Diabetes in Pregnancy, Therapy and Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- APGAR Score
研究概览
简要总结
To compare the clinical, glycemic profile and therapy as well as pregnancy complications and infant mortality among diabetic mothers in Indonesia.
详细描述
Pregnancy is a diabetogenic state with increasing burden on the mother's metabolism. Insulin resistance is often found during pregnancy leading to a compensatory increase in pancreatic β-cell response and eventually hyperinsulinemia. Undiagnosed and untreated diabetes in pregnancy have been shown to be linked with numerous comorbidities and complications to both mother and foetus.
This study aims to compare the clinical, glycemic profile along with comorbidities, management and outcomes of diabetic mothers. Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24 were included in this study. The inclusion criteria was all patients with primary diagnosis of O24, have visited the clinic at least twice with a complete record of glycemic profile, management and fetal outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinical and laboratory diagnosis of Diabetes in Pregnancy (Gestational and Pregestational diabetes)
- •Mothers must have visited the clinic at least twice throughout their pregnancy, at least one at the first trimester and one at the third trimester
排除标准
- •Pregnancy is still undergoing
- •Incomplete record of glycemic profile, management and fetal outcomes
研究组 & 干预措施
Good Outcome
Good outcome is defined as the safe delivery of the newborn.
干预措施: Medical Nutrition Therapy (Dietary Supplement)
Good Outcome
Good outcome is defined as the safe delivery of the newborn.
干预措施: Insulin (Drug)
Good Outcome
Good outcome is defined as the safe delivery of the newborn.
干预措施: Oral Antidiabetics (Drug)
Poor Outcome
Poor outcome is defined as the incidence of fetal demise during pregnancy.
干预措施: Medical Nutrition Therapy (Dietary Supplement)
Poor Outcome
Poor outcome is defined as the incidence of fetal demise during pregnancy.
干预措施: Insulin (Drug)
Poor Outcome
Poor outcome is defined as the incidence of fetal demise during pregnancy.
干预措施: Oral Antidiabetics (Drug)
结局指标
主要结局
APGAR Score
时间窗: At time of delivery
One and five minute APGAR Scores as recorded in medical records
Infant Mortality
时间窗: Throughout the length of pregnancy, an average of 9 months
Infant Mortality either due to abortion, intrauterine fetal death or stillbirth as recorded in medical records
Infant Head Circumference
时间窗: At time of delivery
Infant Head Circumference as recorded in medical records
Gestational Age at Birth
时间窗: At time of delivery
Infant Gestational at Birth as recorded in medical records
Infant Body Weight
时间窗: At time of delivery
Infant Body Weight as recorded in medical records
Infant Body Length
时间窗: At time of delivery
Infant Body Length as recorded in medical records
次要结局
- Maternal Mortality(Throughout the length of pregnancy, an average of 9 months)
- Comorbidities(Throughout the length of pregnancy, an average of 9 months)
- Method of Delivery(At time of delivery)
研究者
Anthony Paulo Sunjaya
Principle Investigator
Tarumanagara University