Artemisinin-based combination therapy during pregnancy

Outcome of pregnancy and infant mortality: A cohort study

Michael Nambozi, Halidou Tinto, Victor Mwapasa, Harry Tagbor, Jean Bertin Bukasa Kabuya, Sebastian Hachizovu, Maminata Traoré, Innocent Valea, Marc Christian Tahita, Gifty Ampofo, Jozefien Buyze, Raffaella Ravinetto, Diana Arango, Kamala Thriemer, Modest Mulenga, Jean Pierre Van Geertruyden, Umberto D'Alessandro

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    Abstract

    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. 

    Original languageEnglish
    Article number105
    Pages (from-to)1-8
    Number of pages8
    JournalMalaria Journal
    Volume18
    DOIs
    Publication statusPublished - 28 Mar 2019

    Fingerprint

    Infant Mortality
    Pregnancy Outcome
    Cohort Studies
    Malaria
    Mefloquine
    Pregnancy
    dihydroartemisinin
    Third Pregnancy Trimester
    Second Pregnancy Trimester
    Burkina Faso
    Zambia
    Malawi
    Ghana
    Perinatal Mortality
    Low Birth Weight Infant
    Therapeutics
    Marketing
    Pregnant Women
    Safety
    artemisinine

    Cite this

    Nambozi, M., Tinto, H., Mwapasa, V., Tagbor, H., Kabuya, J. B. B., Hachizovu, S., ... D'Alessandro, U. (2019). Artemisinin-based combination therapy during pregnancy: Outcome of pregnancy and infant mortality: A cohort study. Malaria Journal, 18, 1-8. [105]. https://doi.org/10.1186/s12936-019-2737-7
    Nambozi, Michael ; Tinto, Halidou ; Mwapasa, Victor ; Tagbor, Harry ; Kabuya, Jean Bertin Bukasa ; Hachizovu, Sebastian ; Traoré, Maminata ; Valea, Innocent ; Tahita, Marc Christian ; Ampofo, Gifty ; Buyze, Jozefien ; Ravinetto, Raffaella ; Arango, Diana ; Thriemer, Kamala ; Mulenga, Modest ; Van Geertruyden, Jean Pierre ; D'Alessandro, Umberto. / Artemisinin-based combination therapy during pregnancy : Outcome of pregnancy and infant mortality: A cohort study. In: Malaria Journal. 2019 ; Vol. 18. pp. 1-8.
    @article{07c7a0c80b194ce19f6fedf4bc6fa775,
    title = "Artemisinin-based combination therapy during pregnancy: Outcome of pregnancy and infant mortality: A cohort study",
    abstract = "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. ",
    author = "Michael Nambozi and Halidou Tinto and Victor Mwapasa and Harry Tagbor and Kabuya, {Jean Bertin Bukasa} and Sebastian Hachizovu and Maminata Traor{\'e} and Innocent Valea and Tahita, {Marc Christian} and Gifty Ampofo and Jozefien Buyze and Raffaella Ravinetto and Diana Arango and Kamala Thriemer and Modest Mulenga and {Van Geertruyden}, {Jean Pierre} and Umberto D'Alessandro",
    year = "2019",
    month = "3",
    day = "28",
    doi = "10.1186/s12936-019-2737-7",
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    Nambozi, M, Tinto, H, Mwapasa, V, Tagbor, H, Kabuya, JBB, Hachizovu, S, Traoré, M, Valea, I, Tahita, MC, Ampofo, G, Buyze, J, Ravinetto, R, Arango, D, Thriemer, K, Mulenga, M, Van Geertruyden, JP & D'Alessandro, U 2019, 'Artemisinin-based combination therapy during pregnancy: Outcome of pregnancy and infant mortality: A cohort study', Malaria Journal, vol. 18, 105, pp. 1-8. https://doi.org/10.1186/s12936-019-2737-7

    Artemisinin-based combination therapy during pregnancy : Outcome of pregnancy and infant mortality: A cohort study. / Nambozi, Michael; Tinto, Halidou; Mwapasa, Victor; Tagbor, Harry; Kabuya, Jean Bertin Bukasa; Hachizovu, Sebastian; Traoré, Maminata; Valea, Innocent; Tahita, Marc Christian; Ampofo, Gifty; Buyze, Jozefien; Ravinetto, Raffaella; Arango, Diana; Thriemer, Kamala; Mulenga, Modest; Van Geertruyden, Jean Pierre; D'Alessandro, Umberto.

    In: Malaria Journal, Vol. 18, 105, 28.03.2019, p. 1-8.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Artemisinin-based combination therapy during pregnancy

    T2 - 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, Diana

    AU - Thriemer, Kamala

    AU - Mulenga, Modest

    AU - Van Geertruyden, Jean Pierre

    AU - D'Alessandro, Umberto

    PY - 2019/3/28

    Y1 - 2019/3/28

    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. 

    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. 

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    U2 - 10.1186/s12936-019-2737-7

    DO - 10.1186/s12936-019-2737-7

    M3 - Article

    VL - 18

    SP - 1

    EP - 8

    JO - Malaria Journal

    JF - Malaria Journal

    SN - 1475-2875

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