Role of HbA1c in Predicting Adverse Pregnancy Outcomes Among Gestational Diabetes Mellitus Women: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- To determine the HbA1c reference value in predicting adverse pregnancy outcomes
研究概览
简要总结
This study aims to determine the reference value of HbA1c that can be used to predict adverse pregnancy outcomes. These adverse outcomes include LGA fetus, shoulder dystocia, caesarean section, pre-term birth, pre-eclampsia and fetal neonatal hypoglycaemia.
详细描述
This study involves the data in our centre concerning women with gestational diabetes mellitus. The diagnosis of gestational diabetes mellitus is based on NICE guideline whereby the fasting glucose is 5.6 mol/l or more and 2 hours post glucose load 7.8 mol/l or more. The results of HbA1c and fructosamine taken during the antenatal care are documented. Outcomes of the pregnancy are documented such as antenatal complications, mode of delivery, gestational age at delivery, intrapartum and postpartum complications and neonatal complications. The results of this study is hoped to provide information on the optimum targeted levels of HbA1c and fructosamine for patients with gestational diabetes mellitus. This is the gap in knowledge in managing this cohort of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman with singleton pregnancy
- •Confirmed diagnosis of GDM based on Malaysia CPG (≥5.1/7.8)
- •HbA1c level taken at least once at any time during the pregnancy
- •Delivery after 28 weeks gestation
排除标准
- •Major fetal anomaly
- •Haemoglobin level of ≤9 g/dL (moderate or severe anaemia in pregnancy)
- •Women with autoimmune diseases
- •Overt diabetes or pre-existing diabetes
结局指标
主要结局
To determine the HbA1c reference value in predicting adverse pregnancy outcomes
时间窗: Throughout study up to 1 year
c) To determine the HbA1c value to be used at each trimester in predicting adverse pregnancy outcomes
次要结局
- To determine the prevalence of adverse pregnancy outcomes among women with GDM(Throughout study up to 1 year)
- To assess the HbA1c value during the diagnosis of GDM and its association with adverse pregnancy outcomes(Throughout study up to 1 year)
研究者
Rahana Abd Rahman
Assoc Prof Dr
National University of Malaysia