Two Dose Versus Five Dose of Sulphadoxine/Pyrimethamine for Malaria Chemo-Prophylaxis in Pregnancy in A Nigerian Sub-Rural Tertiary Hospital: A Randomized Controlled (Open Label) Trial

Authors: Momoh MO ,Iselanumhen AO,   Eifediyi RA, Jombo SE. Omorogbe FI


Malaria has been described as a disease of poverty and under development. It remains a complex and overwhelming health problem, with 300 to 500 million new cases and two to three million deaths per year. Ninety percent of all deaths attributable to malaria occur in Sub-Saharan Africa.  Frequency and severity of complication increase during pregnancy as a result of transient depression of cell mediated immunity. The World Health Organization (WHO) currently recommends a package of interventions for controlling malaria during pregnancy in areas with stable transmission of Plasmodium falciparum, which includes the use of insecticide treated nets (ITNs), the administration during pregnancy of at least two doses of intermittent preventive treatment (IPTp) with Suphadoxine- Pyrimethamine combination(S/P) after quickening and 4 (four) weeks later, and effective case management of malaria.  Ongoing observational studies monitoring IPTp effectiveness has shown that  in  areas of high S/P efficacy, 3 doses of S/P were more effective than 2 doses. It has been observed  that there is a dose-dependent association of S/P combination  with beneficial maternal and fetal outcome with more than two doses of S/P. Objective: This study compares the prevalence of placenta malaria parasitaemia on histological assessment in patients using 2 doses and 5 doses of prophylactic Suphadoxine/Pyrimethamine and obstetric outcome.This was a prospective single center two arms randomized controlled (open label) trial in Irrua Specialist Teaching Hospital (ISTH), Irrua from March to November,2015. 278 participants were randomized into two groups A and B (group A receives two doses and group B receives five doses).  Data was analyzed with SPSS 16 IBM. Statistical comparison was done using chi- square for categorical variables and multivariate analysis. The level of significance was accepted when P- value is equal to or less than 0.05 and confidence interval of 95%. Primary outcome measure was placenta tissue plasmodium parasitaemia. In this study 278 pregnant women were recruited and randomized into two groups A and B with 20.9 % drop out rate, hence 220 participant were analyzed out of which; 115(52.3%) for group A and 105(47.3%)for group B. There were no differences between monthly (5) S/P doses (n=105) and the standard two doses S/P regimen (n=115) in placenta malaria parasitaemia by histopathology (21.9% vs 26.3% X2= 0.439, P= 0.0508).There were also no differences in the mean values of placenta weight, cord PCV, fetal weight and maternal PCV in labour with placenta parasitaemia. However there was an inverse relationship between placenta parasiteamia with maternal parity, also rural dwellers have more placenta parasiteamia compared to urban dwellers. It has been concluded from study that two dose of Sulphadoxine Pyrimethamine for Intermittent Preventive Treatment is as efficacious as five doses of S/P regimen in prevention of malaria in pregnancy and adverse feto-maternal outcomes. There is need to provide sulphadoxine / pyrimethamine for all pregnant women free in a (unless contraindicated) free in directly observed therapy.


Sulphadoxine pyrimethamine, malaria prophylaxis, placenta parasitaemia.

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 Two Dose Versus Five Dose of Sulphadoxine/Pyrimethamine for Malaria Chemo-Prophylaxis in Pregnancy in A Nigerian Sub-Rural Tertiary Hospital: A Randomized Controlled (Open Label) Trial