Comparative efficacy of uncontrolled and controlled intermittent preventive treatment during pregnancy (IPTp) with combined use of LLTNs in high resistance area to sulfadoxine-pyrimethamine in Côte d’Ivoire

Abstract

Introduction

In recent years, intermittent preventive treatment for pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) has become policy in much of sub-Saharan Africa. But resistance to SP has been spreading across sub-Saharan Africa and thus the effectiveness of IPTp-SP has been questioned. The present study therefore sought to assess the incidence of placental malaria, low birth weight, and anemia of two IPTp-SP approaches (directly observed treatment scheme versus no directly observed treatment) in Anonkoua-Kouté and Samo, Côte d’Ivoire where the reported prevalence of dfr single mutant 108 was 62% and 52.2%, respectively.

Methods

The study was a longitudinal design involving pregnant women and was conducted in Anonkoua-Kouté, a suburban area, and Samo, a rural area, from January 2008 through March 2009. Women of a pregnancy less than 28 weeks duration were randomized to receive SP (1.5 g/0.075 g SP) in a single intake twice and were followed up monthly until delivery. Doses were administered under supervision in the controlled IPTp group, while SP was given free to women in the uncontrolled IPTp group with a recommendation to take it at home. The primary end point was the proportion of low birth weight infants (body weight < 2500 g) and the secondary end point was the rate of severe anemia and placental malaria detected at delivery.

Results

A total of 420 pregnant women were enrolled (212 and 208, respectively, in the controlled and uncontrolled groups). Delivery outcome was available for 378 women. In the modified intention-to-treat analysis, low birth weight infants were born from 15.5% of women of the uncontrolled IPTp group and from 11.9% of women in the controlled IPTp group (P = 0.31). The per-protocol population analysis showed consistent results. The proportion of women with placental malaria infection, moderate anemia (hemoglobin < 11 g/dL), and severe anemia (hemoglobin < 8 g/dL) at delivery were similar between the two groups (P > 0.05).

Conclusion

The study showed that the two approaches were equivalent, suggesting that unsupervised IPTp-SP free of charge should be used in areas where implementation of the directly observed treatment scheme suffers from many constraints.

Keywords:

• IPTp
• SP efficacy
• DOT scheme
• resistance
• Côte d’Ivoire

Acknowledgments

The authors are grateful to the women who participated in the study and medical staff, particularly the midwives of Anonkoua- Kouté and Samo maternities. The authors would also like to acknowledge the contributions of Dr Man-Koumba Soumahoro for the multivariable analysis, Mr Ghiorghis Belai for revision of the manuscript, and Mrs Gbaguidi Martin and Kobenan Kra who undertook central reading of the slides. The authors thank the Pasteur Institute Malaria Network for financial support.

Disclosure

The authors report no conflicts of interest in this work. All authors participated in design, implementation, analysis, or interpretation of the study. OAT was involved in all phases of the study and had full access to all the data in the study. LKP, JR, and KM participated in the design and supervised the study. CMA, NTL, AABA, AE, CB, and KD were responsible for conduction of field studies and coordination of study procedures. SD was involved in the design and the statistical analysis of data. The manuscript was drafted by OAT; substantial input came from all investigators. All authors critically reviewed the report and approved the final version of the report for submission.