Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women a Randomized Control Trial.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Neonatal birth weight
研究概览
简要总结
To evaluate the role of metformin in pregnant women with obesity (BMI above 30) , on maternal and infant outcome.
详细描述
Obesity is defined as having an excessive amount of body fat based on the BMI, Obesity can be classified based on the BMI to obese class I ,Class II ,and extreme obesity (class III) , Obesity can harm the fertility by inhibiting normal ovulation. Even in women who regularly ovulate, the greater the BMI, the longer it appears to take to become pregnant. Obesity can also affect the outcome of in vitro fertilization (IVF). (1)
Being obese during pregnancy increases the risk of various pregnancy complications, including :
Miscarriage ,stillbirth ,GD , preeclampsia , obstructive sleep apnea , difficult vaginal delivery ,need for C-section ,and complication of C-section ,Fetal macrosomia , and increasing the risk for metabolic syndrome and childhood obesity , it also make It may be hard for the participants health care provider to diagnose birth defects during pregnancy even prenatal tests like ultrasound(2),(3) .
Normal weight gain during pregnancy for obese women having single pregnancy is between about (5-9) KG .
Normal weight gain during pregnancy for obese women having Multiple pregnancy is between about (11-19) KG (4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 44 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with BMI ≥ 30 kg/m2, and normal glucose tolerance test.
排除标准
- •pregnant women who are diabetic,
- •had a history of previous GDM,
- •previous small baby,
- •previous early pre-eclampsia,
研究组 & 干预措施
group A
obese pregnant women who take metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Neonatal birth weight
时间窗: Baseline
The fetus is regarded as suspected appropriate for gestational age (AGA) when the Sonographic Estimated Fetal Weight (SEFW) is at 10th to 90th percentile for gestational age (GA), and suspected LGA when the SEFW \> 90th percentile ,A baby diagnosed with fetal macrosomia has a birth weight of more than 8 pounds,(4,000 grams), regardless of his or her gestational age.
次要结局
- Maternal weight gain(Baseline)
研究者
Andrew Ibram Samy
principal investigator
Assiut University