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Background: Malaria in pregnancy is a major health problem that can cause maternal anaemia, stillbirth, spontaneous abortion, low birth weight and intra-uterine stunting. The WHO recommends use of sulphadoxine-pyrimethamine (SP) for intermittent preventive treatment of malaria during pregnancy (IPTp) in endemic areas. Towards monitoring and assessing IPTp coverage in the population, the Roll Back Malaria Partnership recommends the use of self-reported data. The aim of this study was to assess the validity of self-reported IPTp by testing for sulphadoxine in maternal blood at delivery. Methods: Two hundred and four pregnant women were consented and enrolled in a cross-sectional study in Mulago National Referral Hospital in Kampala Uganda. – Participants who reported a history of taking sulpha-containing drugs like co-trimoxazole , those who were not sure of dates relating to last menstrual period or who took IPTp within the first 20 weeks of gestation were excluded from the study. Data on demographic characteristics, obstetric history, and delivery outcome were collected. At birth, maternal venous blood was taken off aseptically and used to make thick blood smears for malaria parasites and plasma for determining sulphadoxine using high performance liquid chromatography (HPLC). Results: Of 120 participants who self reported to have used IPTp, 35 (29.2%) tested positive for sulphadoxine by HPLC, while 63 (75%) of 84 patients who reported not having used IPTp tested negative for sulphadoxine. Participants possessing post-primary education were more likely to have reported using IPTp. The low agreement (kappa coefficient = 0.037) between self-report and actual presence of the drug in the blood casts doubt on the validity of self-reported data in estimating IPTp coverage. Conclusions: The results of this study question the accuracy of self-reported data in estimating IPTp coverage in the population. More studies on validity of self reported data are recommended. Since the validity of IPTp self reports is vital for guiding policy on malaria control in pregnancy, ways should be sought to improve accuracy of the information from such reports. © 2012 Namusoke et al.; licensee BioMed Central Ltd.
The study was carried out in Mulago Hospital, which serves as Uganda’s National Referral Hospital and is located in the capital city of Kampala. Situated at 1,300–1,500 m above sea level close to the Equator, Kampala has a tropical climate with rainfalls throughout the year. There is stable P. falciparum transmission in 95% of Uganda. The remaining 5% of the country, mainly the highland areas with altitudes >1,600 m, experiences low and unstable malaria transmission. Kampala has low to intermediate malaria transmission with frequency peaks toward the end of the two major rain seasons (March to May and August to November). The national treatment guidelines recommend that pregnant women should receive at least two doses of SP to prevent malaria and its effects. At time of this study, HIV prevalence in the Ugandan population aged 15 to 49 years was 6.4% and prevalence among admitted patients at Mulago Hospital was 10%. Pregnant mothers with known HIV infection are expected to follow national guidelines of weekly trimethoprim-sulphamethoxazole (co-trimoxazole) prophylaxis to prevent opportunistic infections. Two hundred and four pregnant women admitted at Mulago National Referral Hospital labour suite were enrolled into a cross–sectional study after informed oral and written consent. Data on pregnancy history, socio-economic indicators and pregnancy outcomes was collected using a pre-coded standardized questionnaire. Key aspects recorded included area of residence, age, marital status, occupation, education, parity, visits to antenatal clinic (ANC) and bed net use. Birth weight of baby was determined after delivery. In addition, information on use of IPT for prevention of malaria during that pregnancy, the drug administered, number of SP doses taken, history of taking sulpha-containing drugs such as co-trimoxazole , history of fever during pregnancy, and use of anti-malarial drugs was recorded. The date on which the SP was taken was noted in the questionnaire. In cases where the patient was not able to state the dates with certainty, it was then recorded as the 15th day of that particular month. This information was used to estimate the gestation age corresponding to when the SP was taken. All ethical aspects of the study were approved by the Makerere University Faculty of Medicine Research and Ethics Committee and the Uganda National Council of Science and Technology (UNCST). Before delivery of baby, mother’s venous blood was collected for microscopy to detect parasites, for haemoglobin estimation and sulphadoxine (SDX) detection. Blood was collected in EDTA anticoagulant containing tubes, centrifuged, plasma separated and stored at −70°C until drug assays. Thick blood smears were made from the maternal venous blood and the cord blood. These were then stained with Giemsa and examined microscopically by two trained workers. In case of discrepancy, a third microscopist examined the smears. Plasma drug levels were assayed using the high performance liquid chromatography (HPLC) facility at the Department of Pharmacology and Therapeutics, College of Health Sciences, Makerere University, Kampala, Uganda. Sulphadoxine was used as a proxy for SP. The HPLC analysis (UV) was carried out according to the method described by Bergqvist et al.[14]. Sulphamethaxazole was used as the internal standard. The limit of quantification for SDX was 15 μM. Basing on average Cmax for SDX of 260 μM and assuming a half life (T1/2) for SDX of 6 to 9 days [15,16], it is calculated that SDX is detectable in blood from few hours after intake of SP until 7 to 9 weeks. Therefore, participants who reported as having taken IPTp before 20 weeks of their pregnancy were excluded from HPLC analysis. In addition, HIV-positive participants who reported being on co-trimoxazole prophylaxis were excluded since this antifolate combination is similar to SP and is a sulpha-containing drug that can interfere with HPLC detection of SDX. Further, as it was important to know the time interval between IPTp intake and blood sampling at delivery, the blood specimens of individuals who were unsure of the month of their last menstrual period (period of amenorrhea) were excluded. All plasma specimens were analysed twice along with calibration standards and quality controls. To prevent bias, the HPLC analysts were blinded to the data of self-reported IPTp uptake and composition of quality control samples. Data was cleaned, coded and entered into Microsoft Access 2007. Summary statistics, Chi-square tests, multivariate analysis and graphs of residual plasma concentrations of SDX were carried out using SPSS. Agreement or disagreement between self-report and HPLC results on actual detection of SDX in blood at delivery was determined by calculating kappa coefficients [17]. A kappa value of 0.1 to 0.40 was considered poor-to-fair agreement, a kappa value of 0.41 to 0.60 was considered moderate agreement, and a kappa value of 0.61 to 0.80 was considered substantial agreement, while a kappa value of 0.81 to 1.00 was considered excellent agreement.
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