Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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.
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)


Options:
A: Inclusion Criteria:Inclusion Criteria. Potential participants will be ≥ 0-36 years old, which includes the offspring of the pregnant mothers with GDM. Pregnant women will be between the ages of 18-40 years and will have a BMI of 26 - 35 kg/m2 at the time of diagnosis, a singleton pregnancy, and will not be taking medication for their GDM on entrance to the study. Subjects will have been diagnosed with GDM according to the criteria established by the ADA and the ACOG (19;35;53), specifically, they will meet the following criteria:

* A 50-gram Glucola in which the one hour reading is \>200 mg/dL and the FBG is \>95 mg/dL
* Two abnormal values on a 100-gram 3 hour glucose tolerance test based on the Coustan and Carpenter criteria as adopted by the ADA and Fourth International Workshop on Gestational Diabetes (76;77):

  * Fasting \> or = to 95 mg/dL but \<126 mg/dL
  * 1 hr \>/= 180 mg/dL
  * 2 hr \>/= 155 mg/dL
  * 3 hr \>/=140 mg/dL

Exclusion Criteria:Those women with overt diabetes and those suspected of having preexisting diabetes by any of the following criteria will be excluded, including:

* Fasting glucose \>110 mg/dL, due to the high likelihood of rapidly failing diet and requiring medical treatment (35).
* Random glucose \> 200 mg/dL
* Glycosylated hemoglobin A1C \> 6.5
* Non-English speaking patient
* Fasting TG \> 400 mg/dL

Women who smoke will be excluded since this is the leading cause of low birth weight. In addition, women with other risk factors for placental insufficiency, including hypertension requiring beta-blocker treatment, renal disease, thrombophilias, preeclampsia, steroid use, history of pancreatitis or infectious disease such as hepatitis, or intrauterine growth restriction will be excluded.

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B: Inclusion Criteria:

* Pregnant
* Gestational age at enrollment 24 - 31 weeks

Exclusion Criteria:

* Diabetes diagnosed prior to pregnancy
* Abnormal gestational diabetes (\>= 135 mg/dl) testing prior to 24 weeks' gestation
* Gestational diabetes in a previous pregnancy
* History of stillbirth or fetal death
* Pregnancy with more than one fetus
* Known major fetal anomaly
* Current or planned corticosteroid therapy
* Asthma requiring medication
* Current or planned beta adrenergic therapy
* Chronic hypertension requiring medication within 6 months of or during pregnancy
* Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease
* Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
* Maternal or fetal conditions likely to require preterm delivery, such as pre-eclampsia, preterm labor, or intrauterine growth retardation
* Previous or planned tocolytic therapy to induce labor or increase contraction strength
C: Inclusion Criteria:

* Gestational diabetes mellitus
* Single pregnancy

Exclusion Criteria:

* Multiple pregnancy
* High risk pregnancy (any other concomitant illness, excluding hypertension and obesity)
* Low ability to understand and follow a diet
* Need to use insulin different from regular insulin
D: 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

Answer: D