A One-Year Randomized Trial of Metformin Versus Insulin for Glycemic Control and Maternal and Perinatal Outcomes in Gestational Diabetes.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Maternal outcomes like mode of delivery, association with other obstetrical disorders(like gestational hypertension, pre term delivery, etc), conversion to overt DM, etc
研究概览
简要总结
This study aims to compare the effectiveness and safety of Metformin versus insulin in managing gestational diabetes over a year-long randomized clinical trial. Through comprehensive analysis of maternal and perinatal outcomes, the study seeks to address the need for alternative treatments, considering metformin’s potential benefits in glycemic control and cost-effectiveness.
This randomized, open labelled, prospective trial, conducted at KAHER’s Dr. Prabhakar Kore Charitable Hospital and MRC, Belagavi, will involve antenatal cases with gestational diabetes requiring pharmacotherapy, evaluating the efficacy of metformin as a pharmacological intervention.
The study’s methodology includes randomization, regular follow-up assessments, and obstetric management, aiming to contribute valuable insights to gestational diabetes management paradigms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant woman with diagnosed gestational diabetes (according to IADPSG criteria) needing pharmacological intervention/ anti-diabetic drugs.
- •Singleton pregnancy
- •18 to 45 years of age
- •Gestational age of 14 to 35 weeks.
排除标准
- •k/c/o diabetes mellitus
- •Chronic gastrointestinal disease
- •Women with gestational diabetes controlled on diet.
结局指标
主要结局
1. Maternal outcomes like mode of delivery, association with other obstetrical disorders(like gestational hypertension, pre term delivery, etc), conversion to overt DM, etc
时间窗: During pregnancy, at delivery and postpartum.
2. Perinatal outcomes like birth weight, congenital anomalies, neonatal hypoglycemia, Jaundice, respiratory distress, NICU admission, etc
时间窗: During pregnancy, at delivery and postpartum.
次要结局
- Glycemic control(Safety profile)
研究者
Dr Mrunalini Parasharam Patil
Jawaharlal Nehru Medical College