Table 3.
GRADE Profile.
| Certainty assessment | No. of patients | Effect | Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Telemedicine | Usual care | Relative (95% CI) | Absolute (95% CI) | ||
| Infant birth weight | ||||||||||||
| 10 | Randomized trials | Not serious | Not serious | Not serious | Serious a | None | 471 | 428 | — | MD 19.34 g higher (47.8 lower to 86.47 higher) | ⨁⨁⨁◯ Moderate |
|
| Hypoglycemic events (mother) | ||||||||||||
| 2 | Randomized trials | Serious b | Not serious | Not serious | Very serious c | None | 26 | 25 | — | SMD 0.34 SD lower (0.9 lower to 0.22 higher) |
⨁◯◯◯ Very low |
|
| HbA1c% | ||||||||||||
| 5 | Randomized trials | Not serious | Not serious | Not serious | Very serious a | None | 148 | 140 | — | MD 0.14 lower (0.51 lower to 0.23 higher) |
⨁⨁◯◯ Low |
|
| Fasting blood glucose | ||||||||||||
| 4 | Randomized trials | Serious d | Not serious | Not serious | Serious a | None | 134 | 131 | — | MD 0.12 mg/dL lower (3.13 lower to 2.89 higher) |
⨁⨁◯◯ Low |
|
| Two-hour glucose tolerance | ||||||||||||
| 2 | Randomized trials | Not serious | Not serious | Serious e | Very serious a | None | 164 | 175 | — | MD 9.62 mg/dL higher (1.95 higher to 17.28 higher) |
⨁◯◯◯ Very low |
|
| Weight gain during pregnancy (mother) | ||||||||||||
| 2 | Randomized trials | Not serious | Not serious | Not serious | Very serious a | None | 150 | 154 | — | SMD 0 SD (0.22 lower to 0.23 higher) |
⨁⨁◯◯ Low |
|
| Pregnancy-induced hypertension/preeclampsia | ||||||||||||
| 7 | Randomized trials | Not serious | Not serious | Not serious | Very serious a | None | 29/352 (8.2%) | 26/350 (7.4%) | Log odds 0.21 (−0.37 to 0.79) | — per 1000 (from — to —) | ⨁⨁◯◯ Low |
|
| Gestational age at delivery | ||||||||||||
| 11 | Randomized trials | Not serious | Not serious | Not serious | Serious a | None | 504 | 478 | — | MD 0.05 weeks lower (0.24 lower to 0.14 higher) |
⨁⨁⨁◯Moderate | |
| Induced labor | ||||||||||||
| 3 | Randomized trials | Not serious | Not serious | Not serious | Very serious a | None | 104/221 (47.1%) | 110/233 (47.2%) | Log odds 0.00(−0.37 to 0.38) | — per 1000 (from — to —) |
⨁⨁◯◯ Low |
|
| Cesarean delivery | ||||||||||||
| 11 | Randomized trials | Not serious | Serious f | Not serious | Serious a | None | 191/595 (32.1%) | 209/575 (36.3%) | Log odds −0.11(−0.50 to 0.27) | — per 1000(from — to —) | ⨁⨁◯◯ Low |
|
| Preterm delivery | ||||||||||||
| 3 | Randomized trials | Serious d | Not serious | Not serious | Very serious a | None | 10/117 (8.5%) | 12/111 (10.8%) | Log odds −0.38(−1.31 to 0.55) | — per 1000 (from — to —) |
⨁◯◯◯ Very low |
|
| Premature membrane rupture | ||||||||||||
| 2 | Randomized trials | Serious d | Serious g | Not serious | Very serious a | None | 3/68 (4.4%) | 3/65 (4.6%) | Log odds 0.00(−3.13 to 3.13) | — per 1000(from — to —) | ⨁◯◯◯ Very low |
|
| Placental abruption | ||||||||||||
| 2 | Randomized trials | Serious d | Not serious | Not serious | Very serious a | None | 1/81 (1.2%) | 1/73 (1.4%) | Log odds −0.14(−2.14 to 1.87) | — per 1000 (from — to —) |
⨁◯◯◯ Very low |
|
| Stillbirth | ||||||||||||
| 2 | Randomized trials | Not serious | Not serious | Not serious | Very serious a | Publication bias strongly suspected h | 0/81 (0.0%) | 1/86 (1.2%) | Log odds −0.58(−3.02 to 1.86) | — per 1000 (from — to —) |
⨁◯◯◯ Very low |
|
| Neonatal hypoglycemia | ||||||||||||
| 7 | Randomized trials | Not serious | Not serious | Not serious | Serious a | None | 51/358 (14.2%) | 44/354 (12.4%) | Log odds 0.19(−0.27 to 0.64) | — per 1000 (from — to —) |
⨁⨁⨁◯ Moderate |
|
| Jaundice | ||||||||||||
| 5 | Randomized trials | Not serious | Not serious | Not serious | Very serious a | None | 26/238 (10.9%) | 26/240 (10.8%) | Log odds 0.14(−0.47 to 0.76) | — per 1000 (from — to —) |
⨁⨁◯◯ Low |
|
| Shoulder dystocia | ||||||||||||
| 4 | Randomized trials | Not serious | Not serious | Not serious | Very serious a | None | 1/234 (0.4%) | 10/236 (4.2%) | Log odds −1.34 (−2.61 to −0.08) |
— per 1000 (from — to —) |
⨁⨁◯◯ Low |
|
| Infant respiratory distress | ||||||||||||
| 3 | Randomized trials | Serious d | Not serious | Not serious | Very serious a | None | 8/89 (9.0%) | 12/89 (13.5%) | Log odds −0.53(−1.49 to 0.44) | — per 1000(from — to —) | ⨁◯◯◯ Very low |
|
| Neonates large for gestational age | ||||||||||||
| 5 | Randomized trials | Serious d | Not serious | Not serious | Very serious a | None | 30/189 (15.9%) | 21/180 (11.7%) | Log odds 0.34 (−0.26 to 0.94) |
— per 1000(from — to —) | ⨁◯◯◯ Very low |
|
| Admissions to neonatal intensive care | ||||||||||||
| 7 | Randomized trials | Not serious | Not serious | Not serious | Serious a | None | 57/423 (13.5%) | 61/403 (15.1%) | Log odds −0.12 (−0.53 to 0.28) |
— per 1000(from — to —) | ⨁⨁⨁◯ Moderate |
|
Abbreviations: GRADE, Grading of Recommendations, Assessment, Development, and Evaluation; CI, confidence interval; MD, mean difference; SMD, standardized mean difference; HbA1c, glycated hemoglobin A1c.
a
Recommendation would be different depending on whether or not the lower or the upper boundary of the confidence interval is the true underlying effect. Furthermore, evidence fails to meet the optimal information criteria.
b
One of the two studies had a high risk of bias.
c
Only two small studies, broad confidence intervals, not fulfilling optimal information size.
d
Studies with high weights in meta-analysis have serious or moderate problems with bias.
e
Assessed up to three months post partum.
f
Point estimates vary, test for similar effect size statistically significant, heterogeneity large.
g
Point estimates vary, heterogeneity large.
h
Studies assigned dominant weight in meta-analysis in favor of telemedicine is industry sponsored.