TY - JOUR
T1 - Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study
AU - Nambozi, Michael
AU - Tinto, Halidou
AU - Mwapasa, Victor
AU - Tagbor, Harry
AU - Kabuya, Jean-Bertin Bukasa
AU - Hachizovu, Sebastian
AU - Traoré, Maminata
AU - Valea, Innocent
AU - Tahita, Marc Christian
AU - Ampofo, Gifty
AU - Buyze, Jozefien
AU - Ravinetto, Raffaella
AU - Arango Jimenez, Diana
AU - Thriemer, Kamala
AU - Mulenga, Modest
AU - van Geertruyden, Jean-Pierre
AU - D'Alessandro, Umberto
N1 - FTX; DOAJ; CINTEXT; (CC BY 4.0)
PY - 2019
Y1 - 2019
N2 - Background: The World Health Organization (WHO) recommendation of treating uncomplicated malaria during the second and third trimester of pregnancy with an artemisinin-based combination therapy (ACT) has already been implemented by all sub-Saharan African countries. However, there is limited knowledge on the effect of ACT on pregnancy outcomes, and on newborn and infant's health.Methods: Pregnant women with malaria in four countries (Burkina Faso, Ghana, Malawi and Zambia) were treated with either artemether-lumefantrine (AL), amodiaquine-artesunate (ASAQ), mefloquine-artesunate (MQAS), or dihydroartemisinin-piperaquine (DHA-PQ); 3127 live new-borns (822 in the AL, 775 in the ASAQ, 765 in the MQAS and 765 in the DHAPQ arms) were followed-up until their first birthday.Results: Prevalence of placental malaria and low birth weight were 28.0% (738/2646) and 16.0% (480/2999), respectively, with no significant differences between treatment arms. No differences in congenital malformations (p = 0.35), perinatal mortality (p = 0.77), neonatal mortality (p = 0.21), and infant mortality (p = 0.96) were found.Conclusions: Outcome of pregnancy and infant survival were similar between treatment arms indicating that any of the four artemisinin-based combinations could be safely used during the second and third trimester of pregnancy without any adverse effect on the baby. Nevertheless, smaller safety differences between artemisinin-based combinations cannot be excluded; country-wide post-marketing surveillance would be very helpful to confirm such findings. Trial registration ClinicalTrials.gov, NCT00852423, Registered on 27 February 2009, https://clinicaltrials.gov/ct2/show/NCT00852423.
AB - Background: The World Health Organization (WHO) recommendation of treating uncomplicated malaria during the second and third trimester of pregnancy with an artemisinin-based combination therapy (ACT) has already been implemented by all sub-Saharan African countries. However, there is limited knowledge on the effect of ACT on pregnancy outcomes, and on newborn and infant's health.Methods: Pregnant women with malaria in four countries (Burkina Faso, Ghana, Malawi and Zambia) were treated with either artemether-lumefantrine (AL), amodiaquine-artesunate (ASAQ), mefloquine-artesunate (MQAS), or dihydroartemisinin-piperaquine (DHA-PQ); 3127 live new-borns (822 in the AL, 775 in the ASAQ, 765 in the MQAS and 765 in the DHAPQ arms) were followed-up until their first birthday.Results: Prevalence of placental malaria and low birth weight were 28.0% (738/2646) and 16.0% (480/2999), respectively, with no significant differences between treatment arms. No differences in congenital malformations (p = 0.35), perinatal mortality (p = 0.77), neonatal mortality (p = 0.21), and infant mortality (p = 0.96) were found.Conclusions: Outcome of pregnancy and infant survival were similar between treatment arms indicating that any of the four artemisinin-based combinations could be safely used during the second and third trimester of pregnancy without any adverse effect on the baby. Nevertheless, smaller safety differences between artemisinin-based combinations cannot be excluded; country-wide post-marketing surveillance would be very helpful to confirm such findings. Trial registration ClinicalTrials.gov, NCT00852423, Registered on 27 February 2009, https://clinicaltrials.gov/ct2/show/NCT00852423.
KW - ARTESUNATE
KW - BURDEN
KW - DIHYDROARTEMISININ-PIPERAQUINE
KW - FALCIPARUM-MALARIA
KW - INTERMITTENT PREVENTIVE TREATMENT
KW - MEFLOQUINE
KW - OPEN-LABEL
KW - QUININE
KW - SULFADOXINE-PYRIMETHAMINE
KW - WOMEN
U2 - 10.1186/s12936-019-2737-7
DO - 10.1186/s12936-019-2737-7
M3 - A1: Web of Science-article
C2 - 30922317
SN - 1475-2875
VL - 18
JO - Malaria Journal
JF - Malaria Journal
IS - 1
M1 - 105
ER -