The Role of Umbilical Cord Thickness, Interventricular Septum Thickness and HbA1C Levels in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)
研究概览
简要总结
The aim of this work is the prediction of fetal macrosomia by measuring:
- HbA1C.
- Umbilical cord thickness.
- Interventricular septum thickness.
详细描述
This prospective case control study will be carried out at Ain shams university maternity hospital between April 2015 and October 2015 on 80 patients. The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee. A verbal consent will be taken from each patient.
The following investigation will be performed:
- Calculation of gestational age will be based on the last reliable menstrual period or ultrasound examination within the first trimester.
The ultrasound examination will be with Voluson E6 equipped with a 3.5 Hz trans-abdominal probe at fetal medicine unit of maternity hospital Ain Shams University. 2. Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.
During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock's formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton gestation.
- •Gestational age over 27 weeks.
- •Intact membranes.
- •Normal umbilical morphology (two arteries and one vein).
- •Diagnosis of gestational diabetes.
排除标准
- •The presence of fetal congenital anomalies.
- •Multifetal pregnancy.
- •Maternal chronic diseases (hypertension, renal disease, cardiac and pulmonary disease, etc.).
- •Patients with a diagnosis such as oligohydramnios , pre-eclampsia and intrauterine growth retardation.
- •Patients who used cigarettes or alcohol during pregnancy.
结局指标
主要结局
The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)
时间窗: at birth
The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.
次要结局
- Umbilical Cordcross-sectional Area(36-37 weeks of gestation)
- Interventricular Septum Thickness(36-37 weeks of gestation)
- Prediction of Fetal Macrosomia by Measuring HbA1C in Participants(36-37 weeks of gestation)
研究者
Rehab Mohamed Abdelrahman
Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University
Ain Shams University