SEARCHRCTobstetrics and gynecology, infectious disease

RCT·obstetrics and gynecology, infectious disease, pediatrics, epidemiology, clinical trial·PMC10077022

The Impact of Antenatal Azithromycin and Monthly Sulfadoxine-Pyrimethamine on Maternal Malaria during Pregnancy and Fetal Growth: A Randomized Controlled Trial

The American Journal of Tropical Medicine and Hygiene · 9 authors, 4 centres

AI SUMMARY

FIDELITY 100%

POPULATION1,320 pregnant Malawian women at 14–26 gestation weeks

INTERVENTIONMonthly sulfadoxine-pyrimethamine (SP) from enrollment until 37 weeks; or monthly SP plus two doses of azithromycin (AZI-SP)

COMPARISONTwo doses of sulfadoxine-pyrimethamine (control group)

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

This randomized controlled trial of 1,320 pregnant Malawian women found that monthly sulfadoxine-pyrimethamine (SP) with or without azithromycin significantly reduced the odds of maternal malaria parasitemia compared to a standard two-dose SP regimen. Neither intervention affected the growth velocity of fetal biparietal diameter or femur length.

Full summary

1,108 CHARS

This randomized controlled trial enrolled 1,320 pregnant Malawian women to compare three antenatal regimens: standard two-dose SP, monthly SP, or monthly SP plus azithromycin (AZI-SP). The primary aim was to assess the impact on maternal malaria parasitemia and fetal growth. Malaria parasitemia was diagnosed via PCR from dried blood spots, and fetal growth was assessed via ultrasound measurements of biparietal diameter and femur length in a subgroup. Results showed monthly SP reduced odds of malaria parasitemia in the third trimester (OR 0.58) and combined trimesters (OR 0.64) versus control. AZI-SP further reduced odds in the second (OR 0.47) and third trimesters (OR 0.51), with a combined OR of 0.50. Differences between the monthly SP and AZI-SP groups were not statistically significant. Neither intervention affected fetal biparietal diameter or femur length growth velocity. The study is strengthened by randomization and blinding but noted limitations include potential variation in measurement timing and the study not being powered to detect differences between the two intervention groups.

PICO

PPOPULATION

1,320 pregnant Malawian women at 14–26 gestation weeks

IINTERVENTION

Monthly sulfadoxine-pyrimethamine (SP) from enrollment until 37 weeks; or monthly SP plus two doses of azithromycin (AZI-SP)

OOUTCOME

Maternal PCR-diagnosed malaria parasitemia and fetal biparietal diameter and femur length growth velocity

STUDY TYPE

RCT

SPECIALTY

obstetrics and gynecology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10077022

The Impact of Antenatal Azithromycin and Monthly Sulfadoxine-Pyrimethamine on Maternal Malaria during Pregnancy and Fetal Growth: A Randomized Controlled Trial

The American Journal of Tropical Medicine and Hygiene

READ THE FULL PAPER

ABSTRACT

ABSTRACT. Maternal malaria and infections during pregnancy are risk factors for fetal growth restriction. We assessed the impact of preventive treatment in pregnancy on maternal malaria and fetal growth. Between 2003 and 2006, we enrolled 1,320 pregnant Malawian women, 14–26 gestation weeks, in a randomized trial and treated them with two doses of sulfadoxine-pyrimethamine (SP, control) at enrollment and between 28–34 gestation weeks; with monthly SP from enrollment until 37 gestation weeks; or with monthly SP and azithromycin twice, at enrollment and between 28 and 34 gestation weeks (AZI-SP). Participants were seen at 4-week intervals until 36 completed gestation weeks and weekly thereafter. At each visit, we collected dried blood spots for real-time polymerase chain reaction diagnosing of malaria parasitemia and, in a random subgroup of 341 women, we measured fetal biparietal diameter and femur length with ultrasound. For the monthly SP versus the control group, the odds ratios (OR) (95% CI) of malaria parasitemia during the second, third, and both trimesters combined were 0.79 (0.46–1.37), 0.58 (0.37–0.92), and 0.64 (0.42–0.98), respectively. The corresponding ORs for the AZI-SP versus control group were 0.47 (0.26–0.84), 0.51 (0.32–0.81), and 0.50 (0.32–0.76), respectively. Differences between the AZI-SP and the monthly SP groups were not statistically significant. The interventions did not affect fetal biparietal diameter and femur length growth velocity. The results suggest that preventive maternal treatment with monthly SP reduced malaria parasitemia during pregnancy in Malawi and that the addition of azithromycin did not provide much additional antimalarial effect.

CITATION EXPORT

Lotta Hallamaa, Per Ashorn, Yin Bun Cheung et al.. The Impact of Antenatal Azithromycin and Monthly Sulfadoxine-Pyrimethamine on Maternal Malaria during Pregnancy and Fetal Growth: A Randomized Controlled Trial. The American Journal of Tropical Medicine and Hygiene. (2023). https://doi.org/10.4269/ajtmh.22-0496

AUTHORS

9 · 4 CENTRES

Lotta Hallamaa, Per Ashorn, Yin Bun Cheung, Mari Luntamo, Ulla Ashorn, Teija Kulmala, Kenneth Maleta, Charles Mangani, Yue-Mei Fan

1Center for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland;
2Department of Pediatrics, Tampere University Hospital, Tampere, Finland;
3Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore;
4Department of Public Health, School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, Malawi