Effectiveness of pregnant women’s active participation in their antenatal care for the control of malaria and anaemia in pregnancy in Ghana: A cluster randomized controlled trial ISRTCTN88917252 ISRTCTN

Malaria Journal, Volume 17, No. 1, Year 2018

Interpretation

Background: The burden of malaria and anaemia in pregnancy remains high despite the availability of proven efficacious antenatal care interventions. Sub-optimal uptake of the interventions may be due to inadequate active participation of pregnant women in their antenatal care. It was hypothesized that providing opportunities for pregnant women to improve upon active participation in their antenatal care through malaria and anaemia point-of-care testing would improve adherence to ANC recommendations and interventions and lead to better pregnancy outcomes. Methods: Fourteen antenatal clinics in the Ashanti region of Ghana were randomized into intervention (pregnant women participating in their care plus current routine care) and control (current routine care) arms. Pregnant women attending the clinics for the first time were recruited and followed up until delivery. Haemoglobin levels and malaria parasitaemia were measured at baseline, 4-8 weeks after recruitment and at 36-40 weeks gestation. Birth weight and pregnancy outcomes were also recorded. Results: The overall mean age, gestational age and haemoglobin at baseline were 26.4 years, 17.3 weeks and 110 g/l, respectively, with no significant differences between groups; 10.7% had asymptomatic parasitaemia; 74.6% owned an ITN but only 48.8% slept under it the night before enrolment. The adjusted risk ratio by 8 weeks follow up and at 36-40 weeks gestation in the intervention versus the control was 0.97 (95% CI 0.78-1.22) and 0.92 (95% CI 0.63-1.34) for anaemia and 1.17 (95% CI 0.68-2.04) and 0.83 (95% CI 0.27-2.57) for parasitaemia. The adjusted risk ratio for low birth weight was 0.93 (95% CI 0.44-1.97) and for pregnancy complications (abortions, intrauterine fetal deaths and still births) was 0.77 (95% CI 0.17-3.52) in the intervention group versus controls. Conclusion: Although its potential was evident, this study found no significant beneficial effect of women participating in their malaria and haemoglobin tests on pregnancy outcomes. Exploring factors influencing health worker compliance to health intervention implementation and patient adherence to health interventions within this context will contribute in future to improving intervention effectiveness. Trial registration ISRTCTN88917252 The trial was conducted in the Ejisu-Juaben municipality and the Sekyere-East district of the Ashanti region of Ghana (Fig. 2) from September 2012 to April 2014. These two areas lie adjacent to each other in Ghana’s forest region. The Sekyere-East district is predominantly rural while the Ejisu-Juaben municipality has more semi-urban areas. There are a total of four government hospitals in both areas, which serve as referral points for smaller health centres, clinics and maternity homes offering antenatal care. In 2011, antenatal care coverage in the Ejisu-Juaben municipality was 96.1% with an average of 3.7 visits per woman [19] while that of the Sekyere-East district was 70.6% with an average of 4.3 visits per woman [20]. The prevalence of low birth weight (birth weight of less than 2500 g) was 14.2 and 11.9% in the Ejisu-Juaben municipality and Sekyere-East district respectively. Malaria was reported as the topmost reason for outpatient attendance in both areas [19, 20]. The Sekyere-East district and Ejisu-Juaben Municipality, Ashanti region, Ghana All pregnant women of all parities who were visiting the ANC clinics in the two areas for the first time for their current pregnancy were invited to be part of the study according to the eligibility criteria found in Box 1. This was a cluster randomized controlled trial with the ANC clinic being the unit of randomization. Eighteen eligible ANC clinics in the two districts were mapped—using the Global Positioning System to determine their spatial locations and distances between them. An ANC clinic was eligible if registered 10 or more new pregnant women in a month, offered current routine antenatal care services and maternity services. A priori, it was decided that chosen clinics needed to be at least 1.5 km apart so as to reduce the risk of pregnant women crossing over from one ANC clinic to the other during the trial. Based on this, fourteen out of the 18 ANC clinics were finally selected and randomized into intervention and control clinics (Fig. 3) and stratified by the number of registrants (newly booked ANC attendants) per month (large being 20 or more and small being less than 20). A statistician who was independent of the trial performed the randomization using Stata 11 software (StataCorp, College Station, Texas). Each clinic was assigned a unique two-digit code number, which was used to help identify the pregnant women as well and indicated whether they were in the intervention or the control arm of the study. The randomization of the ANC clinics into either the intervention or control arm was not disclosed to the clinic heads and staff during the period of the trial. Table 1 summarizes the features of ANC clinics that were included in the trial. Spatial distribution of antenatal clinics for cluster randomized controlled trial Features of ANC clinics included in trial by arm A total of 93 women per ANC clinic was deemed sufficient to detect a 30% decrease in the prevalence of anaemia from 45% [3, 21], with a power of 80 at 95% confidence interval and assuming a co-efficient of variation of 0.15 and an estimated 20% loss to follow up using the formula by Hayes and Bennet [22]. The choice to use anaemia prevalence over parasitaemia prevalence for sample size estimation was informed by Table 2 summarizes routine recommended ANC services offered in ANC clinics in the study area. These services were carried out in the control and intervention ANC clinics. In addition in the intervention clinics, pregnant women were encouraged to actively participate in anaemia and malaria control aspects of antenatal care using the rapid diagnostic test (RDT), Haemoglobin Colour Scale (HCS) and a pictorial guide (Additional file 1) for malaria and anaemia in pregnancy in the intervention arm. The pictorial guide consists of a series of sketched pictures that depict the causes, signs and symptoms, effects and prevention of malaria and anaemia in pregnancy. It was developed purposely for this study with the help of antenatal care staff in an adjacent district to the study areas to help provide basic and simple health education on malaria and anaemia in pregnancy to the women. The First Response Malaria HRP-2 RDT and the WHO HCS were used in this trial. Recommended components of routine antenatal care [34] The intervention was implemented as described below: ANC staff members in the intervention clinics were trained in a 1-day workshop to use the RDT, HCS and pictorial guide to facilitate pregnant women’s active participation in their antenatal care. All pregnant women that attended ANC in the intervention clinics had the intervention administered even if they were not eligible according to the eligibility criteria (Box 1) to be enrolled in the trial. Active participation in their ANC occurred at each visit of the pregnant women until delivery. The following trial procedures were undertaken for women in both arms. Enrolment of pregnant women occurred simultaneously in all 14 ANC clinics between September 2012 and December 2013 while follow up was till the end of April 2014. Additional information on the implementation fidelity of the intervention was collected to help with the interpretation of the trial results. Non-participatory observations of ANC sessions and exit interviews with pregnant women were conducted in the 9th month of the trial. A trained independent observer used a 10-item checklist (Additional file 3) to observe whether the RDT, HCS and pictorial guide were being used accordingly for the active participation of the pregnant women. Short exit interviews were also conducted with up to 5 pregnant women per ANC clinic on the same day of observations to ascertain the processes they had been through during their ANC according to a 12-item checklist (Additional file 4). The women were shown the RDT, HCS and pictorial guide and asked to confirm or not whether they were used during their ANC for their active participation. Data were collected using a pre-designed case report form for each pregnant woman. All data were double entered using Microsoft Access 2007 computer software and discrepancies corrected by manual crosschecking with the case report forms. After data were cleaned, they were analysed using Stata version 13 (StataCorp, College Station, Texas). Descriptive statistics was used to describe the pregnant women at the individual and ANC clinic levels and any imbalances in covariates and potential confounders identified. The intervention effect was analysed by a modified per protocol analysis. This meant using data available for all women who had successfully been followed up at each pre-specified time point regardless of whether the woman had all measurements recorded for all the time points or not. Assessment of the intervention effect was done at the ANC clinic level as follows: (1) Estimating risks of the endpoints (malaria parasitaemia and anaemia prevalence, low birth weight and sub-optimal pregnancy outcomes-abortions, intrauterine deaths and still births) for each antenatal clinic. (2) Finding the mean risk per arm. (3) Comparing the means using the student T test per arm as risk ratios. All analyses were adjusted for baseline parasitaemia and anaemia, gestation at enrolment, maternal age, educational level, ITN use, parity and IPTp received. Data for knowledge of pregnant women about malaria and anaemia in pregnancy, adherence to iron and folate supplementation and intervention implementation fidelity were also analysed according to Additional files 5, 6 and 7 and are reported in Tables 7 and and8,8, respectively. Comparison of mean proportions of women’s knowledge on malaria, anaemia and adherence by arm Implementation fidelity-Intervention implementation activities against expected activities (percentage of agreement-POA) of intervention clinics

AI Digest

Study Justification:

The burden of malaria and anaemia in pregnancy remains high in Ghana, despite the availability of effective antenatal care interventions. This study aimed to investigate whether active participation of pregnant women in their antenatal care, specifically through point-of-care testing for malaria and anaemia, would improve adherence to ANC recommendations and interventions and lead to better pregnancy outcomes.

Highlights:

– The study was conducted in the Ashanti region of Ghana, specifically in the Ejisu-Juaben municipality and the Sekyere-East district.
– Fourteen antenatal clinics were randomized into intervention and control arms.
– Pregnant women attending the clinics for the first time were recruited and followed up until delivery.
– Haemoglobin levels and malaria parasitaemia were measured at baseline, 4-8 weeks after recruitment, and at 36-40 weeks gestation.
– Birth weight and pregnancy outcomes were recorded.
– The study found no significant beneficial effect of women participating in their malaria and haemoglobin tests on pregnancy outcomes.
– The results suggest the need to explore factors influencing health worker compliance and patient adherence to improve intervention effectiveness.

Recommendations:

Based on the study findings, the following recommendations can be made:

1. Further research should be conducted to identify barriers to health worker compliance and patient adherence in antenatal care interventions.
2. Strategies should be developed to improve active participation of pregnant women in their antenatal care, with a focus on addressing these barriers.
3. Health education programs should be implemented to increase knowledge and awareness of malaria and anaemia in pregnancy among pregnant women.

Key Role Players:

1. Researchers and scientists: To conduct further research and develop strategies for improving intervention effectiveness.
2. Health workers: To implement the recommended strategies and provide adequate antenatal care services.
3. Policy makers: To support and allocate resources for research, implementation, and monitoring of interventions.
4. Community leaders and organizations: To collaborate in health education programs and promote active participation of pregnant women in their antenatal care.

Cost Items for Planning Recommendations:

1. Research funding: To support further research and studies on health worker compliance and patient adherence.
2. Training and capacity building: To train health workers on implementing strategies for improving intervention effectiveness.
3. Health education materials: To develop and distribute educational materials on malaria and anaemia in pregnancy.
4. Monitoring and evaluation: To assess the implementation and impact of the recommended strategies.
5. Community engagement: To involve community leaders and organizations in health education programs and interventions.

Strength of Evidence

The strength of evidence for this abstract is 6 out of 10.
The evidence in the abstract is moderately strong, but there are some limitations that could be addressed to improve it. The study design is a cluster randomized controlled trial, which is generally considered a strong design. However, the sample size is relatively small, with only 14 antenatal clinics included in the study. Additionally, the results show no significant beneficial effect of women participating in their malaria and haemoglobin tests on pregnancy outcomes. To improve the strength of the evidence, future studies could consider increasing the sample size to improve statistical power and include a larger number of clinics. Additionally, exploring factors influencing health worker compliance and patient adherence to health interventions could provide valuable insights into improving intervention effectiveness.

Abstract

The trial was conducted in the Ejisu-Juaben municipality and the Sekyere-East district of the Ashanti region of Ghana (Fig. 2) from September 2012 to April 2014. These two areas lie adjacent to each other in Ghana’s forest region. The Sekyere-East district is predominantly rural while the Ejisu-Juaben municipality has more semi-urban areas. There are a total of four government hospitals in both areas, which serve as referral points for smaller health centres, clinics and maternity homes offering antenatal care. In 2011, antenatal care coverage in the Ejisu-Juaben municipality was 96.1% with an average of 3.7 visits per woman [19] while that of the Sekyere-East district was 70.6% with an average of 4.3 visits per woman [20]. The prevalence of low birth weight (birth weight of less than 2500 g) was 14.2 and 11.9% in the Ejisu-Juaben municipality and Sekyere-East district respectively. Malaria was reported as the topmost reason for outpatient attendance in both areas [19, 20]. The Sekyere-East district and Ejisu-Juaben Municipality, Ashanti region, Ghana All pregnant women of all parities who were visiting the ANC clinics in the two areas for the first time for their current pregnancy were invited to be part of the study according to the eligibility criteria found in Box 1. This was a cluster randomized controlled trial with the ANC clinic being the unit of randomization. Eighteen eligible ANC clinics in the two districts were mapped—using the Global Positioning System to determine their spatial locations and distances between them. An ANC clinic was eligible if registered 10 or more new pregnant women in a month, offered current routine antenatal care services and maternity services. A priori, it was decided that chosen clinics needed to be at least 1.5 km apart so as to reduce the risk of pregnant women crossing over from one ANC clinic to the other during the trial. Based on this, fourteen out of the 18 ANC clinics were finally selected and randomized into intervention and control clinics (Fig. 3) and stratified by the number of registrants (newly booked ANC attendants) per month (large being 20 or more and small being less than 20). A statistician who was independent of the trial performed the randomization using Stata 11 software (StataCorp, College Station, Texas). Each clinic was assigned a unique two-digit code number, which was used to help identify the pregnant women as well and indicated whether they were in the intervention or the control arm of the study. The randomization of the ANC clinics into either the intervention or control arm was not disclosed to the clinic heads and staff during the period of the trial. Table 1 summarizes the features of ANC clinics that were included in the trial. Spatial distribution of antenatal clinics for cluster randomized controlled trial Features of ANC clinics included in trial by arm A total of 93 women per ANC clinic was deemed sufficient to detect a 30% decrease in the prevalence of anaemia from 45% [3, 21], with a power of 80 at 95% confidence interval and assuming a co-efficient of variation of 0.15 and an estimated 20% loss to follow up using the formula by Hayes and Bennet [22]. The choice to use anaemia prevalence over parasitaemia prevalence for sample size estimation was informed by Table 2 summarizes routine recommended ANC services offered in ANC clinics in the study area. These services were carried out in the control and intervention ANC clinics. In addition in the intervention clinics, pregnant women were encouraged to actively participate in anaemia and malaria control aspects of antenatal care using the rapid diagnostic test (RDT), Haemoglobin Colour Scale (HCS) and a pictorial guide (Additional file 1) for malaria and anaemia in pregnancy in the intervention arm. The pictorial guide consists of a series of sketched pictures that depict the causes, signs and symptoms, effects and prevention of malaria and anaemia in pregnancy. It was developed purposely for this study with the help of antenatal care staff in an adjacent district to the study areas to help provide basic and simple health education on malaria and anaemia in pregnancy to the women. The First Response Malaria HRP-2 RDT and the WHO HCS were used in this trial. Recommended components of routine antenatal care [34] The intervention was implemented as described below: ANC staff members in the intervention clinics were trained in a 1-day workshop to use the RDT, HCS and pictorial guide to facilitate pregnant women’s active participation in their antenatal care. All pregnant women that attended ANC in the intervention clinics had the intervention administered even if they were not eligible according to the eligibility criteria (Box 1) to be enrolled in the trial. Active participation in their ANC occurred at each visit of the pregnant women until delivery. The following trial procedures were undertaken for women in both arms. Enrolment of pregnant women occurred simultaneously in all 14 ANC clinics between September 2012 and December 2013 while follow up was till the end of April 2014. Additional information on the implementation fidelity of the intervention was collected to help with the interpretation of the trial results. Non-participatory observations of ANC sessions and exit interviews with pregnant women were conducted in the 9th month of the trial. A trained independent observer used a 10-item checklist (Additional file 3) to observe whether the RDT, HCS and pictorial guide were being used accordingly for the active participation of the pregnant women. Short exit interviews were also conducted with up to 5 pregnant women per ANC clinic on the same day of observations to ascertain the processes they had been through during their ANC according to a 12-item checklist (Additional file 4). The women were shown the RDT, HCS and pictorial guide and asked to confirm or not whether they were used during their ANC for their active participation. Data were collected using a pre-designed case report form for each pregnant woman. All data were double entered using Microsoft Access 2007 computer software and discrepancies corrected by manual crosschecking with the case report forms. After data were cleaned, they were analysed using Stata version 13 (StataCorp, College Station, Texas). Descriptive statistics was used to describe the pregnant women at the individual and ANC clinic levels and any imbalances in covariates and potential confounders identified. The intervention effect was analysed by a modified per protocol analysis. This meant using data available for all women who had successfully been followed up at each pre-specified time point regardless of whether the woman had all measurements recorded for all the time points or not. Assessment of the intervention effect was done at the ANC clinic level as follows: (1) Estimating risks of the endpoints (malaria parasitaemia and anaemia prevalence, low birth weight and sub-optimal pregnancy outcomes-abortions, intrauterine deaths and still births) for each antenatal clinic. (2) Finding the mean risk per arm. (3) Comparing the means using the student T test per arm as risk ratios. All analyses were adjusted for baseline parasitaemia and anaemia, gestation at enrolment, maternal age, educational level, ITN use, parity and IPTp received. Data for knowledge of pregnant women about malaria and anaemia in pregnancy, adherence to iron and folate supplementation and intervention implementation fidelity were also analysed according to Additional files 5, 6 and 7 and are reported in Tables 7 and and8,8, respectively. Comparison of mean proportions of women’s knowledge on malaria, anaemia and adherence by arm Implementation fidelity-Intervention implementation activities against expected activities (percentage of agreement-POA) of intervention clinics

Materials

Innovations

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

1. Mobile health (mHealth) applications: Develop mobile applications that provide pregnant women with information and reminders about antenatal care, malaria and anaemia prevention, and other important aspects of maternal health. These apps could also include features for tracking appointments, test results, and medication adherence.

2. Community health workers: Train and deploy community health workers to provide education and support to pregnant women in their communities. These workers can help increase awareness about the importance of antenatal care, malaria and anaemia prevention, and provide guidance on accessing healthcare services.

3. Telemedicine: Implement telemedicine services to enable pregnant women in remote areas to consult with healthcare providers and receive guidance on antenatal care, malaria and anaemia prevention, and other maternal health concerns. This can help overcome geographical barriers and improve access to healthcare services.

4. Point-of-care testing: Expand the use of point-of-care testing for malaria and anaemia in antenatal clinics. This can provide immediate results and enable healthcare providers to make timely interventions and recommendations for pregnant women.

5. Health education campaigns: Conduct targeted health education campaigns to raise awareness about the importance of antenatal care, malaria and anaemia prevention, and other maternal health topics. These campaigns can utilize various channels such as radio, television, community meetings, and social media to reach a wide audience.

6. Integration of services: Improve coordination and integration of maternal health services with other healthcare services, such as family planning and HIV/AIDS prevention and treatment. This can ensure that pregnant women receive comprehensive care and address multiple health needs simultaneously.

7. Quality improvement initiatives: Implement quality improvement initiatives in antenatal clinics to enhance the overall quality of care provided to pregnant women. This can involve training healthcare providers, improving infrastructure and equipment, and implementing standardized protocols and guidelines.

These innovations have the potential to improve access to maternal health by increasing awareness, providing convenient access to information and services, and improving the quality of care provided. However, further research and evaluation are needed to assess their effectiveness and feasibility in the specific context of Ghana.

AI Innovations Description

The recommendation from the study is to provide pregnant women with opportunities to actively participate in their antenatal care through malaria and anaemia point-of-care testing. This can be done by training ANC staff members to use rapid diagnostic tests (RDTs), haemoglobin colour scales (HCS), and a pictorial guide to facilitate pregnant women’s active participation in their antenatal care. The pictorial guide consists of sketched pictures that provide basic and simple health education on malaria and anaemia in pregnancy. Pregnant women attending ANC clinics would have the intervention administered, even if they are not eligible to be enrolled in the trial. The effectiveness of this approach was evaluated through a cluster randomized controlled trial in Ghana. However, the study found no significant beneficial effect of women participating in their malaria and haemoglobin tests on pregnancy outcomes. Further research is needed to explore factors influencing health worker compliance and patient adherence to improve intervention effectiveness.

AI Innovations Methodology

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

1. Strengthen health worker compliance: Explore factors influencing health worker compliance to health intervention implementation. This could involve training and education programs to ensure that health workers are knowledgeable and motivated to provide high-quality antenatal care services.

2. Enhance patient adherence: Investigate factors influencing patient adherence to health interventions. This could involve providing education and counseling to pregnant women to increase their understanding of the importance of antenatal care and encourage them to actively participate in their own care.

3. Improve access to point-of-care testing: Increase the availability and accessibility of point-of-care testing for malaria and anaemia during antenatal care visits. This could involve providing the necessary equipment and training to health facilities, as well as ensuring that pregnant women are aware of and have access to these testing services.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could be developed as follows:

1. Define the outcome measures: Determine the specific indicators that will be used to measure the impact of the recommendations, such as the percentage of pregnant women attending antenatal care visits, the percentage of pregnant women receiving point-of-care testing, and the prevalence of malaria and anaemia among pregnant women.

2. Collect baseline data: Gather data on the current state of access to maternal health services, including the number of pregnant women attending antenatal care visits, the availability of point-of-care testing, and the prevalence of malaria and anaemia.

3. Implement the recommendations: Introduce the recommended interventions, such as strengthening health worker compliance and enhancing patient adherence, as well as improving access to point-of-care testing. Monitor the implementation process and collect data on the uptake of these interventions.

4. Analyze the data: Compare the data collected after implementing the recommendations to the baseline data. Calculate the changes in the outcome measures and assess the impact of the recommendations on improving access to maternal health.

5. Interpret the results: Analyze the findings to determine the effectiveness of the recommendations in improving access to maternal health. Identify any challenges or barriers that may have influenced the outcomes and make recommendations for further improvements.

6. Continuously monitor and evaluate: Establish a system for ongoing monitoring and evaluation to ensure that the recommendations are sustained and continue to have a positive impact on access to maternal health. Regularly collect data and assess the progress made, making adjustments as necessary.

By following this methodology, it will be possible to simulate the impact of the recommendations on improving access to maternal health and identify strategies for further improvement.

Author

Dima Health

Statistics:

Citations: 10

Identifiers:

DOI: 10.1186/s12936-018-2387-1

Research Areas:

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

Study Countries:

Ghana

Study Design:

Cross Sectional Study, randomised-control-trial

Study Approach:

Quantitative

Participants Gender:

Female