Gestational diabetes drugs and perinatal outcomes in underserved populations

妊娠糖尿病药物和服务不足人群的围产期结局

• 批准号: 10487395
• 负责人: CARLOS G GRIJALVA
• 金额: $ 25.95万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2024-09-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10487395
• 关键词: Address; Admission activity; Affect; American College of Obstetricians and Gynecologists; Biometry; Birth; Birth Certificates; Birth trauma; Cesarean section; Child Health; Clinical; Clinical Trials; Cohort Studies; Collaborations; Data; Databases; Death Certificates; Diagnosis; Discipline of obstetrics; Dystocia; Ethnic Origin; Face; Fetal Macrosomia; Gestational Age; Gestational Diabetes; Glyburide; Guidelines; Health Policy; Health Services Accessibility; Hospitalization; Hospitals; Hypertension; Hypoglycemia; Hypoglycemic Agents; Infant; Injectable; Injections; Insulin; Intervention; Knowledge; Laceration; Link; Maternal complication; Maternal-fetal medicine; Medicaid; Medication Management; Meta-Analysis; Metformin; Minority; Minority Groups; Minority Women; Modality; Mothers; Neonatal; Neonatal Hypoglycemia; Neonatal Intensive Care Units; Observational Study; Oral; Outcome; Patients; Pharmaceutical Preparations; Pharmacoepidemiology; Pharmacological Treatment; Pharmacology; Population; Postpartum Period; Pregnancy; Pregnancy in Diabetics; Provider; Public Health; Race; Randomized Clinical Trials; Recording of previous events; Records; Registries; Research; Resources; Retrospective cohort study; Risk; Sample Size; Shoulder; Societies; Socioeconomic Status; Testing; Training; Trauma; Underserved Population; United States; Woman; adverse maternal outcomes; adverse outcome; base; black women; clinical practice; clinical trial analysis; clinically relevant; compare effectiveness; computer science; cost; data registry; design; disability; ethnic minority; euglycemia; gaps in access; high risk; improved; interest; low socioeconomic status; maternal hyperglycemia; maternal outcome; multidisciplinary; neonatal outcome; perinatal outcomes; pregnancy disorder; racial and ethnic; racial minority; residence; rural area; rural residence; rurality; sociodemographic disparity; sociodemographic factors; sociodemographics; treatment disparity

PROJECT SUMMARY/ABSTRACT Gestational diabetes mellitus (GDM) is characterized by maternal hyperglycemia leading to fetal overgrowth and associated complications: large for gestational age (LGA), neonatal hypoglycemia, shoulder dystocia, birth injury, and cesarean birth. While insulin has been the traditional pharmacologic intervention to maintain euglycemia among women with GDM, there are numerous barriers to insulin use. Insulin therapy often requires referral to specialized providers, training on administration, and multiple daily injections – all factors that may deter effective utilization, particularly in women from racial/ethnic minorities or living in rural areas. Disparities in diagnosis and treatment of GDM may have large public health implications; non-white women are more than twice as likely to be diagnosed with GDM compared to white women, and black women have higher risks for GDM-associated pregnancy and neonatal complications compared to white women. Newer oral hypoglycemic agents, such as metformin, may be safe and effective alternatives to insulin that are more widely accessible and acceptable in minority or resource-limited populations. The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine continue to disagree about the optimal pharmacological treatment for GDM. Furthermore, to date, few studies have examined how patient sociodemographic factors - especially race/ethnicity, rural residence, and socioeconomic status - impact the relationship between hypoglycemic medication selection and perinatal outcomes. Although the management of GDM ideally would be informed by properly powered randomized clinical trials, the medications of interest are already on the market and new trials are unlikely. Our multidisciplinary team of experts in maternal-fetal medicine, health policy, pharmacoepidemiology, biostatistics, and computer sciences have demonstrated successful collaboration to investigate medication use during pregnancy and the postpartum period. We propose a carefully designed observational cohort study using a comprehensive research platform of linked records including TN Medicaid claims, birth certificates and a registry of all hospital-based encounters in TN, which will focus on relevant clinical outcomes and incorporate the practical complexities of real-world settings. Our proposal aims to test the hypotheses that metformin use in women with GDM is associated with a lower risk of adverse neonatal (Aim 1) and maternal (Aim 2) outcomes compared to glyburide or insulin, especially among women from sociodemographic minority groups. Key neonatal outcomes include large for gestational age, neonatal hypoglycemia, and NICU admission and key maternal outcomes include cesarean birth, new hypertensive disorders of pregnancy, and third- and fourth-degree perineal lacerations.

项目摘要/摘要 妊娠糖尿病（GDM）的特征是母体高血糖导致胎儿过度生长 和相关并发症：胎龄（LGA），新生儿低血糖症，肩部肌张力障碍，较大 出生受伤和剖宫产。胰岛素一直是维持的传统药理干预措施 GDM女性中的尤利克血症，胰岛素使用有许多障碍。胰岛素疗法经常 需要转介给专业提供者，管理培训和多次注射培训 - 所有因素 这可能决定有效利用，特别是在种族/族裔少数民族或农村地区的妇女中。 GDM诊断和治疗的差异可能具有很大的公共卫生影响；非白人妇女 与白人妇女相比，被诊断为GDM的可能性是 与白人女性相比，与GDM相关的妊娠和新生儿并发症的风险更高。较新 口服降血糖剂（例如二甲双胍）可能是胰岛素的安全有效替代品 在少数或资源有限的人群中，更广泛的访问和可接受。美国学院 产科医生和妇科医生以及母亲医学协会继续不同意 GDM的最佳药理治疗。此外，迄今为止，很少有研究研究 社会人口统计学因素 - 尤其是种族/种族，粗糙的居住和社会经济地位 - 影响 降血糖药物选择与围产期结局之间的关系。虽然 理想情况下，GDM的管理将通过适当动力的随机临床试验来告知 感兴趣的药物已经在市场上，新试验不太可能。我们的多学科团队 孕产妇医学，卫生政策，药物ePidemiology，生物统计学和计算机专家 科学表现出成功的合作，以调查怀孕期间的药物使用和 产后期。我们提出了一项精心设计的观察队列研究，使用综合 链接记录的研究平台，包括TN Medicaid索赔，出生证明和所有注册表 田纳西州的基于医院的相遇将重点关注相关的临床结果并纳入 现实环境的实际复杂性。我们的建议旨在检验二甲双胍在 具有GDM的妇女与不良新生儿（AIM 1）和母体（AIM 2）的风险较低有关 与糖或胰岛素相比，结局的结果，尤其是在社会人口统计学的女性中 组。关键的新生儿结果包括胎龄，新生儿低血糖症和NICU 入院和关键的产妇结局包括剖宫产，新的高血压疾病， 以及三度和四度会阴裂缝。