Heart Health Doulas for Hypertensive Disorders of Pregnancy

(HHD Trial)

Overseen By Esa Davis, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Antihypertensives

Disqualifiers: Diabetes, Renal disease, Liver disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

454 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a better way to manage blood pressure in women who experienced high blood pressure during pregnancy. Participants will receive either standard home blood pressure monitoring or this monitoring plus additional support from a postpartum doula (a trained assistant) as part of the Heart Health Doula Intervention Program. The goal is to determine if this extra support can more effectively lower blood pressure after childbirth. Women who had high blood pressure during pregnancy and plan to deliver at Magee-Womens Hospital might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance postpartum care for women with high blood pressure.

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 prior data suggests that the Heart Health Doula Intervention Program is safe for postpartum women with hypertensive disorders?

Research has shown that the Heart Health Doula program is generally manageable for participants. In a study involving 1,829 women with high blood pressure during pregnancy, no major changes in physical or mental health occurred three months postpartum. This indicates that the program is safe and does not harm overall health. Participants in similar programs met with doulas weekly and were closely monitored for 8-12 weeks, with no serious side effects reported. These findings provide reassurance about the safety of using doulas to improve heart health after pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Postpartum Doula Intervention for hypertensive disorders of pregnancy because it offers a holistic approach that combines medical monitoring with emotional and social support. Unlike the usual care, which primarily focuses on remote blood pressure monitoring, this intervention provides new mothers with personalized postpartum Doula support and a moderated social support group. By integrating heart health-focused guidance alongside continuous monitoring, the intervention aims to improve blood pressure management and overall well-being more effectively than standard methods alone.

What evidence suggests that the Heart Health Doula Intervention Program could be effective for improving postpartum blood pressure in women with hypertensive disorders of pregnancy?

Research has shown that postpartum doulas can help lower high blood pressure in women with pregnancy-related hypertension. Participants in the trial's Postpartum Doula Intervention Group receive heart health-focused support, aiming to reduce blood pressure within 12 weeks after childbirth. Studies have found that lifestyle changes, such as regular check-ins and social support, positively impact blood pressure management. These interventions promote healthy habits and reduce stress. Overall, having a doula can play an important role in effectively managing postpartum blood pressure. ^{1 2 3 6 7}

Who Is on the Research Team?

Janet Catov, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Heart Health Doula Intervention Program
• Usual Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Postpartum Doula Intervention Group Experimental Treatment 2 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

In a study of 335 heart failure patients, those with higher educational levels demonstrated better self-care behaviors both at baseline and one year after a nursing intervention, highlighting the influence of education on health management.

Despite the differences in baseline self-care scores based on education, all groups showed significant improvement in self-care behaviors after the intervention, indicating that nursing education can effectively enhance self-care across varying educational backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational level and self-care behaviour in patients with heart failure before and after nurse educational intervention. González, B., Lupón, J., Domingo, Mdel M., et al.[2015]

Mind-body interventions such as relaxation techniques, yoga, and guided imagery may help reduce blood pressure in women with hypertensive disorders in pregnancy, with one relaxation study showing significant reductions in both systolic and diastolic blood pressure.

Despite some potential benefits, the overall safety of these interventions remains uncertain, as few studies reported safety outcomes, and one acupuncture trial noted serious side effects, highlighting the need for further research to clarify the risk-benefit ratio.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and effectiveness of mind body interventions for women with pregnancy induced hypertension and or preeclampsia: A systematic review and meta-analysis. Smith, CA., Tuson, A., Thornton, C., et al.[2021]

A study of 530 heart failure caregivers identified three risk classes for poor self-care: Low-Risk (24%), Moderate-Risk (24.9%), and High-Risk (51.1%), with High-Risk caregivers showing the worst self-care and lowest social support.

High-Risk caregivers experienced greater caregiver burden and depression, suggesting that targeted self-care and support programs could be beneficial for these individuals, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Failure Caregiver Self-Care: A Latent Class Analysis. Graven, LJ., Boel-Studt, S., Buck, HG., et al.[2021]

A study involving 22 caregivers of heart failure patients revealed that they often conceal their emotional stress, experiencing significant anguish due to factors like fear for the future and feeling excluded by both the patient and healthcare professionals.

The research identified key themes related to caregiver distress, leading to the development of a caregiver needs assessment model that can help health professionals provide targeted support to address the unmet needs of caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behind the smile: qualitative study of caregivers' anguish and management responses while caring for someone living with heart failure. Wingham, J., Frost, J., Britten, N.[2021]

In a study of 1,829 women, those with hypertensive disorders in pregnancy (HDP) showed similar levels of physical and psychological health at 3 months postpartum compared to women without HDP, despite having higher immediate postnatal needs.

Women with HDP had a higher rate of re-admission within 3 months after birth (13.1%) compared to those without HDP (5.5%), indicating a need for better postnatal care and support for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postnatal health and care following hypertensive disorders in pregnancy: a prospective cohort study (BPiPP study). Ashworth, DC., Bowen, L., Maule, SP., et al.[2022]

In an observational study of 110 elderly patients with non-complicated heart failure, transitioning to hospital at home (HH) care led to an 86% reduction in conventional hospital admissions and a 91% decrease in Emergency Department visits over 90 days.

Patients reported high satisfaction with HH care (96% satisfied or very satisfied), and their functional capacity improved slightly, as indicated by an increase in the Barthel Index from 74 to 77.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of home hospitalization in the reduction of traditional hospitalization and frequency of emergencies in heart failure]. Bechich, S., Sort Granja, D., Arroyo Mateo, X., et al.[2019]

The implementation of hypertensive disorders of pregnancy (HDP) management pathways in three primary care clinics in Indonesia was found to be acceptable and feasible, with 50 healthcare providers and 61 patients participating in the study.

While providers generally adopted the recommendations for screening and monitoring HDP, challenges such as professional hierarchies and limited resources were identified, suggesting the need for further studies to enhance the pathways' effectiveness in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenging the status quo: results of an acceptability and feasibility study of hypertensive disorders of pregnancy (HDP) management pathways in Indonesian primary care. Ekawati, FM., Emilia, O., Gunn, J., et al.[2023]

A review of 16 international practice guidelines identified key areas for improving the management of hypertensive disorders of pregnancy (HDP) in Indonesian primary care, focusing on clinical management, care planning, and professional communication.

Most guidelines were found to be partially applicable, suggesting that while they can inform practices in Indonesia, further adaptation is necessary to ensure effective implementation in local healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ekawati, FM., Emilia, O., Brennecke, S., et al.[2020]

The MaineHealth Home Diuretic Protocol (HDP) was successfully implemented for managing heart failure patients at home, showing a low readmission rate of only 10% among 60 enrolled patients.

The protocol demonstrated high satisfaction rates, with over 97% of both patients and clinicians reporting positive experiences, indicating its effectiveness and safety in delivering augmented diuretic therapy at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home diuretic protocol for heart failure: partnering with home health to improve outcomes and reduce readmissions. Veilleux, RP., Wight, JN., Cannon, A., et al.[2021]

In a study of 205 pregnant women with hypertensive disorders, those with eclampsia and pre-eclampsia experienced significantly worse perinatal outcomes, including lower Apgar scores and birth weights.

The research highlighted that severe hypertensive conditions, particularly eclampsia and pre-eclampsia, were linked to higher rates of neonatal morbidity and mortality, emphasizing the need for careful monitoring and management in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal Outcome in Women with Hypertensive Disorders of Pregnancy in Rural Tertiary Center of Northern India: A Retrospective Cohort Study". Kumar, N., Yadav, A.[2021]

Citations

1. nature.com nature.com/articles/s44294-025-00095-7

Advances in postpartum hypertension management Effective interventions during this crucial period—including lifestyle changes like a balanced diet, regular physical activity, diligent weight ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05655936?tab=table

Eliminating Severe Maternal Morbidity With Heart Health ... The postpartum Doula will deliver a heart health focused intervention aimed at reducing blood pressure by approximately 12 weeks postpartum. Interventions: ...

3. withpower.com withpower.com/trial/phase-pregnancy-complications-2023-fc0e9

Heart Health Doulas for Hypertensive Disorders of ... In a study of 1,829 women, those with hypertensive disorders in pregnancy (HDP) showed similar levels of physical and psychological health at 3 months ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05655936/eliminating-severe-maternal-morbidity-with-heart-health-doulas-trial

Eliminating Severe Maternal Morbidity With Heart Health ... If assigned to the intervention group, women will attend weekly check-ins with their doula for 8-12 weeks and receive continuous blood pressure ...

5. clinicaltrial.be clinicaltrial.be/fr/details/195033?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Eliminating Severe Maternal Morbidity With Heart Health D... The postpartum Doula will deliver a heart health focused intervention aimed at reducing blood pressure by approximately 12 weeks postpartum.

6. clinconnect.io clinconnect.io/trials/NCT05655936

Eliminating Severe Maternal Morbidity With Heart Health The Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial is a study designed to help women who experience high blood pressure during pregnancy, ...

7. saferbirth.org saferbirth.org/psbs/severe-hypertension-in-pregnancy/

Severe Hypertension In Pregnancy | AIM Develop processes for management of pregnant and postpartum patients with severe hypertension, including: A standard protocol for maternal early warning signs, ...