Effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine-pyrimethamine for the prevention of low birth weight in Burkina Faso: an open-label randomized controlled trial
Abstract Background Exposure during pregnancy to malaria and sexually-transmitted infections is associated with adverse birth outcomes including low birth weight (LBW). This study aimed at assessing if the adjunction of two doses of azithromycin to sulfadoxine-pyrimethamine for the intermittent prev...
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BMC
2023-03-01
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| Series: | Malaria Journal |
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| Online Access: | https://doi.org/10.1186/s12936-023-04530-5 |
| _version_ | 1797865562906296320 |
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| author | Moussa Lingani Serge H. Zango Innocent Valéa Sékou Samadoulougou Georges Somé Maïmouna Sanou Berenger Kaboré Toussaint Rouamba Herman Sorgho Marc C. Tahita Karim Derra Michèle Dramaix Halidou Tinto Philippe Donnen Annie Robert |
| author_facet | Moussa Lingani Serge H. Zango Innocent Valéa Sékou Samadoulougou Georges Somé Maïmouna Sanou Berenger Kaboré Toussaint Rouamba Herman Sorgho Marc C. Tahita Karim Derra Michèle Dramaix Halidou Tinto Philippe Donnen Annie Robert |
| author_sort | Moussa Lingani |
| collection | DOAJ |
| description | Abstract Background Exposure during pregnancy to malaria and sexually-transmitted infections is associated with adverse birth outcomes including low birth weight (LBW). This study aimed at assessing if the adjunction of two doses of azithromycin to sulfadoxine-pyrimethamine for the intermittent preventive treatment of malaria in pregnancy can reduce LBW. Methods A two parallel-groups, open-label randomized controlled trial involving pregnant women (16 to 35 years of age and 12 to 24 weeks of gestation as confirmed by last menstrual period or fundal height) was conducted in rural Burkina Faso. Women were assigned in a 1:1 ratio either to use azithromycin (1 g daily for 2 days) during the second and third trimesters of pregnancy plus monthly sulfadoxine-pyrimethamine (1500/75 mg) (SPAZ) (intervention) or to continue using a monthly sulfadoxine-pyrimethamine (1500/75 mg) (SP) (control). Primary outcome was a LBW (birth weight measured within 24 h after birth < 2500 g). Secondary outcomes including stillbirth, preterm birth or miscarriage are reported together with safety data. Results A total of 992 pregnant women underwent randomization (496 per group) and 898 (90.5%) valid birth weights were available (450 in SPAZ and 448 in SP). LBW incidence was 8.7% (39/450) in SPAZ and 9.4% (42/448) in controls (p-value = 0.79). Compared with controls, pregnant women with SPAZ showed a risk ratio (RR) of 1.16 (95% confidence interval (CI 0.64–2.08]) for preterm births, 0.75 (95% CI 0.17–3.35) for miscarriage and 0.64 (95% CI 0.25–1.64) for stillbirths. No treatment-related serious adverse events (SAEs) have been observed, and there was no significant difference in the number of SAEs (13.5% [67/496] in SPAZ, 16.7% [83/496] in SP, p-value = 0.18) or AEs (17.1% [85/496] in SPAZ, 18.8% [93/496] in SP, p-value = 0.56). Conclusion Adequate prevention regimen with monthly sulfadoxine-pyrimethamine given to all pregnant women has been proved to reduce the risk of LBW in malaria endemic areas. Adding azithromycin to the regimen does not offer further benefits, as far as women receive a malaria prevention regimen early enough during pregnancy. Trial registration Pan African Clinical Trial Registry ( https://pactr.samrc.ac.za/Search.aspx ): PACTR201808177464681. Registered 21 August 2018. |
| first_indexed | 2024-04-09T23:10:05Z |
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| id | doaj.art-c399a5f047784069bc160d6446611acb |
| institution | Directory Open Access Journal |
| issn | 1475-2875 |
| language | English |
| last_indexed | 2024-04-09T23:10:05Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Malaria Journal |
| spelling | doaj.art-c399a5f047784069bc160d6446611acb2023-03-22T10:29:08ZengBMCMalaria Journal1475-28752023-03-012211910.1186/s12936-023-04530-5Effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine-pyrimethamine for the prevention of low birth weight in Burkina Faso: an open-label randomized controlled trialMoussa Lingani0Serge H. Zango1Innocent Valéa2Sékou Samadoulougou3Georges Somé4Maïmouna Sanou5Berenger Kaboré6Toussaint Rouamba7Herman Sorgho8Marc C. Tahita9Karim Derra10Michèle Dramaix11Halidou Tinto12Philippe Donnen13Annie Robert14Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)Evaluation Platform On Obesity Prevention, Quebec Heart and Lung Institute Research CenterInstitut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)École de Santé Publique, Université Libre de Bruxelles. CP594Institut de Recherche en Sciences de La Santé/Direction Régionale du Centre Ouest (IRSS/DRCO)École de Santé Publique, Université Libre de Bruxelles. CP594Epidemiology and Biostatistics Research Division, Institut de Recherche Expérimentale Et Clinique, Université Catholique de LouvainAbstract Background Exposure during pregnancy to malaria and sexually-transmitted infections is associated with adverse birth outcomes including low birth weight (LBW). This study aimed at assessing if the adjunction of two doses of azithromycin to sulfadoxine-pyrimethamine for the intermittent preventive treatment of malaria in pregnancy can reduce LBW. Methods A two parallel-groups, open-label randomized controlled trial involving pregnant women (16 to 35 years of age and 12 to 24 weeks of gestation as confirmed by last menstrual period or fundal height) was conducted in rural Burkina Faso. Women were assigned in a 1:1 ratio either to use azithromycin (1 g daily for 2 days) during the second and third trimesters of pregnancy plus monthly sulfadoxine-pyrimethamine (1500/75 mg) (SPAZ) (intervention) or to continue using a monthly sulfadoxine-pyrimethamine (1500/75 mg) (SP) (control). Primary outcome was a LBW (birth weight measured within 24 h after birth < 2500 g). Secondary outcomes including stillbirth, preterm birth or miscarriage are reported together with safety data. Results A total of 992 pregnant women underwent randomization (496 per group) and 898 (90.5%) valid birth weights were available (450 in SPAZ and 448 in SP). LBW incidence was 8.7% (39/450) in SPAZ and 9.4% (42/448) in controls (p-value = 0.79). Compared with controls, pregnant women with SPAZ showed a risk ratio (RR) of 1.16 (95% confidence interval (CI 0.64–2.08]) for preterm births, 0.75 (95% CI 0.17–3.35) for miscarriage and 0.64 (95% CI 0.25–1.64) for stillbirths. No treatment-related serious adverse events (SAEs) have been observed, and there was no significant difference in the number of SAEs (13.5% [67/496] in SPAZ, 16.7% [83/496] in SP, p-value = 0.18) or AEs (17.1% [85/496] in SPAZ, 18.8% [93/496] in SP, p-value = 0.56). Conclusion Adequate prevention regimen with monthly sulfadoxine-pyrimethamine given to all pregnant women has been proved to reduce the risk of LBW in malaria endemic areas. Adding azithromycin to the regimen does not offer further benefits, as far as women receive a malaria prevention regimen early enough during pregnancy. Trial registration Pan African Clinical Trial Registry ( https://pactr.samrc.ac.za/Search.aspx ): PACTR201808177464681. Registered 21 August 2018.https://doi.org/10.1186/s12936-023-04530-5Low birth weightMiscarriageStillbirthPreterm birthSulfadoxine-pyrimethamineAzithromycin |
| spellingShingle | Moussa Lingani Serge H. Zango Innocent Valéa Sékou Samadoulougou Georges Somé Maïmouna Sanou Berenger Kaboré Toussaint Rouamba Herman Sorgho Marc C. Tahita Karim Derra Michèle Dramaix Halidou Tinto Philippe Donnen Annie Robert Effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine-pyrimethamine for the prevention of low birth weight in Burkina Faso: an open-label randomized controlled trial Malaria Journal Low birth weight Miscarriage Stillbirth Preterm birth Sulfadoxine-pyrimethamine Azithromycin |
| title | Effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine-pyrimethamine for the prevention of low birth weight in Burkina Faso: an open-label randomized controlled trial |
| title_full | Effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine-pyrimethamine for the prevention of low birth weight in Burkina Faso: an open-label randomized controlled trial |
| title_fullStr | Effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine-pyrimethamine for the prevention of low birth weight in Burkina Faso: an open-label randomized controlled trial |
| title_full_unstemmed | Effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine-pyrimethamine for the prevention of low birth weight in Burkina Faso: an open-label randomized controlled trial |
| title_short | Effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine-pyrimethamine for the prevention of low birth weight in Burkina Faso: an open-label randomized controlled trial |
| title_sort | effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine pyrimethamine for the prevention of low birth weight in burkina faso an open label randomized controlled trial |
| topic | Low birth weight Miscarriage Stillbirth Preterm birth Sulfadoxine-pyrimethamine Azithromycin |
| url | https://doi.org/10.1186/s12936-023-04530-5 |
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