Clinical trial

Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05655936

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionPreeclampsia, Hypertensive Disorder of Pregnancy, Toxemia, Pregnancy Complications, Hypertension, Pregnancy-Induced, Hypertension, Obesity, Overweight, Nutrition Disorders, Vascular Diseases, Cardiovascular Diseases, Pre-Eclampsia, Eclampsia, Gestational Hypertension

Full registry criteria

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

Treatments and study arms

Heart Health Doula Intervention Program

Behavioral

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

Behavioral

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 outcomes

Assess MAP at 12 months postpartumBaseline to approximately 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Magee Women's Hospital of UPMC🇺🇸 Pittsburgh, Pennsylvania, United States

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