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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post delivery
Awards & highlights

Study Summary

This trial proposes a program to reduce hypertensive disorders of pregnancy risks and improve outcomes for postpartum patients. It includes app-based monitoring, program navigation and facilitated transition of care. Outcomes will be evaluated to reduce disparities in hypertensive disorders of pregnancy.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with recorded blood pressure values in office
Secondary outcome measures
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 outcome measures
Edinburgh Postpartum Depression Scale
Mothers on Respect Index Score
Perceived Stress (NIH Toolbox)
+4 more

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.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
671,893 Total Patients Enrolled
33 Trials studying Hypertension
48,316 Patients Enrolled for Hypertension
Sarah Osmundson, MD, MSUNKNOWN
Alex Phelps, MDUNKNOWN

Media Library

Comprehensive Postpartum Management Clinical Trial Eligibility Overview. Trial Name: NCT05849103 — N/A
Hypertension Research Study Groups: A) Standard BP Control, Clinician Monitoring, B) Tight BP Control, Clinician Monitoring, C) Standard BP Control, Care Navigation, D) Tight BP Control, Care Navigation
Hypertension Clinical Trial 2023: Comprehensive Postpartum Management Highlights & Side Effects. Trial Name: NCT05849103 — N/A
Comprehensive Postpartum Management 2023 Treatment Timeline for Medical Study. Trial Name: NCT05849103 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrolments still open for this research trial?

"Clinicaltrials.gov currently lists this research study as open for recruitment and offers information pertaining to its inception (May 8th, 2023) and most recent update (also May 8th, 2023)."

Answered by AI

What is the maximum subject count for this research project?

"Absolutely. Data hosted on clinicaltrials.gov attests that this medical study, which was initially posted on May 8th 2023, is currently recruiting patients. Approximately 300 participants need to be recruited from 1 centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
Sarah Osmundson 2023. "Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05849103.
All > Womens Health
~200 spots leftby Apr 2027
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