University of Alabama at Birmingham (UAB Women and Infants Center)
Birmingham, Alabama, 35233, United States
NCT Number: NCT07778966
High blood pressure during or after pregnancy (such as preeclampsia, gestational hypertension, eclampsia, or HELLP syndrome) raises a mother's risk of heart disease later in life. Many patients do not return for follow-up care after delivery, missing a key window to protect their heart health. The Alabama Womb to Heart Solution (AW2H) trial will test whether pairing postpartum patients with a trained community health worker (CHW) for 6 months lowers blood pressure compared with usual care.
A total of 174 postpartum patients who had pregnancy-associated hypertension or stage 2 high blood pressure will be randomly assigned (1:1) to usual care or usual care plus the AW2H CHW program. All participants receive education on measuring their own blood pressure and a pregnancy-validated home blood pressure monitor. Participants in the CHW group are also contacted regularly by a CHW for 6 months. CHWs coach home blood pressure monitoring, support taking blood pressure medications as prescribed, encourage heart-healthy habits based on the American Heart Association's Life's Essential 8, help schedule a primary care visit, provide mother-baby education (such as safe sleep and immunizations), and offer emotional support.
The main outcome is systolic blood pressure 6 months after enrollment, measured at home with the study-provided monitor while a research coordinator observes in person or by video/phone. The study will also look at diastolic blood pressure and whether participants scheduled a primary care visit. Interviews and focus groups will explore participant, CHW, and provider experiences with the program.
Trial opening soon.
Get Notified16 year–56 year
Female
Interventional
Not applicable
Birmingham, Alabama, 35233, United States
This is a single-site, two-arm, parallel, randomized controlled efficacy trial conducted at the University of Alabama at Birmingham (UAB), building on the AW2H feasibility/acceptability pilot (NCT06353256, N=61). Postpartum patients with pregnancy-associated hypertension (gestational hypertension, preeclampsia, eclampsia, hypertension with superimposed preeclampsia, or HELLP syndrome) or stage 2 hypertension (SBP >=140 mmHg or DBP >=90 mmHg) are randomized 1:1 to usual care or usual care plus a 6-month CHW intervention delivered in partnership with ConnectionHealth.
Usual care (both arms) includes brief self-measured blood pressure education, a pregnancy-validated iHealth BP Cuff Kit (provided through partnership with the Preeclampsia Foundation), and written education on hypertensive disorders of pregnancy and long-term cardiovascular risk. The CHW intervention adds visits or contacts approximately 2 times per week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26 (in person or virtual), covering home BP monitoring coaching with ACOG-concordant escalation guidance, medication adherence, postpartum and pediatric visit reminders, breastfeeding and contraception counseling, Life's Essential 8 behavior coaching, primary care linkage, mother-baby education, and trauma-informed emotional support.
The primary outcome is mean systolic blood pressure at 6 months post-enrollment (mean of 3 readings taken 1 minute apart with the validated iHealth monitor, following a protocol adapted from the CHAP Maternal Follow-up Study). The trial provides 80% power to detect a 7 mmHg difference in SBP (SD 14.5, two-sided alpha=0.05) with 138 participants; enrollment of 174 allows for 20% attrition. Analysis follows intent-to-treat principles. Aim 2 comprises qualitative interviews (up to 20 intervention-arm participants) and two focus groups (CHWs/ConnectionHealth leadership; healthcare providers) analyzed thematically to inform future implementation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Six-month CHW program delivered in partnership with ConnectionHealth. Visit/contact frequency: Approximately 2 times/week for weeks 1-5, weekly for weeks 6-12, and monthly for weeks 13-26; visits may be in person or virtual (phone/video). CHWs coach home blood pressure monitoring with ACOG-concordant escalation guidance, reinforce antihypertensive medication adherence, educate on postpartum danger signs and long-term cardiovascular risk, remind about postpartum and pediatric visits, counsel on breastfeeding and contraception, coach on AHA Life's Essential 8 behaviors, assist with scheduling and attending a primary care appointment, provide mother-baby guidance (safe sleep, immunizations, developmental milestones), and offer trauma-informed emotional support.
Standardized self-measured blood pressure (SMBP) education and a pregnancy-validated iHealth BP Cuff Kit provided before hospital discharge, plus written educational materials on hypertensive disorders of pregnancy and other adverse pregnancy outcomes, long-term CVD risk, and postpartum danger signs.
Time frame: 6 months post-enrollment
Mean systolic blood pressure in mmHg, calculated as the mean of 3 readings taken 1 minute apart using a pregnancy-validated iHealth home blood pressure monitor, following a standardized measurement protocol during an in-person or coordinator-observed virtual visit.
Time frame: 6 months post-enrollment
Mean diastolic blood pressure in mmHg, calculated as the mean of 3 readings taken 1 minute apart using the same standardized protocol as the primary outcome.
Time frame: By 6 months post-enrollment
Proportion of participants with integration into primary care, defined as participant self-report of a scheduled primary care visit.
Time frame: 6 months post-enrollment
Mean arterial blood pressure in mmHg, derived from blood pressure readings taken using the same standardized protocol as the primary outcome.
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
Alabama Womb to Heart Solution: A Community-Based Cardiovascular Health Intervention After Hypertension in Pregnancy
Acronym: AW2H
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