TABLE 2.
Outcomes | Study design (number of patients) |
Relative effect Risk ratio (95% CI) |
Absolute effects a | Certainty of evidence GRADE b |
---|---|---|---|---|
Perinatal outcomes | ||||
Perinatal mortality |
1 RCT (n = 2078) 21 non‐RCT (n = 388 714) |
RR 0.27 c (0.076; 0.974) RR 0.36 (0.25; 0.51) |
0.3 vs. 1.1% 0.05% vs. 0.19% |
Low d ⊕⊕⃝⃝ |
Apgar score <7 at 5 min |
1 RCT (n = 2033) 18 non‐RCT (n = 217 024) |
RR 0.27 (0.12; 0.58) RR 0.1 (0.14; 0.26) |
0.8% vs. 3.0% 0.45% vs. 2.50% |
Moderate e ⊕⊕⊕⃝ |
Apgar score <4 at 5 min | 5 non‐RCT (n = 44 498) | RR 0.39 (0.19; 0.81) | 0.20% vs. 0.55% | Low ⊕⊕⃝⃝ |
Umbilical cord pH <7.0 (in our PICO <7.05 but <7.0 was reported in all articles) | 4 non‐RCT (n = 13 440) | RR 0.23 (0.12; 0.43) | 0.26% vs. 1.23% | Low f ⊕⊕⃝⃝ |
Base excess < −12 | 1 non‐RCT (n = 1684) | RR 0.14 (0.08; 0.24) | 1.7% vs. 11.9% | Low ⊕⊕⃝⃝ |
Admission to Neonatal Intensive Care Unit, >4 days |
1 RCT (n = 2000) 4 non‐RCT (n = 46 055) |
RR 0.67 (0.19; 2.36) RR 0.73 (0.57; 0.92) |
0.4% vs. 0.6% 2.45% vs. 3.72% |
Low g ⊕⊕⃝⃝ |
Traumatic birth injury |
1 RCT (n = 2000) 9 non‐RCT (n = 145 068) |
RR 0.43 (0.17; 1.11) RR 0.18 (0.13; 0.27) |
0.6% vs. 1.4% 0.20% vs. 0.67% |
Low g ⊕⊕⃝⃝ |
Hypoxic ischemic encephalopathy | Not reported | |||
Cerebral palsy >2 years | 3 non‐RCT (n = 26 155) | RR 1.03 (0.53; 2.01) | 0.13% vs. 0.13% | Low ⊕⊕⃝⃝ |
Intracranial bleeding | 3 non‐RCT (n = 27 192) | RR 0.24 (0.05; 1.08) | 0.02% vs. 0.11% | Low ⊕⊕⃝⃝ |
Neurodevelopmental problems | Reported in a wide variation of outcomes, see Table S2. | |||
Maternal outcomes | ||||
Maternal mortality |
1 RCT (n = 2083) 4 non‐RCT (n = 40 854) |
RR 0.33 (0.01; 8.18) RR 0.15 (0.01; 2.93) |
0% vs. 0.10% 0% vs. 0.02% |
Very low h ⊕⃝⃝⃝ |
Thrombo‐embolic event | 4 non‐RCT (n = 40 854) |
RR 1.25 (0.56; 2.80) |
0.08% vs. 0.05% |
Low ⊕⊕⃝⃝ |
Pelvic infection | 2 non‐RCT (n = 30 380) |
RR 1.03 (0.67; 1.56) |
1.2% vs. 1.2% |
Low ⊕⊕⃝⃝ |
Severe bleeding | Reported in a wide variation of outcomes, see Table S3. | |||
Delivery tract trauma | Reported in a wide variation of outcomes, see Table S3. | |||
Pelvic floor dysfunction (3 months and 2 years follow up) |
Reported in a wide variation of outcomes, see Table S3. The only significant differences were “having experienced urinary incontinence or incontinence of flatus” at 3 months. |
Placental or uterine complications in following pregnancies | Reported in a wide variation of outcomes, see Table S3. | |||
Other outcomes | ||||
Conversion of delivery mode from cesarean section to vaginal delivery | 1 RCT (n = 2088) | Not relevant | 9.6% | Low i ⊕⊕⃝⃝ |
Conversion of delivery mode from vaginal delivery to cesarean section |
1 RCT (n = 2088) 9 non‐RCT (n = 48 675) |
Not relevant |
43.3% 16%–51% (mean 38.0% median 41.8%) |
Moderate j ⊕⊕⊕⃝ |
The mother's experience of delivery |
Reported in a wide variation of outcomes, see Table S3. No significant differences at 3 months and 2 years follow up. |
Certainty of evidence | |
---|---|
High certainty ⊕⊕⊕⊕ | We are very confident that the true effect lies close to that of the estimate of the effect |
Moderate certainty ⊕⊕⊕⃝ | We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different |
Low certainty⊕⊕⃝ ◯ | Confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect |
Very low certainty ⊕⃝ ◯⃝ | We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
Absolute effects for event rates, presented as the sum of all events/the total numbers of participants, across the RCTs or cohort studies, respectively.
GRADE based primary on RCTs, or when not available on non‐RCTs.
Stillbirths excluded by us (n = 2).
Downgraded two levels due to serious limitations in study design and analysis, and serious imprecision.
Downgraded one level due to serious limitations in study design and uncertain precision.
Downgraded one level due to some limitations in study design, some uncertainty about directness, and uncertain precision.
Downgraded two levels due to serious limitations in study design, serious imprecision, and some uncertainty about directness.
Downgraded three levels due to serious limitations in study design, some uncertainty about directness, and very serious imprecision.
Downgraded two levels due to some limitations in study design and very serious indirectness.
Downgraded one level due to some limitations in study design.