TABLE 4.
Serious adverse events1
| Placebo(n = 147) |
DHA(n = 154) |
|||
| Total n | n | Total n | n | |
| Mother | ||||
| Hospitalization or miscarriage | 18 | — | 18 | — |
| Body | — | 12 | — | 23 |
| Cardiology/blood | — | 3 | — | 2 |
| Gastrointestinal | — | 2 | — | 0 |
| Head/neck/mental | — | 0 | — | 1 |
| Miscarriage | — | 3 | — | 4 |
| Other pregnancy | — | 64 | — | 65 |
| Respiratory | — | 1 | — | 1 |
| Urogenital | — | 2 | — | 2 |
| Postpartum hospitalization | 3 | — | 1 | — |
| Wound healing | — | 2 | — | 0 |
| Mastitis | — | 1 | — | 0 |
| Suicide ideation | — | 0 | — | 1 |
| Infant | ||||
| Hospitalization and death | 31 | — | 26 | — |
| NICU at birth | — | 13 | — | 13 |
| Newborn death | — | 1 | — | 1 |
| Discharge to 30 d | — | 4 | — | 6 |
| 31 d to 18 mo | — | 126 | — | 77 |
| Infant death, SIDS | — | 1 | — | 0 |
| Congenital anomalies | 2 | — | 5 | — |
| Ileal atresia/short gut | — | 1 | — | 0 |
| Hypospadias | — | 1 | — | 1 |
| Cystic fibrosis | — | 0 | — | 1 |
| Tetralogy of Fallot | — | 0 | — | 1 |
| Coronal synostosis | — | 0 | — | 1 |
| Duplicated left ureter | — | 0 | — | 1 |
1
NICU, neonatal intensive care unit; SIDS, sudden infant death syndrome.
2
Fever.
3
One flank pain, one viral syndrome.
4
Includes 3 premature rupture of membranes, 1 placental abruption, 1 threatened preterm labor, and 1 observation of Rh isoimmunization.
5
Includes 2 premature rupture of membranes, 1 chorioamnionitis, 1 endomyometritis, 1 high blood pressure, and 1 abnormal Doppler results.
6
Two were hospitalized twice.
7
Includes an infant hospitalized twice for cystic fibrosis.