weeks post delivery
|
Two blood pressures >=160/100 at least 15 minutes apart
|
6 weeks post delivery
|
Proportion of patients with obstetric triage or emergency department visit
Time Frame: 6 weeks post delivery
|
Obstetric triage or emergency department visit
|
6 weeks post delivery
|
Proportion of patients with hospital readmission for hypertension
Time Frame: 6 weeks post delivery
|
Hospital readmission for hypertension
|
6 weeks post delivery
|
Proportion of patients with primary care visit attendance
Time Frame: 3 months post delivery
|
Primary care visit attendance
|
3 months post delivery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who respond 'yes' to feeling that their voice is heard
Time Frame: 2 weeks post delivery
|
Feeling that their voice is heard
|
2 weeks post delivery
|
Perceived Stress (NIH Toolbox)
Time Frame: 2 weeks post delivery
|
mean T-score (Range 1-100)
|
2 weeks post delivery
|
Self-Efficacy (PROMIS measure)
Time Frame: 2 weeks post delivery
|
mean T-score (Range 1-100)
|
2 weeks post delivery
|
Edinburgh Postpartum Depression Scale
Time Frame: 2 weeks post delivery
|
Mean score (range 1-30)
|
2 weeks post delivery
|
Mothers on Respect Index Score
Time Frame: 6 weeks post delivery
|
mean score (range 14-84)
|
6 weeks post delivery
|
Satisfaction with postpartum care
Time Frame: 6 weeks post delivery
|
Scale of 1-10
|
6 weeks post delivery
|
Satisfaction with blood pressure care
Time Frame: 6 weeks post delivery
|
Scale of 1-10
|
6 weeks post delivery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sarah Osmundson, MD, Associate Professor Maternal-Fetal Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21NR020857-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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