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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Comprehensive Postpartum Management for high blood pressure?

The research highlights the importance of managing postpartum hypertension (high blood pressure after childbirth) effectively, as it can lead to serious health issues. While specific data on Comprehensive Postpartum Management is not provided, studies emphasize the need for improved blood pressure monitoring and discharge recommendations, suggesting that structured management plans can help reduce complications and hospital readmissions. ^{1 2 3 4 5}

Is the treatment for postpartum hypertension safe for humans?

There is limited safety data available for postpartum hypertension treatments, but some medications like calcium channel blockers, beta-blockers, alpha-blockers, and ACE inhibitors have been used with varying effectiveness. More research is needed to determine the safest options. ^{4 6 7 8 9}

How is the Comprehensive Postpartum Management treatment different from other treatments for postpartum hypertension?

Comprehensive Postpartum Management is unique because it addresses the lack of standard guidelines for managing high blood pressure after childbirth, focusing on improving blood pressure monitoring and discharge recommendations, which are often inadequate in current practices. ^{1 2 3 4 7}

Research Team

Sarah Osmundson, MD

Principal Investigator

Associate Professor Maternal-Fetal Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hypertension in the postpartum woman: clinical update for the hypertension specialist. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Optimal management of post-discharge postpartum hypertensive disorders of pregnancy: a quality improvement initiative. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Hypertensive Disorders of Pregnancy and Future Maternal Health: How Can the Evidence Guide Postpartum Management? [2023]

4. England pubmed.ncbi.nlm.nih.gov

Postpartum management of hypertensive disorders of pregnancy: a systematic review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Standardized Clinical Assessment and Management Plan to Reduce Readmissions for Postpartum Hypertension. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Best Practices for Managing Postpartum Hypertension. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Clinical management of hypertensive disorders in postpartum women. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Postpartum management of hypertension and effect on readmission rates. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Tight vs liberal control of mild postpartum hypertension: a randomized controlled trial. [2023]