RI-SPHERES for Postpartum Hypertension

(RI-SPHERES Trial)

Recruiting at 4 trial locations

Overseen By Stephanie Nunez, Research Coordinator

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Prior enrollment, Prisoners, Inability to consent, others

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

Compensation: Varies

Number of Visits: Unknown

1536 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether 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 RI-SPHERES for postpartum hypertension?

The SNAP-HT Trial showed that self-management of postpartum hypertension, which includes daily home blood pressure monitoring, led to better blood pressure control compared to usual care. This suggests that similar self-measured blood pressure programs, like RI-SPHERES, could be effective in managing postpartum hypertension. ^{1 2 3 4 5}

Is the RI-SPHERES treatment for postpartum hypertension safe for humans?

The research does not provide specific safety data for the RI-SPHERES treatment or similar programs for postpartum hypertension, indicating a need for more studies to determine the safety of these interventions. ^{2 6 7 8 9}

What is the purpose of this trial?

This is a hybrid type 1 non-inferiority implementation effectiveness trial among postpartum patients with hypertension (N=1536) that will test the hypothesis that RI-SPHERES (a technologically enabled collaborative care model) is non-inferior to a standard self-measured blood pressure program in terms of persistent hypertension at six weeks postpartum and preventive care receipt within one year of delivery.

Eligibility Criteria

This trial is for postpartum patients with hypertension. It's designed to see if a new care model called RI-SPHERES, which uses technology and team-based care, can manage blood pressure as effectively as standard self-monitoring after giving birth.

Inclusion Criteria

I am over 18 and gave birth in a Rhode Island hospital.

Smartphone ownership

I was diagnosed with high blood pressure during or after my pregnancy.

Exclusion Criteria

Prisoners or incarcerated people

Inability or unwillingness to provide informed consent

Prior enrollment in this trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Treatment

Participants use a self-measured blood pressure (SMBP) program with a focus on blood pressure control

6 weeks

Daily self-measurements

Transition to Preventive Care

Participants transition to receiving recommended preventive care with continued monitoring

From 6 weeks postpartum until one year postpartum

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months postpartum

Treatment Details

Interventions

• RI-SPHERES
• Standard self-measured blood pressure program

Trial Overview The study compares RI-SPHERES—a tech-enabled collaborative care approach—to the usual way of monitoring blood pressure by oneself in postpartum women with high blood pressure. The goal is to check if this new method prevents long-term hypertension.

Participant Groups

Group I: RI-SPHERES Experimental Treatment 1 Intervention

A technology enabled collaborative care model. Participants will receive a LTE-enabled blood pressure (BP) cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. The first six weeks of the program will focus on BP control, and the remaining time will help transition people to receive recommended preventive care. As part of the collaborative care model, the nurse practitioner will lead weekly meetings with a multidisciplinary clinical team about all enrolled people.

Group II: Standard self-measured blood pressure program Active Control 1 Intervention

Our hospital has a remote hypertension monitoring program that recommends daily blood pressure ascertainment for 6 weeks, at which time they are discharged and provided printed resources to encourage preventive care in the next few months. In this program, patients manually enter their self-measured BPs into the electronic medical record for the clinical team to manually review and respond.

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Kent Hospital, Rhode Island

Collaborator

Trials

4

Recruited

2,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Findings from Research

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]

This randomized controlled trial involving 186 women with postpartum hypertension demonstrated that self-management, which included daily blood pressure monitoring and telemonitoring for medication adjustments, was feasible and led to better blood pressure control compared to usual care.

The intervention group showed significantly lower blood pressure, particularly diastolic pressure, at 6 weeks and maintained better control up to 6 months, suggesting that self-management could be an effective strategy for managing postpartum hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management of Postnatal Hypertension: The SNAP-HT Trial. Cairns, AE., Tucker, KL., Leeson, P., et al.[2021]

In a study of 460 women with hypertensive disorders in pregnancy, 88.7% experienced a return to normal blood pressure levels by 42 days postpartum, indicating a generally positive recovery trend after delivery.

Risk factors that may hinder the recovery of postpartum blood pressure include advanced maternal age, a higher severity of hypertensive disorders during pregnancy, and having both high systolic and diastolic blood pressures, suggesting that these women require closer monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postpartum change of blood pressure and its risk factors in patients with hypertensive disorders in pregnancy]. Shen, L., Tan, H., Zhou, S., et al.[2018]

In a study of 1,964 women, 2.9% developed a postpartum-onset hypertensive disorder, highlighting the need for awareness of this condition after delivery.

Key risk factors for developing postpartum hypertension include assisted reproductive technology, high pre-pregnancy body mass index, chronic nephritis, hypothyroidism, elevated blood pressure during pregnancy, and cesarean delivery, suggesting that women with these factors should be closely monitored for blood pressure changes post-delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical features and antenatal risk factors for postpartum-onset hypertensive disorders. Takaoka, S., Ishii, K., Taguchi, T., et al.[2022]

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]

References

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

Immediate postpartum curettage: accelerated recovery from severe preeclampsia. [2022]

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

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

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

Postpartum preeclampsia management with furosemide: a randomized clinical trial. [2022]

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

Self-Management of Postnatal Hypertension: The SNAP-HT Trial. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Postpartum change of blood pressure and its risk factors in patients with hypertensive disorders in pregnancy]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Clinical features and antenatal risk factors for postpartum-onset hypertensive disorders. [2022]

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

Best Practices for Managing Postpartum Hypertension. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Risk of post-pregnancy hypertension in women with a history of hypertensive disorders of pregnancy: nationwide cohort study. [2022]