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Proguanil Versus Sulphadoxine-Pyrimethamine for Malaria Chemoprophylaxis in Pregnancy: a Randomised Controlled Trial

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Proguanil Versus Sulphadoxine-Pyrimethamine for Malaria Chemoprophylaxis in Pregnancy: a Randomised Controlled Trial Clin l of ica Kasso et al., J Clin Trials 2012, 2:4 a l T n r r i u a DOI: 10.4172/2167-0870.1000122 l o s J Journal of Clinical Trials ISSN: 2167-0870 Research Article Open Access Proguanil versus Sulphadoxine-Pyrimethamine for Malaria Chemoprophylaxis in Pregnancy: A Randomised Controlled Trial Terhemen Kasso1, Israel Jeremiah2* and Celestine T John1 1Department of Obstetrics and Gynaecology, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria 2Department of Obstetrics and Gynaecology, Niger Delta University, Amassoma, Nigeria Abstract Background: Malaria is a leading cause of maternal and perinatal morbidity and mortality in sub Saharan Africa. Intermittent Preventive Treatment (IPT) with Sulphadoxine-Pyrimethamine (SP) has been proven efficacious in reducing the burden of malaria in pregnancy. However its use is contraindicated in some individuals and malaria resistance to SP has been reported. Therefore there is a need to seek for effective alternatives. This study sought to compare the effectiveness of proguanil versus SP for malaria chemoprophylaxis in pregnancy. Methodology: This was a randomised controlled trial of women attending antenatal clinic at the University of Port Harcourt Teaching Hospital, Nigeria from January 2010 to September 2010. Three hundred and fifty participants were recruited at booking, randomized into two groups using a table of random numbers and monitored till delivery. One group received daily proguanil while the other received SP for malaria prophylaxis. Blood samples were taken for their haematocrit and malaria parasites at booking and delivery. The results were compared. Data management was with SPSS 15 for Windows® statistical soft ware. A p-value of less than 0.05 was considered statistically significant. Results: The prevalence of maternal malaria parasitaemia in this study was 29.9% at booking and 12.5% at delivery. The prevalence at delivery in women given SP and proguanil was 10.6% and 14.4% respectively. This was not statistically significant (P=0.429). There was no statistical difference in the incidence of preterm delivery (P=0.262), cord blood parasitaemia (P=0.385), low birth weight (P=0.175) and birth asphyxia (P=0.367) between the two study groups. Conclusion: There was no significant difference between intermittent preventive treatment with sulphadoxine- pyrimethamine and the use of daily proguanil so larger studies with proguanil are warranted. Keywords: Malaria; Chemoprophylaxis; Pregnancy; Proguanil; Control of malaria during pregnancy depends on both preventing Sulphadoxine-Pyrimethamine (SP) infection and clearing parasitaemia when it occurs [1]. This is because most women in areas of stable malaria transmission may not Introduction experience serious clinical illness. The WHO therefore recommends The World Health Organisation (WHO) estimates annually the the use of Insecticide-Treated Bed Nets (ITNs), Intermittent global incidence of malaria to be about 300 million cases. Malaria Preventive Treatment In Pregnancy (IPTp) and effective case is also estimated to kill between 1.1 to 2.7 million people worldwide management and treatment of malaria as interventions to prevent each year [1,2]. More than 90% of these deaths are from sub-Saharan this disease in pregnancy [9,10]. Intermittent preventive treatment Africa [1-3]. Over 50 million women are exposed to the risk of malaria with Sulphadoxine-Pyrimethamine (SP-IPT) had proven efficacious every year. Pregnant women are more susceptible to malaria than non in reducing the burden of malaria in pregnancy [11]. It is currently pregnant ones and this susceptibility is greatest in first and second the recommended regimen for prevention of malaria in pregnancy in pregnancies. Pregnancy complicated by malaria infection results in endemic areas. Sulphadoxine-pyrimethamine has been shown to be the substantial maternal, fetal and infant morbidity and mortality, causing most effective single dose anti-malarial drug for prevention of malaria 75,000-200,000 infant deaths every year [4,5]. Successful control of during pregnancy in areas where the strain of plasmodium remains malaria in pregnancy might therefore prevent these deaths. sensitive to it [12]. Current scientific evidence suggests that at least two doses of IPT are required to achieve optimal benefit in most women. In all malarious areas, infection by any of the plasmodium species The effectiveness of this drug is recently being threatened by during pregnancy is detrimental to the mother and the fetus. The most increasing levels of resistance to SP across Africa [13] and South East deleterious effects on the mother are caused by plasmodium falciparum Asia [14]. There is therefore need to develop alternative drug regimens [6]. Millions of pregnant women are exposed to malaria and thousands die every year as a result of direct or indirect consequence [6]. Both plasmodium falciparum and plasmodium vivax can cause *Corresponding author: Israel Jeremiah, Department of Obstetrics and adverse pregnancy outcomes, including maternal anaemia and low birth Gynaecology, Niger Delta University, Amassoma, Nigeria, Tel: +23-4803-5009- weight due to preterm delivery and intrauterine growth restriction [7]. 8348; E-mail: [email protected] Malaria causes and worsens anaemia in pregnancy, increased uterine Received April 22, 2012; Accepted August 27, 2012; Published August 31, 2012 activity, abortions and preterm labour [2]. Its effect on the fetus can Citation: Kasso T, Jeremiah I, John CT (2012) Proguanil versus Sulphadoxine- lead to abortions, IUGR (Intrauterine growth restriction), LBW (Low Pyrimethamine for Malaria Chemoprophylaxis in Pregnancy: A Randomised Birth Weight), severe birth asphyxia, congenital/neonatal malaria, Controlled Trial. J Clin Trials 2:122. doi:10.4172/2167-0870.1000122 hypoglycaemia and intrauterine fetal death. Cord blood parasitaemia Copyright: © 2012 Kasso T, et al. This is an open-access article distributed under may be present where placental malaria has been active at the time of the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and delivery [8]. source are credited. J Clin Trials Volume 2 • Issue 4 • 1000122 ISSN: 2167-0870 JCTR, an open access journal Citation: Kasso T, Jeremiah I, John CT (2012) Proguanil versus Sulphadoxine-Pyrimethamine for Malaria Chemoprophylaxis in Pregnancy: A Randomised Controlled Trial. J Clin Trials 2:122. doi:10.4172/2167-0870.1000122 Page 2 of 6 for IPT in pregnancy. Proguanil is considered as one of the safest anti- 2(1.96)2 x 0.24 ()1 – 0.24 ′= × malarials currently available [15-17] and has been used extensively n 2 1 4 0 for malaria chemoprophylaxis in pregnant women. Proguanil is well 0.10 tolerated and effective in all trimesters of pregnancy [16]. However, the Thus 140 experimental subjects and another 140 control subjects daily dosing of proguanil raises the problem of client compliance. were required for the study. This gave a total of 280 subjects which was rounded up to 300. However, 350 clients were recruited for the study Resistance to sulphadoxine-pyrimethamine is increasing, but with each arm having 175 subjects. This over sampling was deliberate evidence-based alternatives for IPTp have not yet been determined. In for drop out and loss to follow up. An average of 170 women booked women with contraindications to SP, proguanil is widely used as an for antenatal care per week at UPTH. The desired number of women alternative. Proguanil had been shown in earlier studies to be an effective was recruited within six weeks and they were followed up till delivery. chemoprophylactic drug for malaria during pregnancy when used either singly or in combination with other anti-malarials [16,18,19]. Methods However, there is no study on its effectiveness as an alternative to SP Three hundred and fifty participants were recruited by random in our environment despite its wide use in our practice. This study selection at their booking visit after obtaining an informed consent therefore sought to compare the effectiveness of these two drugs (SP from them. They were then randomized into two groups using a table and Proguanil) when used for malaria chemoprophylaxis in pregnancy. of random numbers. They picked from concealed numbers which Patients and Methods were randomly allocated to contain sulphadoxine-pyrimethamine (Malareich™, Medreich Plc, England) or proguanil (PaludrineTM, Study site and ethical issues AstraZeneca UK Ltd). The numbers were taken to the pharmacy where the drugs were stored and dispensed to them. One group was given This study took place in the Obstetrics and Gynaecology department intermittent preventive treatment for malaria chemoprophylaxis with of the University of Port Harcourt Teaching Hospital in Rivers state two doses of SP while the other group received daily proguanil. Two from January 2010 to September 2010. The University of Port Harcourt doses of SP were given as DOT (Directly Observed Treatment) after Teaching Hospital is a tertiary health institution located in the outskirts quickening, four weeks apart. This was done under the supervision of of Port Harcourt. Port Harcourt is a metropolitan city located in the nurses at the antenatal clinic and recorded in the patients’ antenatal heart of the Niger Delta region of Nigeria. The topography is that of flat case notes. Each dose consisted of three tablets of SP containing 500 mg plains with a network of rivers, tributaries and creeks which have a high of sulphadoxine and 25 mg of pyrimethamine per tablet (Malareich™). potential for breeding of mosquitoes. Malaria transmission is intense The other group received chemoprophylaxis with 100 mg of proguanil year round with a peak during the rainy season months of March to (PaludrineTM) daily. The first dose was also given as DOT in order November and a nadir during the dry season months of December to to avoid bias. Those who were taking daily proguanil were told to February. always take the drug alongside their daily haematinics and bring the The University of Port Harcourt Teaching Hospital Institutional packs to the clinic in their next visit.
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