Metformin in Gestational Diabetes and type2 Diabetes in Pregnancy in a Developing Country
试验速览
- 阶段
- 2 期
- 入组人数
- 300
- 主要终点
- Alive baby
研究概览
简要总结
The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy metformin treatment compared with insulin will result in better perinatal and maternal outcome and improved treatment acceptability with low or noadditional insulin requirement.
详细描述
METHODOLOGY:
This randomized clinical study comparing metformin and insulin in the treatment of gestational diabetes and type 2 diabetes in pregnancy was conducted between December 2008 till December 2012 in the tertiary care university hospital of Lyari General Hospital and Dow University of Health Sciences and in four other private obstetric (maternity) hospitals of Karachi. The study was approved by the ethics committee of Dow University of Heath Sciences. A written informed consent was taken from the participants of the study and the consequences and suspected outcomes were informed.
The patients were selected from those attending the antenatal clinic with previously diagnosed type 2 diabetes or were screened in antenatal clinic due to presence of high risk factors for diabetes mellitus and were found to have impaired glucose tolerance (IGT) or gestational diabetes mellitus (GDM).
All pregnant women were subjected to screening after evaluation of high risk factors at their first antenatal visit irrespective of gestational age in order to pick undiagnosed type 2 diabetes early in pregnancy. Women who were screen negative at first antenatal visit were subjected to repeat screening at 24-28 weeks and 32-36 weeks.
A 50gm oral glucose challenge test (GCT) was done as an initial screening test irrespective of the fasting status and a blood sugar level of 140gm/dl was considered as a positive GCT. Gestational diabetes was then diagnosed by a 2 hour 75gm oral glucose tolerance test (OGTT) after an over night fast of 10 hours. Diagnosis of GDM was made with at least two out of three abnormal high plasma glucose levels in a 75gm OGTT FBS> 95, 1 hour ≥180 and 2 hour ≥155.
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
- None
入排标准
- 年龄范围
- 20 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Women who have contraindication for metformin intake.
- •A recognized fetal anomaly at 14-16 weeks ultrasound examination at the time of study entry.
- •Ruptured membranes at time of study entry.
- •Women with IDDM (Type 1 DM) entering pregnancy.
- •Presence of any other medical disorder like essential hypertension, renal disease, hepatic disease, hypothyroidism, cardiac disease.
- •Presence of diabetic complications.
- •Patient already on Sulphonylureas.
- •Multiple pregnancy.
- •Gestational diabetes controlled on diet alone.
研究组 & 干预措施
metformin
group A1:Consists of patients with GDM who were given drug metformin as treatment group B1:Consists of patients with type 2 diabetes in pregnancy were given the drug metformin as treatment intervention with drug metformin is given for control of diabetes in esclation dose of 500mg /day upto 2.5 grams per day in two to three divided doses till delivery
干预措施: Metformin (Drug)
insulin
GroupA2:gestational diabetes on insulin treatment Group B2:type 2 diabetes on insulin treatment intervention:insulin treatment till delivery
干预措施: Insulin (Drug)
结局指标
主要结局
Alive baby
时间窗: At birth, up to 28 days after birth
it will include alive , neonatal death and still born
Neonatal morbidity
时间窗: at birth upto 28 days after birth
it will include birth weight, macrosomia,neonatal hypoglycemia,transient tachypnoea of newborn ,respiratory distress syndrome,neonatal intensive care admissions, prematurity,sepsis,neonatal jaundice,birth trauma.
次要结局
- glycemic control(day1 (study entry ) till devlivery)
- weight gain in prenancy(day 1 (study entry) till delivery)
- Maternal hypertensive complications(day 1(study entry ) till 1 week after delivery)
研究者
Jahan Ara Ainuddin
Associate professor obgyn duhs
Dow University of Health Sciences