Efficacy of Metformin in Pregnant Obese Women, a Randomised Controlled Trial. - EMPOWaR

niversity of Edinburgh0 个研究点目标入组 400 人开始时间: 2010年3月17日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•Caucasian obese (BMI = 30 kg/m2) pregnant women between = 12-0 and = 16+0 weeks gestation
•Women age =16 years
•Signed informed consent form
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Non Caucasian women
•Women with a BMI = 29 kg/m2
•Gestation > than 16 weeks
•Women with pre-existing diabetes
•Women with gestational diabetes in a previous pregnancy
•Women with systemic disease requiring medication.
•Gestational diabetes in index pregnancy (diagnosed with 75g OGTT tested (WHO criteria prior to randomisation)
•A known pregnancy complications in this or a previous pregnancy likely to impact of birthweight or gestation at delivery
•A known hypersensitivity to metformin hydrochloride or to any of the excipient.
•Known abnormalities of the liver (tested prior to randomisation)
•Renal failure or renal dysfunction
•Acute conditions with the potential to alter renal function such as:
•odehydration,
•osevere infection,
•ointravascular administration of iodinated contrast agents
•oAcute or chronic diseases which may cause tissue hypoxia such as:
•ocardiac or respiratory failure,
•orecent myocardial infarction,
•ohepatic insufficiency, acute alcohol intoxication, alcoholism,

发起方

niversity of Edinburgh