NCT01594697已完成不适用
Metformin in Pregnancy in Women With Polycystic Ovary Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- incidence of gestational diabetes
研究概览
简要总结
The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome (PCOS) women became pregnant during metformin treatment and continued taking the drug during gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were performed at each trimester of gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •age 18-40 yr,
- •metformin treatment for at least 3 months before entering the pregnancy,
- •gestational age between 5 and 12 wk
排除标准
- •diabetes mellitus
- •significant liver or renal impairment
- •neoplasms and other endocrine diseases
- •the use of drugs other than metformin able to interfere with glucose and insulin metabolism.
研究组 & 干预措施
metformin
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
incidence of gestational diabetes
次要结局
- number of newborns with macrosomia
- rate of spontaneous abortion
- number of hypertensive disorders
- number of live births
- incidence of delivery by caesarian section
研究者
Maurizio Guido
Principal Investigator
Catholic University of the Sacred Heart
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Metformin in Pregnant PCOS WomenPolycystic Ovary SyndromeNCT00159536Norwegian University of Science and Technology257
已完成
2 期
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot StudyPolycystic Ovary SyndromeNCT03259919Norwegian University of Science and Technology40
进行中（未招募）
1 期
PregMet 2 studyPoly Cystic Ovarial Syndrome (PCOS) in pregnant women. PCOS should be diagnosed according to the Rotterdam Consensus criterias:- at least 2 out of 3 criterias1.PCO in at least one ovary2.Oligo-/anovulation (clinically diagnosed as oligo-/amenorrhea,i.e. menstrual cycles > 35 days or <10 menstruations/year3.Hyperandrogenismclinical or biochemicalMedDRA version: 14.1Level: LLTClassification code 10065161Term: Polycystic ovarian syndromeSystem Organ Class: 100000004872EUCTR2011-002203-15-SETNU, Norwegian University of Science and Technology1,000
进行中（未招募）
1 期
PregMet 2 studyEUCTR2011-002203-15-ISTNU, Norwegian University of Science and Technology1,000
进行中（未招募）
1 期
PregMet 2 studyPoly Cystic Ovarial Syndrome (PCOS) in pregnant women. PCOS should be diagnosed according to the Rotterdam Consensus criterias: - at least 2 out of 3 criterias 1.PCO in at least one ovary 2.Oligo-/anovulation (clinically diagnosed as oligo-/amenorrhea,i.e. menstrual cycles > 35 days or <10 menstruations/year 3.Hyperandrogenismclinical or biochemicalMedDRA version: 20.0 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872EUCTR2011-002203-15-NOTNU, Norwegian University of Science and Technology1,000