Artemisinin-based combination therapy during pregnancy: outcome of pregnancy and infant mortality: a cohort study.
Adolescent
Adult
Africa South of the Sahara
Antimalarials
/ administration & dosage
Artemisinins
/ administration & dosage
Cohort Studies
Drug Therapy, Combination
/ methods
Female
Follow-Up Studies
Humans
Infant
Infant Mortality
Infant, Newborn
Malaria
/ drug therapy
Pregnancy
Pregnancy Complications, Infectious
/ drug therapy
Pregnancy Outcome
Young Adult
Journal
Malaria journal
ISSN: 1475-2875
Titre abrégé: Malar J
Pays: England
ID NLM: 101139802
Informations de publication
Date de publication:
28 Mar 2019
28 Mar 2019
Historique:
received:
02
08
2018
accepted:
20
03
2019
entrez:
30
3
2019
pubmed:
30
3
2019
medline:
30
4
2019
Statut:
epublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 30922317
doi: 10.1186/s12936-019-2737-7
pii: 10.1186/s12936-019-2737-7
pmc: PMC6437904
doi:
Substances chimiques
Antimalarials
0
Artemisinins
0
artemisinin
9RMU91N5K2
Banques de données
ClinicalTrials.gov
['NCT00852423']
Types de publication
Clinical Trial
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
105Subventions
Organisme : European and Developing Countries Clinical Trials Partnership
ID : IP.2007.31080.001
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