Intermittent preventive treatment for malaria in pregnancy: Is directly observed therapy still necessary? A prospective cohort study in a tertiary hospital, Southern Nigeria

INTRODUCTION

Malaria has been recognized as a public health priority since the beginning of 1980s.^[1] Most cases and deaths due to the disease occur in African region.^[2] In Africa, about 30 million women living in malaria endemic areas become pregnant each year.^[3] From the 2015 WHO Global Malaria report,^[4] about 3.2 billion people were at risk of malaria. In 2015 alone 430,000 people died due to complications of malaria.^[4] Most of these deaths occurred in pregnant women and children in sub-Saharan Africa. Specifically, 35% of these deaths occurred in two countries, namely, Nigeria and Democratic Republic of Congo.^[4] For women of reproductive age group in this region, malaria is a serious threat to their survival and their infants’ health.

Pregnant women are particularly vulnerable to malaria as pregnancy reduces a woman’s immunity to malaria infection and increases the risk of illness, severe anemia, and death.^[5] The severity of clinical manifestations is determined by the level of immunity before pregnancy, which depends on the intensity and stability of malaria transmission.^[1] In low and/or unstable transmission areas, the degree of acquired immunity of women before pregnancy is low, and both the mother and her fetus are at risk for the most severe consequences of infection.^[5,6] In contrast, in areas of high malaria transmission, women have acquired a protective immunity before pregnancy.^[5-7]

In areas of stable transmission, where adult women have considerable acquired immunity Plasmodium falciparum infection during pregnancy typically does not cause symptomatic malaria but may lead to maternal anemia and placental malaria due to sequestration of the parasite in the placenta,^[4] especially among women having their first and second children.^[4,5] This placenta malaria leads to the low- birth weight, the single greatest risk factor for neonatal death and a major contributor to infant death.^[1-3]

Following a randomized trial in Tanzania in 1999 which proved that intermittent preventive treatment (IPT) of pregnant women and children with sulfadoxine/ pyrimethamine (S/P) effectively reduced the incidence of clinical malaria, the WHO included IPT as a major strategy to combat malaria in pregnancy.^[8] When IPT was first adopted by the WHO, the recommendation was that it should be dispensed using the directly observed therapy (DOT) to ensure effectiveness of treatment.^[9] The Federal Ministry of Health in Nigeria and most other African countries then formulated a policy whereby IPT was include in antenatal care (ANC) package to ensure distribution of the drug to pregnant women during ANC in public health facilities,^[3,10]

The Africa Summit on Roll Back Malaria in April 2000 adopted the Abuja declaration in which regional leaders committed to ensuring that 60% of pregnant women in malaria-endemic communities accessed effective prevention and treatment of malaria by 2005.^[3]

However, almost two decades after the initial adoption of this treatment protocols, the coverage for IPT is still reported very low. Apart from unevenly distribution of public health facilities women who receive ANC in private health or faith based clinics are not gathered for. A recent study has shown that IPT by DOT is no more sustainable in many setting in view of the dwindling government resources. Sometimes the administration of the drug by a health worker, if available is met with other challenges related to women coming to clinic without food and nonavailability of clean drinking water in the facilities.^[11]

These raise the fundamental questions: What is the level of awareness among the women? What is the rate of compliance or drug adherent among women who receive prescription from their service providers to purchase the drug out of their pockets for self-administration? And very importantly, is DOT still necessary for administration of IPT to pregnant women? Hence, the objective of this study was to determine whether DOT significantly reduces incidences of malaria in pregnancy and neonatal malaria.

MATERIAL AND METHODS

RESULTS

DISCUSSION

This study aimed to assess the impact of DOT regarding malaria control in the delivery of IPT to pregnant women in a public health facility in southern Nigeria. One disease which treatment and control have largely been believed to be successful through DOT is tuberculosis. This is because of the longer duration of therapy needed for cure. In this case, apart from the health workers monitoring to ensure drug adherence, the side effect of the drugs is also often detected and modification in the treatment plan instituted during this period.^[14] This may not necessary apply to IPT which involves single drug dose, taken twice or more, in all setting especially where women and families are empowered. Furthermore, although previous case series suggested that DOT increased treatment completion and decrease drug resistance for tuberculosis in communities, a meta-analysis of randomized clinical trials of DOT has shown no significant impact of DOT on treatment outcomes.^[15,16]

This study failed to show any significant difference in the interval blood malaria parasite count and placental parasitemia between the IPT-DOT and the non-IPT-DOT treated (control) women (P = 0.215). The positive parasite test was used to indirectly assess drug adherence and treatment effectiveness which is the main reason for adopting DOT method for IPT as self-reporting adherence may not be as reliable in assessing drug compliance.^[17] This is in contrast to findings in a study in Tanzania which reported that free drug availability significantly improved uptake of IPT (0.0001).^[17] This was a multi-centered study in different rural communities unlike our study which took place in a tertiary hospital in an urban area. Most of those rural women might not have educated on preventive medicine and also perhaps not financially empowered. Other studies also revealed that rural women were less likely to take two or more doses of IPT compared to their urban counterparts.^[18,19]

One of the main risks in malaria infection in pregnancy is maternal anemia due to hemolysis. Infant low birth weight and intrauterine growth restriction are also due to maternal chronic anemia. The post-treatment hemoglobin values were determined during the time of checking for interval malaria parasite count. There was no significant difference in incidence of anemia in the two groups (0.966). However, the social profile of the women negatively correlated with incidence of anemia in pregnancy across both groups. This is in keeping with the previous studies which show that the social profile of women such as level of education, age, and marital status is major determinants of anemia in pregnancy.^[20,21]

Among the major factors affecting medication adherence are the level of education and the level of family income. Hence, the method used in calculating the social class of the women in this study incorporated highest level of educational qualification of the women and the occupation of their spouses since majority of them were married.^[22] The study did not show that social factor affects uptake of IPT. One of the advantages of adopting S/P as a drug of choice for IPT is that of low cost of the drug. This makes it available in many dispensary outlets in communities and easily accessible and affordable by the low-income earners. Moreover, the medication is administered once a month unlike hematinic which requires daily administration throughout the period of pregnancy.

CONCLUSION

Administration of sulfadoxine-pyrimethamine for IPT of pregnant women is still an effective strategy for control of malaria in endemic areas. However, its delivery through DOT may not necessarily improve uptake especially in urban areas. Education, ante natal counseling, and improved status of women and families may promote healthy pregnancy.