Table 5.
Birth defects reported from the time of delivery to 14 weeks by exposure group
| Artemether-lumefantrine (N = 466) |
Sulphadoxine-pyrimethamine (N = 467) |
|
|---|---|---|
| Total number infants with malformationsa - n (%) | 29/449b (6.5) | 18/444b (4.1) |
| Diagnosis of congenital anomaly/birth defect | ||
| Umbilical hernia | 21 (4.7) | 12 (2.7) |
| Polydactyly | 3 (0.7) | 4 (0.9) |
| Dermal cyst | 0 (-) | 1 (0.2) |
| Ear malformation | 0 (-) | 1 (0.2) |
| Genitourinary system: small labiac | 1 (0.2) | 0 (-) |
| Hair: lanugoc | 1 (0.2) | 0 (-) |
| Inguinal hernia | 0 (-) | 1 (0.2) |
| Limbs: hyperextensibility of joint | 1 (0.2) | 0 (-) |
| Nose: smallc | 1 (0.2) | 0 (-) |
| Skin hyperpigmentation | 1 (0.2) | 0 (-) |
| Trisomy 18d | 1 (0.2) | 0 (-) |
| Trisomy 21e | 1 (0.2) | 0 (-) |
Enrolled population: newborn infants.
No distinction was made between major and minor birth defects on the case report form.
aAny malformation = any finding other than normal or any diagnosis of congenital anomaly/birth defect reported.
bNumber of newborn infants with assessment performed at least once at delivery, 6 weeks, or 14 weeks post-delivery. No assessments were available for 17 infants in the AL group and 23 in the SP group.
cReported in the same patient.
dReported malformations: Ears - low set; Mouth - high arched palate; Cranium - microencephaly/anencephaly; Limbs - clenched with overlapping fingers.
eReported malformations: Ears - low set; Mouth - high arched palate; CVS murmur; Chest - short sternum; Cranium - low occiput; Eyes - upward slanting; Mouth - protruding tongue; Neck - short; Nose - low nasal bridge.
In the SP group, one child was reported to have had umbilical hernia and polydactyly.