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Comprehensive Postpartum Hypertension Management for High Blood Pressure
N/A
Recruiting
Led By Sarah Osmundson, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Age >18 years
Must not have
Not able or willing to receive electronic surveys
Contraindication to ACOG-recommended hypertension control (i.e. chronic kidney disease, stroke)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post delivery
Awards & highlights
Summary
This trial tests a program to help new mothers with high blood pressure after childbirth. The program includes using an app to track blood pressure, support from a health navigator, and connecting with primary care doctors. It aims to improve blood pressure control and reduce health risks, especially for Black mothers.
Who is the study for?
This trial is for women over 18 who've had high blood pressure issues during pregnancy, like preeclampsia or HELLP Syndrome. They must be able to receive electronic surveys and speak English. Women with conditions that make standard hypertension treatment risky, like kidney disease or stroke, can't join.
What is being tested?
The study tests a comprehensive postpartum care program focusing on self-monitoring blood pressures via an app, management by a navigator with guidelines and physician support, and smooth transition to primary care for ongoing hypertension control. The goal is better outcomes up to three months after birth.
What are the potential side effects?
Since the interventions involve monitoring and managing blood pressure rather than medication trials, direct side effects are not anticipated as part of this study. However, there may be indirect effects from the stress of self-monitoring or potential anxiety from health data tracking.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with a high blood pressure condition during pregnancy.
Select...
I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot or do not want to take surveys electronically.
Select...
I cannot take standard blood pressure medicines due to other health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post delivery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants with recorded blood pressure values in office
Secondary study objectives
Mean diastolic blood pressure, 4-6 weeks post delivery
Mean diastolic blood pressure, 7-10 days
Mean systolic blood pressure, 4-6 weeks post delivery
+9 moreOther study objectives
Edinburgh Postpartum Depression Scale
Mothers on Respect Index Score
Perceived Stress (NIH Toolbox)
+4 moreTrial Design
4Treatment groups
Active Control
Group I: A) Standard BP Control, Clinician MonitoringActive Control2 Interventions
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.
Group II: B) Tight BP Control, Clinician MonitoringActive Control2 Interventions
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.
Group III: C) Standard BP Control, Care NavigationActive Control2 Interventions
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.
Group IV: D) Tight BP Control, Care NavigationActive Control2 Interventions
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for hypertension include lifestyle modifications, self-monitoring of blood pressure, and pharmacological interventions. Self-monitoring allows patients to track their blood pressure regularly, providing real-time data that can help in timely adjustments to treatment plans.
Program navigator-directed BP management involves personalized guidance and support, ensuring adherence to treatment protocols and lifestyle changes. Facilitated care transitions ensure seamless coordination between different healthcare providers, improving overall management and follow-up care.
Pharmacologically, antihypertensive medications such as ACE inhibitors, ARBs, beta-blockers, calcium channel blockers, and diuretics work by various mechanisms: reducing blood volume, dilating blood vessels, and decreasing heart rate, all of which lower blood pressure. These treatments are crucial for hypertension patients as they help prevent complications such as stroke, heart attack, and kidney disease by maintaining blood pressure within a target range.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
893 Previous Clinical Trials
934,272 Total Patients Enrolled
34 Trials studying Hypertension
54,800 Patients Enrolled for Hypertension
Sarah Osmundson, MD, MSUNKNOWN
Alex Phelps, MDUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a high blood pressure condition during pregnancy.I cannot or do not want to take surveys electronically.I cannot take standard blood pressure medicines due to other health issues.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: A) Standard BP Control, Clinician Monitoring
- Group 2: B) Tight BP Control, Clinician Monitoring
- Group 3: C) Standard BP Control, Care Navigation
- Group 4: D) Tight BP Control, Care Navigation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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