Adverse Pregnancy Outcomes, Preeclampsia Postpartum
Conditions
Keywords
community health workers, adverse pregnancy outcomes, preeclampsia
Brief summary
United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE) and other adverse pregnancy outcomes (APOs). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.
Detailed description
The investigators will adapt a current perinatal community health worker intervention, lead by a leading community health worker organization, Connection Health, to the unique needs of Black postpartum patients with preeclampsia and other adverse pregnancy outcomes. The investigators will conduct a pilot trial to assess the feasibility and acceptability of the intervention. The hypothesis is that it is possible to randomize eligible patients to the feasibility trial, and the intervention will be acceptable to participants. The investigators will randomize Black postpartum patients with preeclampsia or other adverse pregnancy outcomes to either 1) usual care - cardiovascular disease-prevention education before discharge, or 2) intervention - cardiovascular disease prevention education before discharge plus an adapted Connection Health community health worker intervention. Following the completion of this project, the investigators intend to conduct a larger postpartum community health worker intervention trial in patients with preeclampsia or other adverse pregnancy outcomes powered to detect a difference in clinically meaningful outcomes, as informed by our existing community advisory board.
Interventions
BEHAVIORALusual postpartum care
Usual clinical and educational postpartum care
BEHAVIORALusual postpartum care + community health worker intervention
participants will receive routine care and also community health worker support and visits.
Sponsors
University of Alabama at Birmingham
American Heart Association
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 56 Years
Healthy volunteers
Yes
Inclusion criteria
* Self Identifies as Black * Between 16-56 years old * Experiencing adverse pregnancy outcomes defined as hypertensive disorders of pregnancy, preterm birth, placental abruption, pregnancy loss (loss at greater or equal to 14 weeks gestation), gestational diabetes, delivering a small for gestational age infant * Planning to deliver at UAB Hospital * Speaks and writes in English
Exclusion criteria
* Declines Randomization * Speaks or writes in languages other than English * Currently incarcerated * Previously enrolled in P3OPPY
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With Postpartum Support | Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum. | Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10). Participant satisfaction with postpartum support received as part of the study, measured on a 1 to 10 scale where 1 = lowest satisfaction and 10 = highest satisfaction. Higher scores represent greater satisfaction (a better outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With CHW Intervention | Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum. | Patient satisfaction with CHW intervention using Sekhon Questionnaire to Assess the Acceptability of Healthcare Interventions, 1-5 scale with 1 being the lowest acceptability to 5 being the highest acceptability. |
| Primary Care Visit Scheduled | Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum. | Participant reports at least one visit is scheduled with a primary care provider |
| Mean Blood Pressure | Measured at the in-person postpartum clinic visit, occurring anytime between 6 and 12 weeks postpartum. | Mean systolic and diastolic blood pressure measured clinically at the in-person postpartum clinic visit occurring between 6 and 12 weeks postpartum. Reported as mean (standard deviation) in mmHg. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJesse E Rattan
University of Alabama at Birmingham
Participant flow
Recruitment details
Participants were recruited during their delivery-associated hospitalization at a single tertiary care institution in Alabama. Eligible individuals were approached after experiencing an adverse pregnancy outcome, identified as Black or African American, spoke English, and delivered at ≥14 weeks gestation. Recruitment occurred from September 2024 to June 2025. Of 95 individuals assessed for eligibility, 61 (64%) consented and were randomized.
Pre-assignment details
There were no significant events between enrollment and randomization. Participants were consented and randomized during their delivery-associated hospitalization. All 61 enrolled participants were randomized ; no participants were lost or withdrawn between enrollment and assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 6.4 |
| APO type Gestational diabetes | 3 Participants |
| APO type Gestational hypertension | 9 Participants |
| APO type Preeclampsia | 17 Participants |
| APO type Small for gestational age infant | 5 Participants |
| BMI at enrollment | 39.6 kg/m squared |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Insurance type (Gov't/Medicaid vs. Private) Gov't/Medicaid | 20 Participants |
| Insurance type (Gov't/Medicaid vs. Private) Private | 22 Participants |
| Parity (multiparous yes/no) Multiparous | 37 Participants |
| Parity (multiparous yes/no) Nulliparous | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 61 Participants |
| Sex/Gender, Customized Female | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
None listed