Safety of artemether-lumefantrine in pregnant women with malaria: results of a prospective cohort study in Zambia

Malaria Journal

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 malformations ^a - n (%)	29/449^b (6.5)	18/444^b (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 labia^c	1 (0.2)	0 (-)
Hair: lanugo^c	1 (0.2)	0 (-)
Inguinal hernia	0 (-)	1 (0.2)
Limbs: hyperextensibility of joint	1 (0.2)	0 (-)
Nose: small^c	1 (0.2)	0 (-)
Skin hyperpigmentation	1 (0.2)	0 (-)
Trisomy 18^d	1 (0.2)	0 (-)
Trisomy 21^e	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.

ISSN: 1475-2875