Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615076
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Enhancing Care Outcomes for Patients During the First Postpartum Year
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhancing Care and Outcomes for Patients with Hypertensive Disorders of Pregnancy and Diabetes During the First Postpartum Year a Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans 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 US 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 US rates of maternal deaths and severe maternal morbidity with Black women being 26 times more likely to die than White women The Centers for Disease Control ampamp 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 60 in 2016 to 83 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 womens 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 Marylands 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
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 60 in 2016 to 83 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 womens 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 Marylands 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None