Clinical trial NCT06615076: Enhancing Care & Outcomes for Patients During the First Postpartum Year
Official title: Enhancing Care and Outcomes for Patients with Hypertensive Disorders of Pregnancy and Diabetes During the First Postpartum Year: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Period
Pregnancy
Hypertension, Pregnancy Induced
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The United States is in the midst of a maternal mortality and morbidity crisis, with more than half of maternal deaths occurring within the first postpartum year. Patients with hypertensive disorders of pregnancy (HDP) and diabetes have been found to be particularly high-risk, as they have a significantly increased risk for the development of cardiovascular disease in the long-term postpartum period. Traditionally, postpartum care has consisted of a single office visit at six weeks postpartum. Recent research has suggested that postpartum care should be an ongoing process, tailored to each woman's specifics needs. The purpose of this research study is to evaluate the effectiveness of obstetric care providers as primary care providers for patients at increased risk of maternal morbidity and mortality in the full first postpartum year.

Detailed description: Maternal mortality rates (MMR) and rates of pregnancy-related deaths continue to worsen in the United States (U.S.), with more women dying per capita as a result of complications from pregnancy and childbirth than in any other high-income nation. Persistent and stark racial disparities exist in U.S. rates of maternal deaths and severe maternal morbidity, with Black women being 2.6 times more likely to die than White women. The Centers for Disease Control \&amp;amp; Prevention (CDC) estimate that 69% of pregnancy-related deaths occur within the postpartum period, with 36% occurring up to one week after delivery and 33% occurring up to one year after delivery. It is estimated that 60% of maternal deaths are preventable. This fact, along with the rise in postpartum maternal mortality suggests there are unmet medical needs during this time interval.

Hypertensive disorders in pregnancy (HDP), defined as pre-pregnancy (chronic) or pregnancy-associated hypertension, are the most common complication observed during pregnancy, affecting 8%-10% of all pregnancies in the United States. HDP continue to be among the leading causes of pregnancy-related maternal mortality worldwide and contribute to 7% of pregnancy-related maternal deaths in the United States annually. Additionally, the rates of HDP align with the racial disparities seen in maternal morbidity and mortality, with Black and American Indian and Alaska Native women being affected two to three times more than non-Hispanic White women. Despite being a leading cause of severe maternal morbidity and mortality during pregnancy and in the postpartum period, HDPs are preventable. Close monitoring of BP and timely intervention are essential for reducing morbidity in women with HDP, especially preeclampsia, due to the progressive nature of the disease. The American College of Obstetricians and Gynecologists (ACOG) recommends BP monitoring throughout pregnancy, as well as at 72-hour postpartum and again between 7-10 days postpartum.

The prevalence of gestational diabetes, which is the onset of glucose intolerance within pregnancy, has steadily risen in the United States, increasing from 6.0% in 2016 to 8.3% in 2021. Gestational diabetes has become an indicator of future cardiovascular disease and an established threat of maternal morbidity and mortality. Accordingly, the American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) stress the importance of screening women with a prior diagnosis of gestational diabetes for continued glucose intolerance at six weeks postpartum and at least once every 3 years after pregnancy.

ACOG states that the weeks following birth are a critical period for a woman and her infant, setting the stage for long-term health outcomes and well-being. ACOG recommends postpartum care should be an ongoing process rather than a single encounter to optimize the health of women and infants. Postpartum follow-up beyond the traditional 6-week visit is particularly important for women with medical complications during pregnancy. Lack of insurance and lack of primary care provider have been cited as obstacles to this follow-up in low-income individuals. Research suggests that obstetric care providers can be effective PCPs and that many patients of reproductive age consider and prefer their obstetric or gynecologic care provider to be their PCP and may not visit another PCP regularly.

The Maryland legislature recently passed Senate Bill 923 which requires Medicaid to extend postpartum coverage for eligible pregnant women from 2 months to 12 months immediately following the end of the women's pregnancy. Postpartum coverage changes began April 1, 2022. Maryland is nationally on the forefront of this initiative, with few other states having enacted this legislation previously. The University of Maryland Medical System is uniquely poised and obligated, as Maryland's state hospital and hospital network, to enact proactive workflows and interventions to take advantage of this Medicaid expansion to improve patient care and outcomes for patients who develop hypertensive disorders of pregnancy during the first year postpartum. Patients of color and patients who receive Medicaid are disproportionately at risk for HDP and diabetes, are a large part of the systems patient population, and could benefit from increased longitudinal care with their OB providers.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Pregnant individuals
* Planning to deliver and continue postpartum care at the University of Maryland Medical Center
* Diagnosis of HDP or diabetes (pre-gestational or gestational) before discharge from admission for delivery
* Medicaid insurance coverage

Exclusion Criteria:

* Less than 18 years of age
* Fetal demise
* No diagnosis of HDP and/or diabetes (pre-gestational or gestational)
* Non-Medicaid insurance coverage

Primary outcomes:
measure: Change in systolic blood pressure measurement from baseline
timeFrame: 6 weeks, 3, 6, and 12 months postpartum
measure: Change in diastolic blood pressure measurement form baseline
timeFrame: 6 weeks, 3, 6, and 12 months postpartum
measure: Change from baseline in blood glucose level measured by fingerstick
timeFrame: 6 weeks, 3, 6, and 12 months postpartum
measure: Change in serum A1C level from baseline
timeFrame: 6 and 12 months postpartum
Secondary outcomes:
measure: Postpartum depression severity assessed using Edinburgh Depression Scale (EPDS)
timeFrame: 6 weeks and 3, 6, and 12 months postpartum
measure: Postpartum anxiety severity assessed using Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: 6 weeks and 3, 6, and 12 months postpartum
measure: Change in weight measured by change in kilograms from baseline
timeFrame: 3, 6, and 12 months postpartum
measure: Maternal satisfaction with postpartum care assessed through surveys/interviews
timeFrame: 3, 6, and 12 months postpartum
measure: Identification of a primary care provider elicited through interviews
timeFrame: 3, 6, and 12 months postpartum
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Jenifer Fahey, CNM, PhD
role: PRINCIPAL_INVESTIGATOR
References: