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

Trial Summary

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. ^{1 2 3 4 5}

How 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. ^{6 7 8 9 10}

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.

Research Team

Janet Catov, PhD

Principal Investigator

University of Pittsburgh

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Postnatal health and care following hypertensive disorders in pregnancy: a prospective cohort study (BPiPP study). [2022]

2. England 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. [2023]

3. Scotland 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. [2021]

4. Netherlands 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. [2020]

5. United Arab Emirates 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". [2021]

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

Educational level and self-care behaviour in patients with heart failure before and after nurse educational intervention. [2015]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Heart Failure Caregiver Self-Care: A Latent Class Analysis. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

[Effect of home hospitalization in the reduction of traditional hospitalization and frequency of emergencies in heart failure]. [2019]

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

Home diuretic protocol for heart failure: partnering with home health to improve outcomes and reduce readmissions. [2021]