Heart Health Doulas for Hypertensive Disorders of Pregnancy
(HHD Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJanet Catov, PhD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pittsburgh
Must not be taking: Antihypertensives
Disqualifiers: Diabetes, Renal disease, Liver disease, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This is a single site, single-blinded parallel randomized control trial that investigates a multi-level intervention to improve postpartum blood pressure in women with hypertensive disorder pregnancy. The investigators will recruit women diagnosed with a hypertensive disorder of pregnancy, identified between 3rd trimester and 2 weeks post-delivery. The investigators will randomize participants to receive usual care home blood pressure monitoring for 6 weeks versus an intervention of usual care + blood pressure and weight monitoring + a doula trained in heart health. This trial will be conducted in partnership with a local community-based organization, Healthy Start Inc.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it excludes those who were on blood pressure medications within 3 months before conception, so it's best to discuss your specific situation with the trial coordinators.
What data supports the effectiveness of the Heart Health Doula Intervention Program treatment for hypertensive disorders of pregnancy?
The effectiveness of mind-body interventions, which may include supportive care similar to doula services, has been reviewed for women with hypertensive disorders in pregnancy, suggesting potential benefits in managing these conditions.
12345How does the treatment 'Usual Care' for hypertensive disorders of pregnancy differ from other treatments?
The treatment 'Usual Care' for hypertensive disorders of pregnancy is unique because it involves standard medical practices and monitoring without any specialized or experimental interventions, focusing on routine care and management of the condition.
678910Eligibility Criteria
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.Inclusion Criteria
I am pregnant or recently had a baby and was diagnosed with high blood pressure during pregnancy.
Women must reside in Allegheny, Westmoreland, Beaver, Butler, or Washington County. Participant may also reside within 100 miles of Allegheny County
The participant must deliver (or plan to deliver) at Magee-Womens Hospital
Exclusion 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 do not have diabetes.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive usual care home blood pressure monitoring for 6 weeks or an intervention with a doula and additional monitoring
6 weeks
Weekly check-ins (in-person or virtual)
Doula Support
Intervention group receives postpartum doula support and social support group for 8-12 weeks
8-12 weeks
Weekly doula sessions (in-person or virtual)
Follow-up
Participants are monitored for blood pressure and mean arterial pressure (MAP) at 12 months postpartum
12 months
Follow-up visit at 12 months postpartum
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Magee Women's Hospital of UPMCPittsburgh, PA
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Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Postnatal health and care following hypertensive disorders in pregnancy: a prospective cohort study (BPiPP study). [2022]One in 10 women have hypertensive disorders in pregnancy (HDP) and are at risk of adverse short- and long-term health outcomes, yet there is limited information on their postnatal health and care needs. This study aimed to look at postnatal physical and psychological morbidity in women with HDP, compared to women without HDP, and the postnatal care received in both groups.
Challenging the status quo: results of an acceptability and feasibility study of hypertensive disorders of pregnancy (HDP) management pathways in Indonesian primary care. [2023]Hypertensive disorders of pregnancy (HDP) are the leading cause of maternal mortality in Indonesia. Focused HDP management pathways for Indonesian primary care practice have been developed from a consensus development process. However, the acceptability and feasibility of the pathways in practice have not been explored. This study reports on the implementation process of the pathways to determine their acceptability and feasibility in Indonesian practice.
The safety and effectiveness of mind body interventions for women with pregnancy induced hypertension and or preeclampsia: A systematic review and meta-analysis. [2021]To undertake a systematic review of the safety and effectiveness of mind body approaches for women with hypertensive disorders in pregnancy (HDP).
Opportunities for improving hypertensive disorders of pregnancy (HDP) management in primary care settings: A review of international published guidelines in the context of pregnancy care in Indonesia. [2020]Almost all of global maternal mortality caused by HDP occurs in low to middle-income countries (LMIC). However, limited guidance is available to local primary care practitioners who are usually the main health care providers. This review examined existing international practice guidelines to identify potential practices to improve HDP management in Indonesian primary care settings. We performed structured literature search strategies and snowballing searches in six databases (MEDLINE, Web of Science, EMBASE, CINAHL, Cochrane reviews and Google Scholar) for guidelines that were published between 2007 and 2018 using relevant keywords and phrases of 'guidelines', 'hypertensive disorders of pregnancy' or 'preeclampsia' and 'primary care'. The AGREE II instrument was used to assess quality and reporting of the eligible guidelines. Thematic analysis was performed on all of the guidelines and the results were discussed among the project investigators. Sixteen international practice guidelines or similar management recommendations were reviewed. Almost all of them were partially applicable, with some managements potentially able to be adopted to Indonesian primary care settings. Three main themes for improving HDP management were identified, namely clinical management, care planning, and professional communication. These potential improvements in managing women with HDP in Indonesia may also be relevant in other LMIC. Further contextualisation is required to facilitate their adoption in practice settings.
Perinatal Outcome in Women with Hypertensive Disorders of Pregnancy in Rural Tertiary Center of Northern India: A Retrospective Cohort Study". [2021]Hypertensive disorder of pregnancy is associated with adverse maternal, perinatal outcome.
Educational level and self-care behaviour in patients with heart failure before and after nurse educational intervention. [2015]Self-care is important for heart failure (HF) management and may be influenced by the patient's educational level.
Behind the smile: qualitative study of caregivers' anguish and management responses while caring for someone living with heart failure. [2021]Caregivers support self-management in heart failure but often experience stress, anxiety and ill health as a result of providing care.
Heart Failure Caregiver Self-Care: A Latent Class Analysis. [2021]Little is known about heart failure (HF) caregiver self-care. This article reports a secondary analysis of data from a cross-sectional, descriptive study involving 530 HF caregivers. A three-step latent class mixture model identified HF caregiver classes at risk for poor self-care and examined the relationship between the identified self-care classes and caregiver burden and depression. Caregivers completed online surveys on self-care, caregiver burden, depression, problem-solving, social support, and family function. Caregivers were 41.39 (±10.38) years old, 78.3% Caucasian, and 50.9% men. Three classes of HF caregivers (24% Low-Risk, 24.9% Moderate-Risk, 51.1% High-Risk) were identified. High-Risk caregivers had the worst self-care and the lowest levels of social support, problem-solving, and family function. Moderate-Risk caregivers were the most experienced and had the best self-care yet had the most comorbidities. High-Risk caregivers reported more caregiver burden and depression. "At-risk" caregivers may benefit from self-care and support programs, but more research is needed.
[Effect of home hospitalization in the reduction of traditional hospitalization and frequency of emergencies in heart failure]. [2019]Medical care to patients with heart failure (HF) entails high needs in health care and social resources. Hospital at home (HH) is a potentially useful care alternative for these patients.
Home diuretic protocol for heart failure: partnering with home health to improve outcomes and reduce readmissions. [2021]The management of heart failure (HF) is challenging, with high rates of readmission and no single solution. MaineHealth, a health care system serving southern Maine, has shown initial success with home health nurses partnering with physicians in the management of complex patients with HF using the MaineHealth Home Diuretic Protocol (HDP).