Fetal Cerebroplacental Ratio at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy (sensitivity & specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
研究概览
简要总结
The goal of this observational study is to evaluate fetal cerebroplacental ratio at term and its relation to adverse neonatal outcome in patients with gestational diabetes. The main question[s] it aims to answer are:
- To evaluate the efficacy (sensitivity & specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
- To evaluate the difference in fetal cerebroplacental ratio in patients treated by insulin & those on metformin
- to evaluate the incidence of adverse neonatal outcome in patients treated by insulin & those on metformin.
Participants will undergo ultrasound and doppler study at 37 weeks & every two weeks thereafter till delivery. Neonatal assessment will be done after delivery to exclude adverse outcomes.
详细描述
pregnant females in the reproductive age, pregnant ≥37 weeks, who were diagnosed with gestational diabetes by routine screening at 24-28 weeks, and are on metformin or insulin treatment. Informed consent, to share in the study, will be taken from all participants after describing the aim of the study and the potential hazards.
The patients enrolled in our study will be divided into two equal groups according to their treatment regimens:
(Group A): 130 patients who are on insulin treatment
(Group B): 130 patients who are on metformin
*All participants will be subjected to the following:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age: 18-40 years
- •Diagnosed with gestational DM and are on insulin or metformin treatment.
- •Single living pregnancy.
- •Gestational age ≥ 37 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan).
排除标准
- •Fetal anomalies.
- •Maternal chronic diseases esp. renal disease, epilepsy or CNS lesion.
- •Pregnancy induced medical disorders.
- •IUGR (EFW below the 10th percentile for gestational age).
- •Rupture of membranes or oligohydramnios (AFI < the fifth percentile).
结局指标
主要结局
To evaluate the efficacy (sensitivity & specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
时间窗: 17 months
次要结局
- To evaluate the incidence of adverse neonatal outcome in both groups(17 months)
- To evaluate the difference in fetal cerebroplacental ratio in both groups(17 months)
研究者
Mariam Alaaeldin Aly Gabr
Dr.
Cairo University