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临床试验/CTRI/2024/10/074938
CTRI/2024/10/074938尚未招募不适用

Prescription pattern analysis of antidiabetes therapy in gestational diabetes patients

未提供1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
138
试验地点
1
主要终点
Evaluating the change in blood glucose levels when treated with different antidiabetic medications

研究概览

简要总结

Eligible patients will be selected based on inclusion and exclusion criteria, and their data will be gathered through patient profile forms, treatment charts, and prescriptions. This includes information on the types and patterns of antidiabetic medications prescribed, frequency of dose changes, and reasons for adjustments. Incidence and details of hypoglycemic episodes will be recorded from patient self-reports and progress records. Maternal and fetal outcomes, such as weight gain, blood pressure, incidence of preeclampsia, birth weight, and gestational age at delivery, will be documented. Additionally, the cost of illness will be analyzed by collecting direct medical costs (medications, diagnostic tests, hospital visits), direct non-medical costs (transportation, medical supplies), and indirect costs (loss of income, caregiver support) from billing records, insurance claims, and patient surveys. Data will be collected at baseline, during each prenatal visit, and at the first postpartum visit to ensure comprehensive tracking of clinical outcomes and treatment costs.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Women diagnosed with gestational diabetes.
  • Prescribed with any form of antidiabetic therapy (insulin and oral hypoglycemics) during pregnancy, and eligible for a switch to other antidiabetic medications based on predefined criteria for blood glucose control.
  • Participants at any stage of gestation during diagnosis.
  • Participants who provide informed consent to participate in the study.

排除标准

  • Preexisting type-1 and type-2 diabetes and used any antihyperglycemic medications prior to their diagnosis of GDM.

结局指标

主要结局

Evaluating the change in blood glucose levels when treated with different antidiabetic medications

时间窗: at baseline, 4 weeks and 8 weeks

次要结局

  • Observing HbA1c levels, frequency of hypoglycemia & the maternal & fetal outcomes.(The risk developed due to the antidiabetic treatment in gestational diabetic patients.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Sushma R

manipal college of pharmaceutical sciences

研究点 (1)

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