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. 2023 Jan 3;60(5):595–608. doi: 10.1007/s00592-022-02016-5

Table 2.

Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) summary of neonatal outcomes of meta-analysis

Metformin vs. insulin for gestational diabetes mellitus
Patient population: patients with gestational diabetes mellitus
Intervention: metformin
Comparison: insulin
Outcomes Anticipated absolute effects RR/SMD (95%CI) No. of Participants
(Studies)
Certainty of the evidence (GRADE) Comments
Risk with Insulin Risk with Metformin
Birthweight

SMD -0.33

(-0.5 to -0.17)

4174

(22 RCTs)

⨁⨁◯◯

Low

Most of researches have limitations in methodology

Unexplained heterogeneity

Macrosomia 137 per 1,000 93 per 1,000

RR 0.68

(0.54 to 0.86)

3484

(20 RCTs)

⨁⨁⨁◯

Moderate

Researches have limitations in methodology
LGA 188 per 1,000 162 per 1,000

RR 0.86

(0.73 to 1.02)

2843

(12 RCTs)

⨁⨁⨁◯

Moderate

Most of researches have limitations in methodology
SGA 75 per 1,000 75 per 1,000

RR 1.00

(0.77 to 1.30)

2812

(12 RCTs)

⨁⨁◯◯

Low

Most of researches have limitations in methodology

Unexplained heterogeneity

Birth Height

SMD -0.09

(-0.27 to -0.08)

1084

(3 RCTs)

⨁◯◯◯

Very low

Researches have limitations in methodology

Very few RCTs lead to imprecision of estimate

Unexplained heterogeneity

NICU admission 207 per 1000 151 per 1000

RR 0.73

(0.61 to 0.88)

3527

(18 RCTs)

⨁⨁⨁◯

Moderate

Most of researches have limitations in methodology
Hypoglycemia 164 per 1000 107 per 1000

RR 0.65

(0.54 to 0.84)

3670

(20 RCTs)

⨁⨁◯◯

Low

Most of researches have limitations in methodology

2. There is a possibility of publication bias in these studies

GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our confidence in the estimate of the effect

Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of the effect and may change the estimate

Low quality: Further research is very likely to have an important impact on our confidence in the estimate of the effect and is likely to change the estimate

Very low quality: We are very uncertain about the estimate

RCTs Randomized controlled trials; CI confidence interval; RR risk ratio; SMD Std mean difference