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Heart Health Doulas

Sponsor:

University of Pittsburgh

Code:

NCT05655936

Conditions

Preeclampsia

Hypertensive Disorder of Pregnancy

Toxemia

Pregnancy Complications

Hypertension, Pregnancy-Induced

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Heart Health Doula Intervention Program

Usual Care

Study Details

Brief 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. 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.

Conditions

Preeclampsia

Hypertensive Disorder of Pregnancy

Toxemia

Pregnancy Complications

Hypertension, Pregnancy-Induced

Study ID

NCT05655936

Start date

Jun 29, 2023

Status verified date

Jun, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion

  • 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

Exclusion

  • 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

Study Design

Enrollment

454 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Usual Care Group

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.

experimental: Postpartum Doula Intervention Group

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.

Interventions

Heart Health Doula Intervention Program

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 Care

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.

Primary outcome measure

  • Assess MAP at 12 months postpartum [ Time Frame: Baseline to approximately 12 months postpartum ]

Central Contacts and Locations

More Information

Sponsor

University of Pittsburgh

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Postpartum Doula, Doula Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-06-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.