Lungwena Antenatal Intervention Study (LAIS) is a randomized, three-arm parallel-group investigator-blinded clinical trial that primarily aimed to assess the impact of intensive presumptive treatment of maternal malaria and reproductive tract infection on the incidence of preterm delivery and associated ill health. The original study hypothesis was that maternal antibiotic treatment with monthly sulphadoxine-pyrimethamine, alone or in combination with two doses of azithromycin, improves foetal growth and decreases the incidence of preterm delivery, thus leading to an increased infant size at birth and at one month of age. The primary efficacy and safety outcome measures were the incidence of preterm delivery and serious adverse events, main secondary outcomes mean newborn size (weight, length, MUAC, head circumference) at birth and at 28 days of age as well as prevalence of underweight, stunting and wasting at the age of 28 days.
A total of 1320 pregnant women were enrolled to the study and followed through pregnancy. Delivery events and birth weights were recorded on a home visit soon after delivery. Child growth and health was monitored at 3-monthly clinic visits up to 24 months, and then at 30, 36, 48 and 60 months of child age. The results on the pregnancy outcomes, as well as studies on malaria immunity and parasite antibiotic resistance have been published in international journals (Luntamo et al. 2010, Luntamo et at., 2012; Luntamo et al, 2013). At present, we are analyzing the impact of the intervention on the children’s growth, morbidity, development and mortality in their first five years of age.
- Videman K, Hallamaa L, Heimonen O, Mangani C, Luntamo M, Maleta K, Ashorn P, Ashorn U. Child growth and neurodevelopment after maternal antenatal antibiotic treatment. Arch Dis Child. 2021 Sep 3:archdischild-2021-322043. doi: 10.1136/archdischild-2021-322043. Epub ahead of print.
- Hallamaa L, Cheung YB, Luntamo M, Ashorn U, Kulmala T, Mangani C, Ashorn P. The impact of maternal antenatal treatment with two doses of azithromycin and monthly sulphadoxine-pyrimethamine on child weight, mid-upper arm circumference and head circumference: A randomized controlled trial. PLoS One. 2019 May 7;14(5):e0216536. doi: 10.1371/journal.pone.0216536. eCollection 2019.
- Hallamaa L, Cheung YB, Maleta K, Luntamo M, Ashorn U, Gladstone M, Kulmala T, Mangani C, Ashorn P. Child Health Outcomes After Presumptive Infection Treatment in Pregnant Women: A Randomized Trial. Pediatrics. 2018 Mar;141(3). pii: e20172459. doi: 10.1542/peds.2017-2459.
- Ashorn P, Vanhala H, Pakarinen O, Ashorn U, De Costa A. Prevention of Intrauterine Growth Restriction and Preterm Birth with Presumptive Antibiotic Treatment of Pregnant Women: A Literature Review. Nestle Nutr Inst Workshop Ser. 2015;81:37-50.
- Xu J, Luntamo M, Kulmala T, Ashorn P, Cheung YB. A longitudinal study of weight gain in pregnancy in Malawi: unconditional and conditional standards. Am J Clin Nutr. 2014 Feb;99(2):296-301.
- Luntamo M, Kulmala T, Cheung YB, Maleta K, Ashorn P. The effect of antenatal monthly sulphadoxine-pyrimethamine, alone or with azithromycin, on foetal and neonatal growth faltering in Malawi: a randomised controlled trial. Trop Med Int Health. 2013 Apr;18(4):386-97.
- Kayentao K, Garner P, van Eijk AM, Naidoo I, Roper C, Mulokozi A, MacArthur JR, Luntamo M, Ashorn P, Doumbo OK, ter Kuile FO. Intermittent preventive therapy for malaria during pregnancy using 2 vs 3 or more doses of sulfadoxine-pyrimethamine and risk of low birth weight in Africa: systematic review and meta-analysis. JAMA. 2013 Feb 13;309(6):594-604.
- Lin JT, Mbewe B, Taylor SM, Luntamo M, Meshnick SR, Ashorn P. Increased prevalence of dhfr and dhps mutants at delivery in Malawian pregnant women receiving intermittent preventive treatment for malaria. Trop Med Int Health. 2013 Feb;18(2):175-8.
- Luntamo M, Rantala AM, Meshnick SR, Cheung YB, Kulmala T, Maleta K, Ashorn P. The effect of monthly sulfadoxine-pyrimethamine, alone or with azithromycin, on PCR-diagnosed malaria at delivery: a randomized controlled trial. PLoS One. 2012;7(7):e41123.
- Aitken EH, Mbewe B, Luntamo M, Kulmala T, Beeson JG, Ashorn P, Rogerson SJ. Antibody to P. falciparum in pregnancy varies with intermittent preventive treatment regime and bed net use. PLoS One. 2012;7(1):e29874.
- Luntamo M, Kulmala T, Mbewe B, Cheung YB, Maleta K, Ashorn P. Effect of repeated treatment of pregnant women with sulfadoxine-pyrimethamine and azithromycin on preterm delivery in Malawi: a randomized controlled trial. Am J Trop Med Hyg. 2010 Dec;83(6):1212-20.
- Rantala AM, Taylor SM, Trottman PA, Luntamo M, Mbewe B, Maleta K, Kulmala T, Ashorn P, Meshnick SR. Comparison of real-time PCR and microscopy for malaria parasite detection in Malawian pregnant women. Malar J. 2010 Oct 6;9:269.
- Aitken EH, Mbewe B, Luntamo M, Maleta K, Kulmala T, Friso MJ, Fowkes FJ, Beeson JG, Ashorn P, Rogerson SJ. Antibodies to chondroitin sulfate A-binding infected erythrocytes: dynamics and protection during pregnancy in women receiving intermittent preventive treatment. J Infect Dis. 2010 May 1;201(9):1316-25.