Table 3:
Safety outcomes by study group
| n | Intervention group n/N (%) |
Control group n/N (%) |
Fisher’s p-value | |
|---|---|---|---|---|
| Elevated serum creatinine (grade 1 or higher) | ||||
| 3 months | 179 | 0/89 (0.0%) | 0/90 (0.0%) | -- |
| 6 months | 171 | 0/89 (0.0%) | 0/83 (0.0%) | -- |
| Intimate partner violence | ||||
| 3 months | 179 | 1/90 (1.1%) | 0/89 (0.0%) | 1.0 |
| 6 months | 171 | 5/89 (5.7%) | 1/83 (1.2%) | 0.2 |
| Other social harms | ||||
| 3 months | 179 | 0/90 (0.0%) | 2/89 (2.2%) | 0.2 |
| 6 months | 171 | 1/88 (1.1%) | 2/83 (2.4%) | 0.6 |
| Obstetric Complications | ||||
| Maternal Sepsis | 188 | 2/95 (2.1%) | 0/93 (0.0%) | 0.4 |
| Preeclampsia/Eclampsia | 188 | 2/95 (2.1%) | 0/93 (0.0%) | 0.5 |
| Antepartum Hemorrhage | 188 | 1/95 (1.1%) | 0/93 (0.0%) | 1.0 |
| Postpartum Hemorrhage | 188 | 0/95 (0.0%) | 2/93 (2.2%) | 0.2 |
| Adverse Birth Outcomes | ||||
| Preterm birth (< 37 weeks) | 188 | 5/95 (5.3%) | 6/93 (6.5%) | 0.7 |
| Stillbirth/Intrauterine fetal death | 188 | 7/95 (7.3%) | 2/93 (2.2%) | 0.2 |
| Miscarriage/Spontaneous abortion | 188 | 1/95 (1.1%) | 1/93 (1.1%) | 1.0 |
| Neonatal Death* | 178 | 3/88 (3.4%) | 2/90 (2.2%) | 0.7 |
| New maternal HIV infection | 171 | 0/89 (0.0%) | 1/83 (1.2%) | 0.5 |
*
Among women who reported a live birth