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

Malaria Journal

Table 6 Birth defects reported from time of delivery until 14 weeks after birth, according to anti-malarial drug exposure during the first trimester

	Exposure to anti-malarial(s) during first trimester
	AL only (N = 133)	AL plus SP (N = 7)	SP or/and quinine (N = 126)	None (N = 627)	Unknown (N = 40)
Total number of infants with malformations (%)	9/130 (6.9)	0/7 (-)	8/121 (6.6)	27/596 (4.5)	3/39 (7.7)
Umbilical hernia⁴	8 (6.2)	0 (-)	5 (4.1)	20 (3.4)	0 (-)
Polydactyly	0 (-)	0 (-)	1 (0.8)	4 (0.7)	2 (5.1)
Dermal cyst	0(-)	0 (-)	1 (0.8)	0 (-)	0 (-)
Ear malformation	0 (-)	0 (-)	1 (0.8)	0 (-)	0 (-)
Genitourinary system: small labia¹	1 (0.8)	0 (-)	0 (-)	0 (-)	0 (-)
Hair: lanugo¹	1 (0.8)	0 (-)	0 (-)	0 (-)	0 (-)
Inguinal hernia	0 (-)	0 (-)	0 (-)	1 (0.2)	0 (-)
Limbs: hyperextensibility of joint	0 (-)	0 (-)	0 (-)	0 (-)	1 (2.6)
Nose: small¹	1 (0.8)	0 (-)	0 (-)	0 (-)	0 (-)
Skin hyperpigmentation	0 (-)	0 (-)	0 (-)	1 (0.2)	0 (-)
Trisomy 18²	0 (-)	0 (-)	0 (-)	1 (0.2)	0 (-)
Trisomy 21³	0 (-)	0 (-)	0 (-)	1 (0.2)	0 (-)

Enrolled population: newborns.
¹ All of these malformations were reported in the same patient.
² Reported malformations in this patient: Ears - low set; Mouth - high arched palate; Cranium microencephaly/anencephaly; Limbs - clenched with overlapping fingers.
³ Reported malformations in this patient: Ears - low set; Mouth - high arched palate; CVS murmur; Chest - short sternum; Cranium: flat occiput; Eyes - upward slanting; Mouth: protruding tongue; Neck - short; Nose - low nasal bridge.
⁴ No umbilical hernia was detected at birth. Of 21 cases reported in the AL exposure group, 12 detected at week 6 were resolved by week 14. All remaining umbilical hernias had resolved by 12 months except for one infant who died prior to 12 months from a febrile illness. The mother of one infant with an umbilical hernia had received quinine during the first trimester of pregnancy, before AL treatment of the index episode (not in the first trimester) and another had received SP during the first trimester. In eight additional cases, the mother had received AL treatment in the first trimester, in each case to treat the index episode of malaria. In the SP group, among 12 infants with umbilical hernias, 7 had resolved by week 14, the remainder by month 12, with the exception of 1 case lost to follow-up, and one infant who died from pneumonia.

ISSN: 1475-2875