Effect of Adding Metformin to Insulin Therapy in Pregnant Women With Type I Diabetes as Regards Pregnancy Outcome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study group and control group, to compare the usage of both metformin and insulin instead of using insulin alone. Group assignment will be randomized by computer program.
详细描述
A total of 80 uncontrolled diabetic pregnant patients in the 3rd trimester seeking medical advice in Beni-Suef University Hospital and meet the eligibility criteria, are approached about participation in the trial and given information pamphlets describing the study. The patients are asked to sign a consent form and will be assigned to one of the 2 groups: Group A (study group); will include 40 patients who will be treated with metformin
(1 gm twice daily (with the 2 main meals)), combined with insulin therapy Group B (control group); will include 40 patients who will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations) All patients will be managed according to NICE guidelines for diabetes with pregnancy (2015) Maternal assessment
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Full history taking Baseline medical history is obtained along with other baseline demographics and concomitant medications including insulin regimen and dose.
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Thorough clinical examination Maternal weight, height and blood pressure measured and recorded.
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Laboratory investigations;
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Routine labs: CBC, coagulation profile, liver and kidney function at time of participation, 28-32 weeks of gestation especially renal parameter serum Creatinine.
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HbA1c at time of 1st examination.
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FBS, 2h post prandial blood sugar will be done weekly from time of participation till time of delivery
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Fundus examination for early detection of retinal affection at Ophthalmology clinic
Follow up:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diabetic pregnant patients with type one diabetes and no other chronic disorders
- •Patients on insulin in the 3rd trimester of pregnancy (on insulin therapy since start of gestation)
- •Patients pregnant in single living fetus with no apparent congenital anomalies
- •Haemoglobin A 1 C (HbA1c) level between 7% to 11%
- •All patients have done a dating ultrasound to confirm gestational age, viability and rule out any abnormality
排除标准
- •Patients with type 2 or gestational diabetes
- •Patients with intolerance or hypersensitivity to metformin
- •Patients with congestive heart failure or a history of congestive heart failure
- •Patients with renal insufficiency
- •Patients having current significant gastrointestinal problems such as severe vomiting requiring intravenous fluids or hospitalization
- •Presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis, a history of diabetic ketoacidosis or history of lactic acidosis
- •Patients with liver impairment
- •Patients with known higher order pregnancies (twins, triplets, etc.)
- •Patients having a known potentially fetal lethal anomaly
研究组 & 干预措施
combined metformin and insulin
干预措施: Metformin (Drug)
combined metformin and insulin
干预措施: Insulin (Drug)
Insulin only
干预措施: Insulin (Drug)
结局指标
主要结局
HbA1c
时间窗: 12 weeks
the change in level of glycosylated haemoglobin
fasting blood sugar measurement.
时间窗: 12 weeks
the change in level of glucose in venous blood after fasting for 8 hours
capillary glucose
时间窗: 12 weeks
the change in level of glucose in capillary blood
2 hours post prandial blood sugar measurement.
时间窗: 12 weeks
the change in level of glucose in venous blood 2 hours after meal
次要结局
- neonatal respiratory distress(12 weeks)
- neonatal hypoglycemia(12 weeks)
- neonatal Intensive care admission(12 weeks)
- Maternal weight gain(12 weeks)
- weekly fetal weight gain measured by ultrasound(12 weeks)
- insulin requirements(12 weeks)
- intra uterine fetal death (IUFD)(12 weeks)
- neonatal weight(12 weeks)
- attacks of maternal hypoglycemia(12 weeks)
- preterm birth(12 weeks)
研究者
Amira S Dieb
Assistant professor
Kasr El Aini Hospital