Clinical trial NCT05430815: Improving Women's Health Through Coordinated Postpartum Planning
Official title: Minding the Gap: Improving Women's Health Through Coordinated Postpartum Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Death
Maternal Morbidity
Keywords: Maternal mortality
Severe maternal morbidity
Postpartum care
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-06-24
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.

Detailed description: The US maternal mortality ratio is the highest among developed nations at 26.4 maternal deaths per 100,000 livebirths. Among the states, Georgia has the second highest maternal mortality (66.3 per 100,000), with a 60% higher rate for black vs white women (95.6 vs 59.7 per 100,000). Nearly 100 times more common than maternal mortality is severe maternal morbidity (SMM), defined as unexpected outcomes of labor and delivery that result in short- and long-term deleterious health consequences. Maternal mortality and SMM are highest among women who are black, publicly insured or uninsured, and deliver in safety-net hospitals. In Georgia, 66% of maternal deaths occur to women insured by Medicaid at delivery and the majority of deaths and SMM occur postpartum, a time during which healthcare visits are poorly attended and oftentimes inaccessible. The Georgia Maternal Mortality Review Committee concluded that two-thirds of maternal deaths are preventable, with chronic health conditions, obesity, delays in accessing and fragmentation of care as key contributors. As solutions, it recommends improved prenatal and postpartum follow-up and case management, control of chronic health conditions, and extension of Medicaid coverage beyond 60 days postpartum.

While the postpartum period represents a crucial window of opportunity for promoting women's current and future health, up to 40% of US women do not attend postpartum visits due to structural barriers (e.g., lack of insurance, transportation or childcare) social barriers (e.g., medical mistrust and poor patient-provider relationships) or low perceived utility of postpartum care. Moreover, the lowest rates of postpartum care utilization are concentrated among women with the highest rates of pregnancy complications and chronic conditions (e.g., women who are uninsured or Medicaid-insured, low-income, and non-Hispanic black). Timely and adequate use of postpartum care is especially important for women with diabetes or hypertensive disease as these conditions are associated with increased risk for postpartum morbidity and mortality and cardiovascular disease later in life.

The researchers of this study plan to conduct an intervention study to assess the effect of a woman-centered, comprehensive postpartum care system on postpartum visit attendance and follow-up care among medically underserved women with chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity or hypertensive disorder of pregnancy (HDP). Because implementing and sustaining a comprehensive postpartum care system in a health disparities population requires a thorough understanding of patient preferences regarding the structural and process elements of care, methods of provider-patient communication, and strategies for addressing social and contextual barriers to care the researchers will use in-depth interviews to inform the intervention design and then assess health outcomes and satisfaction.

Eligibility criteria: Inclusion Criteria:

* pregnant women between 20-34 weeks of gestation
* have received 1 or more prenatal care visits at Grady Memorial Hospital in Atlanta, Georgia (GA)
* intend to deliver at Grady Memorial Hospital
* speak English or Spanish
* have a diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity (body mass index \[BMI\] of 30 or greater), and/or a hypertensive disorder of pregnancy (gestational hypertension or preeclampsia) documented in the electronic medical record (EMR)

Exclusion Criteria:

* adults unable to consent, infants, and prisoners

Primary outcomes:
measure: Number of participants attending the postpartum visit
timeFrame: 12 weeks after delivery
Secondary outcomes:
measure: Number of Participants Receiving Postpartum Diabetes Screening
timeFrame: 12 weeks after delivery
measure: Number of Participants Receiving Postpartum Hypertension Screening
timeFrame: 12 weeks after delivery
measure: Number of Participants Using Contraception
timeFrame: 12 weeks after delivery, 14 months after delivery
measure: Number of Participants Using Medication
timeFrame: 12 weeks after delivery, 14 months after delivery
measure: Number of Participants with Ongoing Pregnancy Complications
timeFrame: 12 weeks after delivery, 14 months after delivery
measure: Number of Participants Readmitted to the Hospital
timeFrame: 12 weeks after delivery, 14 months after delivery
measure: Perceived Risk of Severe Maternal Morbidity (SMM)
timeFrame: 12 weeks after delivery
measure: Perceived Risk of Cardiovascular Disease
timeFrame: 12 weeks after delivery, 14 months after delivery
measure: Number of Participants Using Primary Care
timeFrame: 12 weeks after delivery, 14 months after delivery
measure: Number of Participants Using Specialty Care
timeFrame: 12 weeks after delivery, 14 months after delivery
measure: Edinburgh Postnatal Depression Scale (EPDS) Score
timeFrame: 12 weeks after delivery, 14 months after delivery
measure: Satisfaction with Postpartum Care
timeFrame: 12 weeks after delivery
measure: Satisfaction with Provider at Postpartum Care Visit
timeFrame: 12 weeks after delivery
measure: Self-rated Health
timeFrame: 14 months after delivery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Anne Dunlop, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: