Improving postpartum health for women with high blood pressure during pregnancy
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
This study tests whether extra support and monitoring after childbirth can help women with high blood pressure during pregnancy stay healthier and lower their risk of heart problems later on.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 454 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05655936 on ClinicalTrials.gov |
What this trial studies
This trial investigates a multi-level intervention aimed at improving postpartum blood pressure in women diagnosed with hypertensive disorders of pregnancy. Participants will be randomly assigned to receive either usual care or an enhanced intervention that includes home blood pressure monitoring and support from a trained heart health doula. The study will enroll women during their third trimester up to two weeks postpartum and will assess their health outcomes over a 12-month period. The intervention aims to provide education, support, and monitoring to reduce the risk of chronic hypertension and cardiovascular disease.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are pregnant or recently postpartum with a diagnosis of a hypertensive disorder of pregnancy.
Not a fit: Patients with pre-existing chronic conditions affecting blood pressure or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve postpartum health outcomes for women with hypertensive disorders, potentially reducing long-term health risks.
How similar studies have performed: Other studies have shown promise in using doula support for maternal health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- Magee Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Janet Catov, PhD — University of Pittsburgh
- Study coordinator: Janet Catov, PhD
- Email: catovjm@mwri.magee.edu
- Phone: 412-641-6217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.