Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. A Systematic Review and Meta-analysis of Randomized Controlled Trials Comparing These Drugs Either vs Insulin or vs Each Other.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,509
- 试验地点
- 1
- 主要终点
- 3rd trimester glycated hemoglobin
研究概览
简要总结
Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM), additional studies of oral agents for the treatment of GDM have been published (observational, randomized controlled trials (RCT), and trials using other drugs like metformin).
Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4 RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs, the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing metformin vs insulin).
Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize this evidence using meta-analysis tools. Specifically, investigators aim at producing distinct meta-analyses for each one of the three drug comparisons. This information is not available in the literature since the most recent systematic reviews specifically dealing on oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)
详细描述
This project involves the systematic review of RCT addressing the use of glyburide or metformin for the treatment of GDM. The review will include RCT comparing these drugs versus insulin or making direct comparisons between the two oral agents in pregnant women with GDM.
Investigators have pre-specified a series of maternal and fetal outcomes of interest.
A comprehensive electronic search strategy will be complemented with a search of bibliographies from relevant studies and the contact of authors from the eligible studies regarding issues on study design or information on primary outcomes.
The risk of bias of included studies will be analyzed and this information used to perform sensitivity analyses. If possible, data from original studies will be pooled into relative risks for dichotomous outcomes and mean differences for continuous outcomes.
Heterogeneity will be explored for all the analyses. Analyses will be undertaken using a fixed effects model that will be repeated using a random effects model in case of substantial heterogeneity.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •comparing Glyburide vs Insulin, Metformin vs Insulin or Metformin vs Glyburide
- •data on fetal and/or maternal outcomes
- •full text available
排除标准
- •significant overlap with other articles of the same group
研究组 & 干预措施
Insulin (Glyburide vs Insulin)
Glyburide vs Insulin trials
干预措施: Glyburide vs Insulin trials (Drug)
Metformin (Metformin vs Insulin)
Metformin vs Insulin trials
干预措施: Metformin vs Insulin trials (Drug)
Glyburide (Glyburide vs Insulin)
Glyburide vs Insulin trials
干预措施: Glyburide vs Insulin trials (Drug)
Insulin (Metformin vs Insulin)
Metformin vs Insulin trials
干预措施: Metformin vs Insulin trials (Drug)
Metformin (Metformin vs Glyburide)
Metformin vs Glyburide trials
干预措施: Metformin vs Glyburide trials (Drug)
Glyburide (Metformin vs Glyburide)
Metformin vs Glyburide trials
干预措施: Metformin vs Glyburide trials (Drug)
结局指标
主要结局
3rd trimester glycated hemoglobin
时间窗: 3rd trimester of pregnancy
mean difference of 3rd trimester glycated hemoglobin
total maternal weight gain
时间窗: during pregnancy
mean difference of total maternal weight gain (as defined by the authors)
severe maternal hypoglycemia
时间窗: from enrollment to delivery
relative risk of severe maternal hypoglycemia (as defined by the authors)
preeclampsia
时间窗: during pregnancy or puerperium
relative risk of preeclampsia (as defined by the authors)
cesarean section
时间窗: at the end of pregnancy
relative risk of cesarean section (as defined by the authors)
gestational age at birth
时间窗: at birth
mean difference of gestational age at birth (as defined by the authors)
preterm birth
时间窗: at birth
relative risk of preterm birth (as defined by the authors)
birthweight
时间窗: at birth
mean difference of birthweight (as defined by the authors)
macrosomia
时间窗: at birth
relative risk of macrosomia (defined as birthweight \>=4000 g)
large-for-gestational age newborn
时间窗: at birth
relative risk of large-for-gestational age newborn (as defined by the authors)
small-for-gestational age newborn
时间窗: at birth
relative risk of small-for-gestational age newborn (as defined by the authors)
neonatal hypoglycemia
时间窗: in the neonatal period
relative risk of neonatal hypoglycemia (as provided by the authors)
perinatal mortality
时间窗: in the perinatal period
relative risk of perinatal mortality (as defined by the authors)
insulin treatment
时间窗: from enrollment to delivery
relative risk of insulin treatment (for trials comparing metformin vs glyburide)
次要结局
- maternal weight gain since enrollment(in the period from enrollment to delivery)
- pregnancy-induced hypertension(during pregnancy)
- induction of labour(at the end of pregnancy)
- cord C peptide(at birth)
- cord insulin(at birth)
- abnormal 1 min Apgar(at birth)
- abnormal 5 min Apgar(at birth)
- obstetric trauma(at birth)
- severe neonatal hypoglycemia(in the neonatal period)
- neonatal jaundice(in the neonatal period)
- significant respiratory distress(in the neonatal period)
- stillbirth(in the antenatal period)
- neonatal mortality(in the neonatal period)
- Neonatal Intensive Care Unit (NICU) admittance(in the neonatal period)
- fasting blood glucose(in the period from enrollment to delivery)
- postprandial blood glucose(in the period from enrollment to delivery)