Table 2.
Summary statistics and estimated incidence rate ratios (IRRs) for specified primary and secondary outcomes
| Outcome | Control phase | Intervention phase | Adjusted IRR‡ (95% CI) |
||
| n* of 1335 | Crude rate (ratio†) |
n* of 1713 | Crude rate (ratio†) |
||
| Primary outcomes | |||||
| Stillbirths Stillbirth rate (per 1000 births) |
1326 | 24.6 (5529/224 649) |
1701 | 23.5 (4915/208 934) |
0.97 (0.91 to 1.05) |
| Newborns Early neonatal death rate (per 1000 live births) |
1326 | 9.3 (2038/219 120) |
1701 | 9.5 (1933/204 019) |
1.04 (0.92 to 1.17) |
| Maternal Institutional maternal mortality ratio (iMMR) (per 100 000 live births) |
1311 | 70.9 (154/217 134) |
1681 | 83.2 (167/200 695) |
1.23 (0.80 to 1.90) |
| Direct obstetric CFR | 1308 | 0.57% (124/21 767) |
1677 | 0.62% (123/19 691) |
1.15 (0.66 to 2.02) |
| Secondary outcomes | |||||
| iMMR for direct maternal deaths only | 1311 | 57.1 (124/217 134) |
1681 | 61.8 (124/200 695) |
1.24 (0.79 to 1.92) |
| iMMR for indirect maternal deaths only | 1311 | 13.8 (30/217 134) |
1681 | 21.4 (43/200 695) |
2.17 (0.87 to 5.40) |
| Obstetric case fatality rate (CFR) | |||||
| CFR—all complications (direct and indirect) | 1308 | 0.69% (154/22 287) |
1677 | 0.83% (166/19 902) |
1.14 (0.65 to 2.01) |
| Indirect obstetric CFR | 68 | 5.8% (30/520) |
74 | 20.4% (43/211) |
1.93 (1.25 to 3.01) |
| CFR by type of complication | |||||
| Haemorrhage§ | 894 | 0.93% (48/5147) |
1111 | 0.81% (43/5281) |
0.97 (0.60 to 1.56) |
| PPH§ | 622 | 2.0% (38/1860) |
787 | 1.6% (33/2106) |
0.77 (0.39 to 1.54) |
| Eclampsia | 821 | 0.67% (46/6823) |
913 | 0.86% (43/5011) |
2.22 (0.96 to 5.11) |
| Postpartum sepsis§¶ | 208 | 4.2% (24/565) |
241 | 5.3% (29/544) |
0.95 (0.38 to 2.34) |
| Obstructed labour | 826 | 0% (0/9114) |
1022 | 0% (0/8643) |
n/a |
| Ruptured uterus§¶ | 80 | 5.9% (6/101) |
105 | 4.1% (7/170) |
0.74 (0.21 to 2.64) |
| Complication rates | |||||
| Any complication | 1308 | 10.1% (22 287/219 937) |
1679 | 9.8% (20 090/205 398) |
1.14 (1.02 to 1.27) |
| Haemorrhage | 1305 | 2.4% (5148/218 881) |
1660 | 2.6% (5338/203 774) |
1.31 (1.13 to 1.52) |
| PPH | 1307 | 0.85% (1863/219 414) |
1678 | 1.04% (2133/205 918) |
1.27 (0.97 to 1.65) |
| Eclampsia | 1307 | 3.1% (6823/219 414) |
1679 | 2.5% (5076/206 380) |
0.95 (0.75 to 1.19) |
| Postpartum sepsis | 1305 | 0.26 (568/219 232) |
1679 | 0.27% (557/205 398) |
1.86 (1.17 to 2.95) |
| Obstructed labour | 1297 | 4.3% (9115/213 358) |
1674 | 4.3% (8797/204 195) |
1.12 (0.98 to 1.27) |
| Ruptured uterus | 1309 | 0.05% (102/220 833) |
1683 | 0.08% (171/206 191) |
1.19 (0.66 to 2.14) |
*n indicates the number of facility-month combinations for which any case was recorded, and could thus be included in the analysis.
†Unadjusted statistics aggregated across all facilities and months within phase to derive crude incidence rates.
‡Estimates are derived from mixed effects negative binomial models in which month of study, facility type and monthly numbers of births (≤30, 31–160 or >160) were included as fixed effects, with random effects for district and facility, unless indicated otherwise.
§Monthly number of births omitted from the analysis to enable estimates to be derived.
¶Facility type and random effect for facility omitted from the analysis to enable estimates to be derived.