A one year prospective cohort study of screening for diabetes mellitus among postpartum women with gestational diabetes mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To screen for diabetes mellitus among postpartum women with gestational diabetes mellitus
研究概览
简要总结
Introduction and Need for the study
Gestational Diabetes Mellitus (GDM) is a common pregnancy-related metabolic disorder, affecting around 3.5% of pregnant women in Karnataka. It significantly increases the risk of adverse maternal and neonatal outcomes, including preeclampsia, macrosomia, and neonatal hypoglycemia. Women with GDM have up to a 6.35-fold higher risk of developing Type 2 Diabetes Mellitus later in life. GDM is also linked to long-term complications such as metabolic syndrome and cardiovascular disease. However, postpartum screening for glucose intolerance remains inadequate due to systemic and patient-related challenges.
Despite guideline recommendations for postpartum screening between 4–12 weeks, adherence remains low in India due to cultural, economic, and logistical barriers. Many women miss follow-up visits, limiting early detection of persistent glucose intolerance and T2DM. Current research lacks data on how breastfeeding, physical activity, and psychosocial health influence glycemic outcomes. There’s also limited representation from rural and diverse socioeconomic groups. This study aims to address these gaps and inform targeted strategies for postpartum diabetes prevention.
Data collection procedure
Informed consent will be taken after screening for eligibility.
In total, enrolled study participants between 2 to 5 days after delivery fasting blood sample of 2ml venous blood is taken, and between 4 to 12 weeks postpartum, are instructed to fast for at least 8 hours before the test. A fasting blood sample of 2 mL venous blood is taken under aseptic conditions, and after that, 75 grams of glucose dissolved in water must be consumed within 5 minutes.
After the glucose drink, blood samples are collected at specific intervals to measure the response of the body to the glucose.
The intervals include 1 hour after drinking the glucose solution and 2 hours after drinking the glucose solution.
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 with Gestational diabetes mellitus confirmed by the Diabetes In Pregnancy Study Group India /International Association of Diabetes in Pregnancy Study Group Women delivered at KLE Dr. Prabhakar Kore Hospital.
排除标准
- •Overt diabetes mellitus patients Pregnant women declined to participate.
结局指标
主要结局
To screen for diabetes mellitus among postpartum women with gestational diabetes mellitus
时间窗: 4 to 12 weeks postpartum
次要结局
- To find out the barriers to postpartum screening for diabetes mellitus in gestational diabetes mellitus patients(4 weeks to 12 weeks postpartum)
研究者
Guntaka Tejaswi Reddy
Jawaharlal Nehru Medical College, Belagavi