Gestational Diabetes Mellitus
Conditions
Keywords
gestational diabetes mellitus, glyburide, metformin, oral agents, insulin, outcomes
Brief summary
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)
Detailed description
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. Results of the systematic review will be published following PRISMA guidance.
Interventions
DRUGGlyburide vs Insulin trials
Affecting groups 1 and 2
DRUGMetformin vs Insulin trials
Affecting groups 3 and 4
DRUGMetformin vs Glyburide trials
Affecting groups 5 and 6
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* RCT * GDM * comparing Glyburide vs Insulin, Metformin vs Insulin or Metformin vs Glyburide * data on fetal and/or maternal outcomes * full text available
Exclusion criteria
* significant overlap with other articles of the same group
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3rd trimester glycated hemoglobin | 3rd trimester of pregnancy | mean difference of 3rd trimester glycated hemoglobin |
| total maternal weight gain | during pregnancy | mean difference of total maternal weight gain (as defined by the authors) |
| insulin treatment | from enrollment to delivery | relative risk of insulin treatment (for trials comparing metformin vs glyburide) |
| severe maternal hypoglycemia | from enrollment to delivery | relative risk of severe maternal hypoglycemia (as defined by the authors) |
| preeclampsia | during pregnancy or puerperium | relative risk of preeclampsia (as defined by the authors) |
| cesarean section | at the end of pregnancy | relative risk of cesarean section (as defined by the authors) |
| gestational age at birth | at birth | mean difference of gestational age at birth (as defined by the authors) |
| preterm birth | at birth | relative risk of preterm birth (as defined by the authors) |
| birthweight | at birth | mean difference of birthweight (as defined by the authors) |
| macrosomia | at birth | relative risk of macrosomia (defined as birthweight \>=4000 g) |
| large-for-gestational age newborn | at birth | relative risk of large-for-gestational age newborn (as defined by the authors) |
| small-for-gestational age newborn | at birth | relative risk of small-for-gestational age newborn (as defined by the authors) |
| neonatal hypoglycemia | in the neonatal period | relative risk of neonatal hypoglycemia (as provided by the authors) |
| perinatal mortality | in the perinatal period | relative risk of perinatal mortality (as defined by the authors) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| significant respiratory distress | in the neonatal period | relative risk of significant respiratory distress (described as respiratory distress syndrome or requiring respiratory support) |
| fasting blood glucose | in the period from enrollment to delivery | mean difference of fasting blood glucose (as defined by the authors) |
| Neonatal Intensive Care Unit (NICU) admittance | in the neonatal period | relative risk of NICU admittance (as defined by the authors) |
| postprandial blood glucose | in the period from enrollment to delivery | mean difference of postprandial blood glucose (as defined by the authors) |
| maternal weight gain since enrollment | in the period from enrollment to delivery | mean difference of maternal weight gain since enrollment (as defined by the authors) |
| pregnancy-induced hypertension | during pregnancy | relative risk of pregnancy-induced hypertension (as defined by the authors) |
| induction of labour | at the end of pregnancy | relative risk of induction of labour (as described by the authors) |
| cord C peptide | at birth | mean difference of cord C peptide (as defined by the authors) |
| cord insulin | at birth | mean difference of cord insulin (as defined by the authors) |
| abnormal 1 min Apgar | at birth | relative risk of abnormal 1 min Apgar (defined as lower than 7) |
| abnormal 5 min Apgar | at birth | relative risk of abnormal 5 min Apgar (defined as lower than 7) |
| obstetric trauma | at birth | relative risk of obstetric trauma (as defined by the authors) |
| severe neonatal hypoglycemia | in the neonatal period | relative risk of severe neonatal hypoglycemia (as defined by the authors) |
| stillbirth | in the antenatal period | relative risk of stillbirth (as defined by the authors) |
| neonatal mortality | in the neonatal period | relative risk of neonatal mortality (as defined by the authors) |
| neonatal jaundice | in the neonatal period | relative risk of neonatal jaundice (as defined by the authors) |
Countries
Spain
Outcome results
None listed