TABLE 6.
Key Outcomes for Comparison 1: DCC Versus ECC
| Outcomes | No. Participants (Studies) Follow-up | Certainty of the Evidence | RR (95% CI) | Absolute Risk Difference/MD (95% CI) | I2, % |
|---|---|---|---|---|---|
| Neonatal outcomes | |||||
| Survival to discharge from hospital | 2988 (16 RCTs) | ⊕⊕⊕⊝ Moderatea,b | RR: 1.02 (0.993 to 1.04) | RD: 0.02 (−0.00 to 0.04) | 0 |
| Severe IVH: ultrasound diagnosis grades III, IV | 2972 (14 RCTs) | ⊕⊕⊝⊝ Lowc,d | RR: 0.98 (0.67 to 1.42) | RD: −0.00 (−0.01 to 0.01) | 0 |
| Chronic lung disease: oxygen at 36 wk PMA | 2427 (10 RCTs) | ⊕⊕⊕⊕ Higha | RR: 1.03 (0.94 to 1.13) | RD: 0.01 (−0.02 to 0.04) | 0 |
| NEC (Bell’s stage ≥II or any grade47) | 2745 (14 RCTs) | ⊕⊕⊕⊝ Moderatea,e | RR: 0.83 (0.61 to 1.13) | RD: −0.01 (−0.03 to 0.01) | 0 |
| Peak Hb concentrations within the first 24 h after birth | 196 (4 RCTs) | ⊕⊕⊕⊝ Moderatea,f | Continuous outcome | MD: 1.24 (0.01 to 2.47) | 79 |
| Peak Hct within the first 24 h after birth | 1100 (14 RCTs) | ⊕⊕⊕⊕ Higha | Continuous outcome | MD: 2.63 (1.85 to 3.42) | 5 |
| Peak Hb concentrations within 7 d after birth | 100 (1 RCT) | ⊕⊕⊕⊝ Moderatea,g | Continuous outcome | MD: 9.50 (8.27 to 10.28) | Not estimable |
| Peak Hct within 7 d after birth | 1550 (1 RCT) | ⊕⊕⊕⊕ Higha,h | Continuous outcome | MD: 2.70 (1.88 to 3.52) | Not estimable |
| Hyperbilirubinemia (treated by phototherapy) | 908 (6 RCTs) | ⊕⊕⊕⊕ Higha | RR: 0.99 (0.95 to 1.03) | RD: −0.01 (−0.04 to 0.03) | 0 |
| Infant outcomes | |||||
| Moderate to severe neurodevelopmental impairment in early childhood | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Cerebral palsy in early childhood | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Significant mental developmental delay in early childhood | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Legal blindness in early childhood (<20/200 visual acuity) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Hearing deficit in early childhood (aided or <60 dB on audiometric testing) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Maternal outcomes | |||||
| PPH (clinically estimated blood loss of ≥500 mL) | 1477 (3 RCTs) | ⊕⊝⊝⊝ Very lowd,i,j | RR: 0.93 (0.54 to 1.62) | RD: 0.02 (−0.08 to 0.12) | 52 |
| Maternal death or severe morbidity | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Severe PPH (blood loss ≥1000 mL) | 254 (1 RCT) | ⊕⊝⊝⊝ Very lowi,k,l | RR: 0.81 (0.38 to 1.73) | −0.02 (−0.09 to 0.05) | Not estimable |
| Use of therapeutic uterotonic agents | 1566 (1 RCT) | ⊕⊕⊕⊕ Highk | RR: 1.00 (0.97 to 1.04) | 0.00 (−0.02 to 0.03) | Not estimable |
| Blood transfusion (maternal) | 715 (2 RCTs) | ⊕⊕⊝⊝ Lowl,m | RR: 1.82 (0.78 to 4.23) | 0.02 (−0.01 to 0.04) | 0 |
| Manual removal of the placenta | 105 (1 RCT) | ⊕⊕⊝⊝ Lowk,l,m | RR: 0.99 (0.32 to 3.04) | −0.00 (−0.12 to 0.12) | Not estimable |
| Additional treatment of PPH (uterine tamponade, embolization) | 0 (0 studies) | — | Not estimable | Not estimable | Not estimable |
| Postpartum infection | 254 (1 RCT) | ⊕⊕⊝⊝ Lowk,m,n | RR: 1.12 (0.73 to 1.72) | 0.03 (−0.08 to 0.13) | Not estimable |
Hb, hemoglobin; Hct, hematocrit; NA, not applicable; PMA, postmenstrual age; PPH, postpartum hemorrhage; RD, risk difference. —, not applicable; ⊕, positive; ⊝, negative.
Some concerns from lack of participant and personnel blinding in most studies. No downgrade for risk of bias because outcome unlikely to be influenced by this. This is a borderline decision.
CI includes null effect, or clinically important outcome of 36 more survivals per 1000. Downgrade by 1 for imprecision. This is a borderline decision.
Largest study (>50% wt) unblinded for outcome assessment. Severe IVH assessment can be subjective. Downgrade by 1 for risk of bias.
CI includes clinically important increase and clinically important decrease. Downgrade by 1 for imprecision.
CI includes clinically important decrease and no effect. Downgrade by 1 for imprecision.
Substantial heterogeneity. Direction of effect the same across all studies. Downgrade by 1 for inconsistency.
Only one 100-ppt single-center study impairs generalizability. Downgrade by 1 for indirectness.
Unable to assess inconsistency (only 1 study). No downgrade.
All studies unblinded for intervention and outcome assessment. Subjective outcome; may have been influenced by lack of blinding. Downgrade by 1 for risk of bias.
Moderate heterogeneity. Downgrade by 1 for inconsistency.
Unable to assess inconsistency (only 1 study). No downgrade.
Very large CI and low event rates. Downgrade by 2 for imprecision.
Some concerns due to lack of participant and personnel blinding. No downgrade for risk of bias because outcome unlikely to be influenced by this. This is a borderline decision.
Only 1 study, large CI, low event rates. Downgrade by 2 for imprecision. (Borderline decision whether to downgrade by 1 or 2).