What side effects are associated with this type of intervention?

Common treatments for hypertension, such as those in the Comprehensive Postpartum HDP Management Program, include lifestyle modifications, antihypertensive medications, and close monitoring. Antihypertensive medications can cause side effects like dizziness, headaches, fatigue, and gastrointestinal issues. Specific drug classes have unique side effects: ACE inhibitors may cause a dry cough and high potassium levels; beta-blockers can lead to fatigue and cold extremities; calcium channel blockers might cause lower extremity swelling; and diuretics can result in electrolyte imbalances and dehydration. Lifestyle changes generally have fewer side effects but require adherence and behavioral adjustments.

What prior FDA approvals exist?

The FDA has approved a variety of antihypertensive drugs for the treatment of hypertension, including ACE inhibitors (e.g., enalapril, captopril), ARBs (e.g., losartan, valsartan), calcium channel blockers (e.g., amlodipine), and beta-blockers (e.g., metoprolol). These medications are often used in combination with self-monitoring techniques and structured care programs to manage blood pressure effectively. Programs similar to the Comprehensive Postpartum HDP Management Program, which emphasize self-monitoring, program navigator-directed BP management, and facilitated care transitions, are designed to optimize the use of these medications and improve patient outcomes.

What other types of research exist?

Promising alternatives to the Comprehensive Postpartum HDP Management Program for hypertension patients in 2024 include: 1) Automated blood pressure monitoring and urinalysis devices, which offer continuous and accurate monitoring outside clinical settings. 2) Digital health tools such as mobile apps for real-time blood pressure tracking and telehealth consultations. 3) Integration of artificial intelligence to personalize treatment plans based on patient data. 4) Novel antihypertensive medications with improved efficacy and safety profiles. These alternatives can be integrated into existing care frameworks to enhance patient outcomes and provide more personalized and efficient hypertension management.

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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

No Placebo-Only Group

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 below

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I was diagnosed with a high blood pressure condition during pregnancy.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot or do not want to take surveys electronically.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post delivery for reporting.

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 more

Other study objectives

Edinburgh Postpartum Depression Scale

Mothers on Respect Index Score

Perceived Stress (NIH Toolbox)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 4Eligibility criteria met

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.