Table 4.
Adverse events and serious adverse events (self-referral) (modified intention-to-treat population)
| Outcomes | Lateral episiotomy, no (%) (n=344) | No episiotomy, no (%) (n=358) | P value | Risk difference, % (95% CI) | Risk ratio (95% CI) |
|---|---|---|---|---|---|
| Adverse events | |||||
| Wound infection | 32 (9) | 17 (5) | 0.02 | 4.6 (0.8 to 8.5) | 1.96 (1.11 to 3.46) |
| Wound dehiscence | 32 (9) | 12 (3) | 0.001 | 6.0 (2.4 to 9.8) | 2.78 (1.45 to 5.30) |
| Granuloma or scarring | 14 (4) | 21 (6) | 0.27 | −1.8 (−5.2 to 1.5) | 0.69 (0.35 to 1.34) |
| Surgical treatment* | 25 (7) | 20 (6) | 0.36 | 1.7 (−2.0 to 5.5) | 1.30 (0.74 to 2.30) |
| Severe pain | 21 (6) | 26 (7) | 0.54 | −1.2 (−4.9 to 2.6) | 0.84 (0.48 to 1.47) |
| Fistula formation | 1 (<1) | 0 | 0.31 | 0.3 (−0.8 to 1.6) | N/A |
| Any of the above | 74 (22) | 62 (17) | 0.16 | 4.2 (−1.7 to 10.0) | 1.24 (0.92 to 1.68) |
| Serious adverse events | |||||
| Maternal death between days 0-42 | 0 | 0 | N/A | 0 | N/A |
| Maternal critical care† | 1 (<1) | 1 (<1) | 0.98 | 0.0 (−1.3 to 1.4) | 1.04 (0.07 to 16.57) |
| Persistent incapacity‡ | 4 (1) | 1 (<1) | 0.37 | 0.9 (−0.6 to 2.7) | 4.16 (0.47 to 37.06) |
| Neonatal death between days 0-28 | 0 | 0 | N/A | 0 | N/A |
N/A=not applicable.
Including re-suturing of wound or extirpation of granuloma.
One woman who required intensive care due to extreme blood loss and deranged coagulation because she refused to take blood for religious reasons; and one woman with septicaemia.
Persistent incapacity is defined as still ongoing after one year or with sequelae and were in these five cases one woman who required intensive care due to extreme blood loss and deranged coagulation because she refused to take blood for religious reasons; one woman with fistula formation; and two women with wound dehiscence; and one with granuloma that the site principal investigator deemed had recovered but with sequelae.