PreeclampsiaHHDNCT05655936
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
A study testing Heart Health Doula Intervention Program in people with Preeclampsia and Hypertensive Disorder of Pregnancy, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Hypertensive Disorder of Pregnancy, Toxemia
- What is being tested?
- Heart Health Doula Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2023to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women must be pregnant or postpartum and assessed during pregnancy and/or delivery with a diagnosis of a hypertensive disorder of pregnancy (pre-eclampsia, eclampsia or gestational hypertension).
- 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
Who cannot join
- No pre-pregnancy chronic conditions that affect blood pressure such as hypertension or on antihypertensive medications within 3 months before conception.
- No diabetes (type 1 or type 2)
- No chronic and severe renal or liver disease or systemic lupus erythematous
- No women under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
The purpose of this study is to improve blood pressure in women who have a hypertensive disorder of pregnancy. A hypertensive disorder of pregnancy is one in which a woman's blood pressure is elevated during pregnancy. For the purpose of this project, a hypertensive disorder of pregnancy includes gestational hypertension, preeclampsia and eclampsia. By improving blood pressure in pregnant women, the investigators aim to lower the number of women with chronic hypertension, cardiovascular disease, and mortality. The study will enroll 454 women who are 18 years or older, are about to or have recently given birth, and have been diagnosed with a hypertensive disorder of pregnancy. Women will be randomly chosen to take part in usual care or an intervention group.
This study is designed to evaluate support for new moms by providing a postpartum doula in partnership with Healthy Start Inc. Healthy Start is a local community-based organization that supports women, children, fathers, families and communities through community-based programming, advocacy, research, and training. The support provided to new moms will include weekly doula sessions (in-person or virtual), education and support, and blood pressure and weight monitoring. Women will be enrolled during their third trimester up until they are a few weeks postpartum and will complete the study around 12 months postpartum. If assigned to the intervention group, women will attend weekly check-ins with their doula for 8-12 weeks and receive continuous blood pressure and weight monitoring throughout the duration of the study. Both groups will be enrolled into a 6-week home-based blood pressure monitoring program with text messaging support (enrollment in the 6-week program is the standard of care at Magee Women's Hospital following a hypertensive disorder of pregnancy). Both the usual care and intervention groups will attend a follow-up visit at 12 months postpartum.
- Conditions
- Preeclampsia, Hypertensive Disorder of Pregnancy, Toxemia, Pregnancy Complications, Hypertension, Pregnancy-Induced, Hypertension
- Being tested
- Heart Health Doula Intervention Program, Usual Care
- Keywords
- Postpartum Doula, Doula Intervention
- Medical subject headings
- Pre-Eclampsia, Toxemia, Pregnancy Complications, Hypertension, Pregnancy-Induced, Hypertension, Obesity, Overweight, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Health Doula Intervention ProgramBehavioural
The intervention group will be given a smart blood pressure cuff and a smart scale to monitor weight. The intervention group will receive support provided a postpartum doula until 8-12 weeks postpartum. The doula will provide individualized support during this time, and after 8-12 weeks, women will transition to a doula-moderated support group for the remainder of the study. The intervention group will continue to receive blood pressure and weight monitoring for the remainder of the study.
Usual CareBehavioural
Usual care includes enrollment into a clinical 6-week home-based blood pressure monitoring program with text messaging support which includes receiving a home blood pressure cuff. Women in the intervention group will be offered the same support as the usual care group, and in addition will receive the intervention and supplies.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | 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. Receives: Behavioral: Usual Care |
| Postpartum Doula Intervention Group | Experimental | 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. Receives: Behavioral: Heart Health Doula Intervention Program; Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess MAP at 12 months postpartum
To test the effectiveness of the postpartum Doula intervention the investigators will evaluate blood pressure and mean arterial pressure (MAP) at 12 months postpartum.
Measured: Baseline to approximately 12 months postpartum
Secondary outcomes (2)
Change from baseline in racial disparities and blood pressure & MAP at 12 months
To determine if an enhanced care strategy reduces racial disparities in blood pressure, the investigators will evaluate blood pressure and mean arterial pressure (MAP) recovery by 12 months postpartum by race and by intervention group. Systolic and diastolic blood pressures will be assessed separately. There is evidence that blood pressure should normalize at 6-12 months postpartum and by assessing black vs white differences, the investigators will determine if the intervention can reduce known disparities in blood pressure and MAP.
Measured: Baseline to approximately 12 months postpartum
Assess Racial Disparities in Healthcare Delivery
Access to optimal clinical care is essential for all women to successfully recover from a hypertensive disorder of pregnancy (HDP) within one year postpartum. The investigators will assess racial differences in healthcare service delivery that contribute to inequities in HDP-related care by reviewing the charts of women who enroll in the study and comparing whether care was received, and the type of care aligned with the guidelines/standards by indicating whether the care met, did not meet, or exceeded the standards at critical time points.
Measured: Up to 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start29 Jun 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will conduct a prospective single site, single-blinded, parallel randomized control trial in which women diagnosed with HDP will be randomized into either the control or intervention group. The investigators will randomize 454 women into usual care, or an 8-12-week heart health intervention program provided by a postpartum Doula. Randomization will be stratified by race to achieve over enrollment of Black and African American participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 454 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Janet Catov, University of Pittsburgh
- Investigators
- Janet Catov, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655936
- Sponsor's protocol ID
- STUDY22060056
- Other IDs
- 1R01MD017083-01A1
- Acronym
- HHD
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data (including data dictionaries) will be shared at the direction of the primary investigator. Data will include blood pressure, weight, demographics, physical activity, and pregnancy related information. Additional documents (such as the study protocol) will be made available. The dataset for our project will be prepared according to requirements for and stored on the Clinicaltrials.gov data repository. Per the NIH guidelines, the dataset will be submitted to the program officer within a year after the outcomes are published and no later than 3 years after the end of clinical activities.