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Heart Health Doulas for Hypertensive Disorders of Pregnancy (HHD Trial)
N/A
Recruiting
Led By Janet Catov, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months postpartum
Awards & highlights
HHD Trial Summary
This trial investigates a multi-level intervention to reduce postpartum blood pressure in women with hypertensive disorder pregnancy. It involves monitoring, weight and a doula trained in heart health.
Who is the study for?
This trial is for pregnant or postpartum women in certain counties of Pennsylvania, diagnosed with hypertensive disorders like pre-eclampsia during the third trimester to two weeks after delivery. They must plan to deliver at Magee-Womens Hospital and not have chronic conditions affecting blood pressure, diabetes, severe kidney/liver disease, or lupus.Check my eligibility
What is being tested?
The study compares usual care with a Heart Health Doula Intervention Program that includes home monitoring of blood pressure and weight plus support from a doula trained in heart health. Women are randomly assigned to one of these two approaches to see if the intervention improves postpartum blood pressure control.See study design
What are the potential side effects?
Since this trial involves non-medical interventions such as monitoring and doula support rather than drugs or medical procedures, there are no direct side effects associated with typical clinical trials. However, participants may experience stress or discomfort related to frequent health monitoring.
HHD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess MAP at 12 months postpartum
Secondary outcome measures
Assess Racial Disparities in Healthcare Delivery
Change from baseline in racial disparities and blood pressure & MAP at 12 months
HHD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Postpartum Doula Intervention GroupExperimental Treatment2 Interventions
The intervention group will receive study devices (blood pressure cuff, scales, etc.) and instructions on 10-12 months of remote blood pressure, and weight monitoring. An electronic referral will be sent to the Healthy Start program to initiate postpartum Doula support for 8-12 weeks, and a Doula moderated social support group for 6 months. The postpartum Doula will deliver a heart health focused intervention aimed at reducing blood pressure by approximately 12 weeks postpartum.
Group II: Usual Care GroupActive Control1 Intervention
The usual care group will receive remote blood pressure monitoring for approximately 6 weeks via the clinical home blood pressure monitoring program at Magee Women's Hospital of UPMC and be discharged after delivery as usual. This monitoring is standardly offered to women post-delivery with hypertensive disorders of pregnancy. Participants will text in their blood pressures to the medical record systems and be monitored by clinical staff.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,723 Previous Clinical Trials
16,342,702 Total Patients Enrolled
2 Trials studying Malnutrition
269 Patients Enrolled for Malnutrition
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,215,905 Total Patients Enrolled
1 Trials studying Malnutrition
299 Patients Enrolled for Malnutrition
Janet Catov, PhDPrincipal InvestigatorUniversity of Pittsburgh
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had high blood pressure or taken blood pressure medicine in the 3 months before getting pregnant.I do not have severe kidney, liver disease, or lupus.I am pregnant or recently had a baby and was diagnosed with high blood pressure during pregnancy.I do not have diabetes.I am a woman over 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Group
- Group 2: Postpartum Doula Intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being accepted for this clinical experiment?
"As per the information hosted on clinicaltrials.gov, this trial is not presently enlisting participants. This medical study was initially posted on January 1st 2023 and final updated on December 15th 2022 - but there are 3,432 other studies searching for patients right now."
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