Comprehensive Postpartum Hypertension Management for High Blood Pressure

Overseen By Ashudee Kirk

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Non-English speaking, Chronic kidney disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage high blood pressure after childbirth, focusing on conditions like preeclampsia or chronic hypertension. The trial compares different approaches, including a phone app for blood pressure tracking and nurse-guided treatment. Participants will join one of four groups to determine which method best controls blood pressure and reduces health risks. Women diagnosed with a hypertensive disorder of pregnancy who can use electronic surveys might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance postpartum care for many women.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this comprehensive postpartum management program is safe for postpartum hypertension management?

Research has shown that managing blood pressure after childbirth is safe and effective. One study found that home blood pressure monitoring improved tracking and reduced disparities in care among different racial groups. Maintaining tight blood pressure control, below certain levels, has been linked to fewer emergency visits for high blood pressure issues.

For postpartum care, starting medication is recommended if blood pressure is high (140/90 mm Hg or above). This approach can help control blood pressure and prevent serious health issues.

Overall, managing blood pressure after childbirth is generally well-tolerated and helps maintain control, avoiding complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Comprehensive Postpartum Hypertension Management trial because it explores innovative strategies for controlling high blood pressure in new mothers. Unlike traditional care, which often relies solely on clinician monitoring, this approach integrates nurse navigators who actively review and respond to patients' blood pressure readings. This method provides personalized feedback and adjusts medication regimes more proactively. By incorporating care navigation, the trial aims to enhance patient engagement, improve blood pressure control, and potentially reduce complications associated with postpartum hypertension.

What evidence suggests that this trial's treatments could be effective for postpartum hypertension?

Research has shown that controlling high blood pressure after childbirth can greatly lower health risks. In this trial, participants will join different treatment arms to manage their blood pressure. Some will aim to keep blood pressure below 140/90, which studies have found reduces the need for emergency visits. Others will target a blood pressure of less than 150/100. The trial will also explore tools like telemedicine (remote check-ups) and care navigators, who assist by reviewing blood pressure readings and suggesting medication changes if needed. These methods aim to help new mothers manage their blood pressure and avoid complications. ^{2 3 4 5 6}

Who Is on the Research Team?

Sarah Osmundson, MD

Principal Investigator

Associate Professor Maternal-Fetal Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am older than 18 years.

Exclusion Criteria

Deemed inappropriate for study enrollment by the bedside nurse

I cannot or do not want to take surveys electronically.

I cannot take standard blood pressure medicines due to other health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants are randomized and begin self-monitoring of blood pressures with app-based reporting, guided by a program navigator and physician support.

6 weeks

Daily self-monitoring, weekly navigator reviews

Follow-up

Participants are monitored for blood pressure control and other health outcomes, with facilitated transitions to primary care clinicians for ongoing hypertension management.

3 months

1 visit with primary care clinician or cardiologist

Postpartum Care

Participants receive ongoing postpartum care, including blood pressure management and addressing any severe maternal morbidity.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Postpartum Management

Trial Overview

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.

How Is the Trial Designed?

Group I: A) Standard BP Control, Clinician Monitoring Active Control 2 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 Monitoring Active Control 2 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 Navigation Active Control 2 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 Navigation Active Control 2 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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Sarah Osmundson, MD, MS

Collaborator

Trials

1

Recruited

300+

Alex Phelps, MD

Collaborator

Trials

1

Recruited

300+

Julia Phillippi, PhD, CNM

Collaborator

Trials

1

Recruited

300+

Soha Patel, MD, MSPH

Collaborator

Trials

1

Recruited

300+

Etoi Garrison, MD, PhD

Collaborator

Trials

1

Recruited

300+

Kathryn Lindley, MD

Collaborator

Trials

1

Recruited

300+

Published Research Related to This Trial

In a study of 3480 women with peripartum hypertension, those who had high blood pressure (≥140 mm Hg systolic or ≥90 mm Hg diastolic) in the 12 hours before discharge were at a significantly increased risk of readmission for hypertensive complications, regardless of whether they were prescribed antihypertensive medications.

Women discharged with antihypertensive prescriptions who still had elevated blood pressure before leaving the hospital faced a threefold increased risk of readmission, emphasizing the need for effective blood pressure management prior to discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum management of hypertension and effect on readmission rates. Lovgren, T., Connealy, B., Yao, R., et al.[2022]

A systematic review of 39 studies involving 2901 postnatal women with hypertensive disorders of pregnancy found that while calcium-channel blockers, vasodilators, and beta-blockers can lower blood pressure postpartum, there is insufficient evidence to recommend any specific pharmacological intervention due to variability in effectiveness.

Uterine curettage was shown to significantly reduce blood pressure in the first 48 hours postpartum compared to standard care, but safety data was limited, preventing a strong recommendation for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum management of hypertensive disorders of pregnancy: a systematic review. Cairns, AE., Pealing, L., Duffy, JMN., et al.[2023]

There is currently no strong evidence to recommend a specific treatment for postpartum hypertension, as highlighted by a review of 23 studies, indicating a significant gap in research.

Calcium channel blockers, beta-blockers, alpha-blockers, and ACE inhibitors showed varying effectiveness, but more comparative studies are needed to determine the best therapy for managing high blood pressure after delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of hypertensive disorders in postpartum women. Scudo, M., Petruzziello, L., Carbone, F., et al.[2022]

Postpartum women with a history of hypertensive disorders of pregnancy are at increased risk for future cardiovascular issues, highlighting the need for better understanding and management of their health during this period.

Home blood pressure monitoring has shown promise in identifying masked hypertension in these women, suggesting that proactive monitoring could help mitigate long-term health risks associated with hypertensive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertensive Disorders of Pregnancy and Future Maternal Health: How Can the Evidence Guide Postpartum Management? Hauspurg, A., Countouris, ME., Catov, JM.[2023]

Diuretics have been shown to effectively reduce postpartum hypertension in women with hypertensive disorders of pregnancy, highlighting a potential treatment option for managing this condition.

Innovations like telemedicine and machine learning risk prediction models are enhancing the monitoring and management of postpartum hypertension, which may lead to better long-term health outcomes for women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practices for Managing Postpartum Hypertension. Kumar, NR., Hirshberg, A., Srinivas, SK.[2022]

Postpartum hypertension can either continue from pregnancy or develop after delivery, posing significant risks to maternal health, especially due to reduced medical monitoring after discharge.

There is a lack of clear guidelines for managing postpartum hypertension, which can lead to misdiagnosis and inappropriate treatment, highlighting the need for hypertension specialists to be involved in postpartum care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension in the postpartum woman: clinical update for the hypertension specialist. Ghuman, N., Rheiner, J., Tendler, BE., et al.[2022]

Implementing a standardized clinical assessment and management plan for postpartum hypertension significantly reduced readmissions and emergency department visits, with only 2.8% of patients in the postintervention group experiencing these outcomes compared to 11.0% in the historical control group.

Outpatient remote blood pressure monitoring and timely medication adjustments were crucial for managing hypertension after discharge, particularly for high-risk groups, highlighting the importance of follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Clinical Assessment and Management Plan to Reduce Readmissions for Postpartum Hypertension. Mei, JY., Corry-Saavedra, K., Nguyen, TA., et al.[2023]

A study involving 256 postpartum women found that starting antihypertensive treatment at a lower threshold of 140/90 mm Hg did not reduce maternal morbidity compared to a higher threshold of 150/95 mm Hg.

Both groups experienced similar rates of complications and secondary outcomes, indicating that the lower threshold may not provide additional benefits in managing postpartum hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tight vs liberal control of mild postpartum hypertension: a randomized controlled trial. Aderibigbe, OA., Hackney, DN., Ranzini, AC., et al.[2023]

In a study of 224 women experiencing postpartum hypertensive disorders, optimal management was achieved in 65% of cases, indicating a need for improvement in care practices.

While diagnosis and lab work were well-handled, the study found that blood pressure monitoring and discharge recommendations were inadequate, suggesting that better guidelines are needed for postpartum care in women at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal management of post-discharge postpartum hypertensive disorders of pregnancy: a quality improvement initiative. Tanguay Lecomte, A., Vittoz, L., Sauvé, N., et al.[2023]

Citations

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ahajournals.org

ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum

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pmc.ncbi.nlm.nih.gov

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Best Practices for Managing Postpartum Hypertension - PMC

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Advances in postpartum hypertension management

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Comprehensive Postpartum Management for Women With ...

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