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.

项目总结/摘要 妊娠期糖尿病（GDM）的特征是母体高血糖导致胎儿过度生长 及相关并发症：大于胎龄儿（LGA）、新生儿低血糖、肩难产， 产伤和剖腹产虽然胰岛素一直是传统的药物干预，以维持 在GDM女性中，胰岛素使用存在许多障碍。胰岛素治疗通常 需要转介到专业提供者，管理培训和每日多次注射-所有因素 这可能阻碍有效利用，特别是少数种族/族裔妇女或生活在农村地区的妇女。 GDM诊断和治疗的差异可能对公共卫生产生重大影响;非白人妇女 被诊断为GDM的可能性是白色女性的两倍多，黑人女性 与白色女性相比，GDM相关妊娠和新生儿并发症的风险更高。较新 口服降糖药，如二甲双胍，可能是安全有效的胰岛素替代品， 在少数民族或资源有限的人群中更广泛地获得和接受。The American College of 妇产科医生和母胎医学协会仍然不同意 GDM的最佳药物治疗。此外，到目前为止，很少有研究探讨患者如何 社会人口因素-特别是种族/民族，农村居住和社会经济地位-影响 降糖药物选择与围产期结局的关系虽然 理想情况下，GDM的管理将通过适当的随机临床试验获得信息， 感兴趣的药物已经上市，新的试验不太可能。我们的多学科团队 母胎医学、卫生政策、药物流行病学、生物统计学和计算机专家 科学界已经证明了成功的合作，以调查怀孕期间的药物使用， 产后时期。我们提出了一个精心设计的观察性队列研究，使用一个全面的 链接记录的研究平台，包括TN Medicaid索赔，出生证明和所有登记 在TN的医院为基础的遭遇，这将侧重于相关的临床结果，并纳入 现实世界的复杂性。我们的建议旨在验证二甲双胍用于 GDM妇女与新生儿（目标1）和母体（目标2）不良风险较低相关 与格列本脲或胰岛素相比的结局，特别是在社会人口学少数群体的女性中 组关键的新生儿结局包括大于胎龄儿、新生儿低血糖和NICU 入院和关键的产妇结局包括剖腹产，新发妊娠高血压疾病， 以及三度和四度会阴撕裂伤