Validity of self-reported use of sulphadoxine-pyrimethamine intermittent presumptive treatment during pregnancy (IPTp): A cross-sectional study

Malaria Journal, Volume 11, Year 2012

Interpretação

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.

AI Digest

Study Justification:

– Malaria in pregnancy is a significant health problem that can have serious consequences for both the mother and the baby.
– The World Health Organization (WHO) recommends the use of sulphadoxine-pyrimethamine (SP) for intermittent preventive treatment of malaria during pregnancy (IPTp) in endemic areas.
– To monitor and assess IPTp coverage in the population, self-reported data is commonly used.
– This study aimed to assess the validity of self-reported IPTp by testing for sulphadoxine in maternal blood at delivery.

Study Highlights:

– The study was conducted in Mulago National Referral Hospital in Kampala, Uganda, which serves as the country’s main referral hospital.
– A total of 204 pregnant women were enrolled in the study.
– Data on demographic characteristics, obstetric history, and delivery outcome were collected.
– Maternal venous blood was collected at delivery and tested for sulphadoxine using high performance liquid chromatography (HPLC).
– The results showed low agreement between self-reported IPTp use and actual presence of the drug in the blood, casting doubt on the validity of self-reported data in estimating IPTp coverage.

Study Recommendations:

– More studies on the validity of self-reported data are recommended to further assess the accuracy of IPTp coverage estimates.
– Ways should be sought to improve the accuracy of information obtained from self-reported data, as the validity of IPTp self-reports is crucial for guiding policy on malaria control in pregnancy.

Key Role Players:

– Researchers and scientists involved in conducting the studies on the validity of self-reported data.
– Healthcare providers and policymakers responsible for implementing and monitoring malaria control programs.
– Community health workers and volunteers who can help collect accurate data on IPTp use from pregnant women.

Cost Items for Planning Recommendations:

– Research funding for conducting additional studies on the validity of self-reported data.
– Training and capacity building for healthcare providers and community health workers to improve data collection accuracy.
– Resources for implementing interventions to improve accuracy of self-reported data, such as educational campaigns and awareness programs.
– Monitoring and evaluation costs to assess the impact of interventions on the accuracy of self-reported data.

Força da prova

The strength of evidence for this abstract is 6 out of 10.
The evidence in the abstract is moderately strong (6) because the study design is cross-sectional and includes a sample size of 204 pregnant women. The study collected data on demographic characteristics, obstetric history, and delivery outcomes, and used high performance liquid chromatography (HPLC) to test for sulphadoxine in maternal blood at delivery. However, the study does not provide information on the representativeness of the sample or the generalizability of the findings. To improve the strength of the evidence, future studies could consider using a larger and more diverse sample, and include information on the representativeness of the sample and the generalizability of the findings.

Resumo

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.

Materiais

N/A

Inovações

Based on the information provided, here are some potential innovations that could improve access to maternal health:

1. Mobile health (mHealth) applications: Develop mobile apps that provide information and reminders about the importance of taking sulphadoxine-pyrimethamine (SP) for intermittent preventive treatment of malaria during pregnancy (IPTp). These apps could also track and monitor IPTp coverage and send notifications to pregnant women when it’s time for their next dose.

2. Point-of-care testing: Develop rapid diagnostic tests that can detect the presence of sulphadoxine in maternal blood at delivery. These tests could be used in healthcare facilities to quickly determine if a pregnant woman has received IPTp and provide appropriate treatment if necessary.

3. Community health workers: Train and equip community health workers to educate pregnant women about the importance of IPTp and provide them with the necessary medication. These workers could also collect data on IPTp coverage and report it to healthcare facilities for monitoring and evaluation.

4. Integration of services: Integrate IPTp services with other maternal health services, such as antenatal care and HIV prevention and treatment. This could improve access to IPTp for pregnant women who are already accessing these services and ensure that they receive comprehensive care.

5. Public awareness campaigns: Launch public awareness campaigns to educate pregnant women and their communities about the benefits of IPTp and encourage them to seek and utilize these services. These campaigns could use various communication channels, such as radio, television, and community meetings, to reach a wide audience.

It’s important to note that these are just potential recommendations based on the information provided. Further research and evaluation would be needed to determine the feasibility and effectiveness of these innovations in improving access to maternal health.

AI Innovations Description

The study mentioned in the description aimed to assess the validity of self-reported use of sulphadoxine-pyrimethamine (SP) for intermittent preventive treatment of malaria during pregnancy (IPTp) in Uganda. The researchers collected data from 204 pregnant women at Mulago National Referral Hospital in Kampala. They tested for the presence of sulphadoxine in maternal blood at delivery using high performance liquid chromatography (HPLC).

The results of the study showed that there was a low agreement between self-reported use of IPTp and the actual presence of sulphadoxine in the blood. Of the participants who self-reported using IPTp, only 29.2% tested positive for sulphadoxine. On the other hand, 75% of the participants who reported not using IPTp tested negative for sulphadoxine.

Based on these findings, the study questions the accuracy of self-reported data in estimating IPTp coverage in the population. The researchers recommend conducting more studies on the validity of self-reported data. They also emphasize the importance of improving the accuracy of information obtained from self-reports, as it is crucial for guiding policy on malaria control in pregnancy.

In summary, the recommendation that can be developed into an innovation to improve access to maternal health is to find ways to enhance the accuracy of self-reported data on the use of interventions like IPTp. This could involve implementing strategies such as improved data collection methods, increased training and awareness among healthcare providers and pregnant women, and the use of technology to facilitate data collection and monitoring.

AI Innovations Methodology

Based on the provided information, here are some potential recommendations to improve access to maternal health:

1. Strengthening Antenatal Care (ANC) Services: Enhance the quality and availability of ANC services by ensuring that pregnant women have access to regular check-ups, screenings, and education on maternal health.

2. Increasing Community Awareness: Implement community-based programs to raise awareness about the importance of maternal health and the available services. This can be done through health campaigns, community meetings, and the use of local media.

3. Improving Transportation: Address transportation barriers by providing reliable and affordable transportation options for pregnant women to access healthcare facilities. This can include the use of ambulances, mobile clinics, or transportation vouchers.

4. Enhancing Health Information Systems: Develop and implement robust health information systems to accurately track and monitor maternal health indicators. This can help identify gaps in service delivery and inform targeted interventions.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could include the following steps:

1. Define the indicators: Identify specific indicators that reflect access to maternal health, such as the number of ANC visits, the percentage of pregnant women receiving IPTp, or the distance traveled to reach a healthcare facility.

2. Collect baseline data: Gather data on the current status of the selected indicators. This can be done through surveys, interviews, or existing health records.

3. Introduce the recommendations: Implement the recommended interventions in a selected area or population. This could be done through pilot projects or phased implementation.

4. Monitor and evaluate: Continuously monitor the selected indicators to assess the impact of the interventions. This can involve collecting data at regular intervals and comparing it to the baseline data.

5. Analyze the data: Use statistical analysis techniques to analyze the collected data and determine the impact of the interventions on the selected indicators. This can include calculating percentages, conducting regression analysis, or using other appropriate statistical methods.

6. Draw conclusions and make recommendations: Based on the analysis of the data, draw conclusions about the effectiveness of the interventions in improving access to maternal health. Make recommendations for scaling up successful interventions or modifying strategies as needed.

7. Repeat the process: Continuously repeat the monitoring and evaluation process to assess the long-term impact of the interventions and make further improvements.

By following this methodology, policymakers and healthcare providers can gain insights into the effectiveness of different interventions and make informed decisions to improve access to maternal health.

Autor

Dima Health

Statistics:

Citations: 14

Identifiers:

DOI: 10.1186/1475-2875-11-310

Research Areas:

Community Interventions, Food Security, Health System and Policy, Infectious Diseases, Maternal Access, Maternal and Child Health, Quality of Care, Sexual and Reproductive Health, Social Determinants, Technology and Innovations

Study Countries:

Uganda

Study Design:

Cross Sectional Study

Study Approach:

Quantitative

Participants Gender:

Female

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