Documents from all five countries demonstrated conflicting and/or inconsistent guidance about timing and dose of IPTp-SP, although all countries recommended at least monthly intervals between doses (Table 4). For example, in Kenya the first dose of IPTp-SP was recommended after quickening in the national malaria guidelines, at 16 weeks or after quickening in the supervision guidelines and one in-service training package, and at 16 weeks in another in-service training package. Only the malaria guidelines specified the correct dose of SP for IPTp. In Mali, malaria guidelines recommended two doses of IPTp-SP, the first at 16 weeks and the second at least one month later and before the ninth month of pregnancy, while RH guidelines stated that the first dose should be given at 24–28 weeks, and the second at 32–36 weeks. The training package and supervision guidelines recommended two doses between the fourth and eighth months of pregnancy. Mozambique’s malaria guidelines stipulated two doses of IPTp-SP after 20 weeks while RH guidelines recommended three doses after 20 weeks, quickening or auscultation of foetal heart tones. In mainland Tanzania, malaria guidelines and in-service and pre-service education packages recommended the first dose of IPTp-SP at 20–24 weeks and the second dose at 28–32 weeks, while the quality improvement tool for ANC recommended the first dose at 20 weeks or more but gave no information about subsequent doses. Uganda’s malaria guidelines recommended the first dose between the fourth and sixth months, and the second between the seventh and ninth months of pregnancy, while the RH policy stipulated the first dose be given between 24–28 weeks, and the second at less than 36 weeks.

At the time of this review, two countries (Kenya and Mali) routinely used high-dose folic acid (5 mg daily) during pregnancy in conjunction with iron supplementation. The WHO 2004 recommendations for IPTp-SP did not specify doses for iron or folate during pregnancy, though WHO 1998 guidelines recommended 60 mg iron and .25 mg – 0.4 mg folate daily [16]. Thus the use of higher dose folic acid was inconsistent with the WHO guidelines at that time. In Mali, only the Focused Antenatal Care (FANC) Reference Manual recommended suspending folic acid for one week after IPTp-SP. Kenya previously recommended suspending 5 mg folic acid for two weeks after IPTp-SP administration; however, the policy has since changed to provide folic acid 0.4 mg daily during pregnancy, and folic acid is no longer suspended.

All countries except Mali had national malaria and RH policies and guidelines specifying that IPTp-SP should be given by DOT. In all four of these countries, national pre-service and in-service training documents also directed that IPTp-SP should be provided by DOT. In Mali, national malaria and RH guidelines did not specify that IPTp-SP should be administered under DOT, however the national malaria guidelines on IPTp-SP and ITNs directed health workers to give prescriptions for IPTp-SP that women take to the medicine depot, where DOT is carried out. In contrast, the in-service training document and the guidelines for supervision in Mali specified that IPTp-SP DOT be provided directly by health workers in ANC clinics.

Four countries had inconsistent or incomplete policies and clinical guidelines about use of IPTp-SP for HIV-positive women. In Mali, the national malaria guidelines correctly recommended three doses of IPTp-SP for HIV-positive women, but did not state that IPTp-SP should not be given if the woman is taking daily CTX prophylaxis. In Mozambique, the RH guidelines and MNH nursing curriculum stated that women on CTX or antiretrovirals should not receive IPTp-SP (antiretrovirals alone are not a contraindication to IPTp-SP). In mainland Tanzania, the FANC Quality Improvement Tool stated that women with CD4 counts <350 cells/mm³ should take daily CTX, and that this should be stopped to give three doses of IPTp-SP, which conflicts with WHO guidelines. Finally, in Uganda, only one of four documents provided guidance on use of IPTp-SP for HIV-positive women, but did not discuss withholding IPTp-SP for women on CTX prophylaxis.

All country documents recommended counselling pregnant women on the use of LLINs as early as possible in pregnancy, some specifying at the first ANC visit, but no country provided consistent guidance about how nets should be distributed, or how women can obtain them. While the supervision guidelines in mainland Tanzania recommended that providers give vouchers to women to subsidize the purchase of bed nets, the process is not clearly described in policies and guidelines. The malaria guidelines from Mozambique, and most documents from Kenya, Mali and Uganda recommended distribution of LLINs free of charge at the first ANC visit, but no specifics are given on who should provide them. It is also possible that LLIN promotional materials existed in these countries and were not captured in the documents reviewed, thus net voucher programmes or distribution campaigns might be established and operated outside health facilities and somewhat independent of national programmes.

Three countries had guidelines that were conflicting, inconsistent and/or incomplete when compared with the other documents from the country and with those from WHO about the need for diagnostic confirmation of clinical malaria with microscopy or RDTs. For example, Kenya’s malaria guidelines, one in-service training package and the supervision documents recommended parasitological diagnosis for all pregnant women reporting fever prior to treatment, while the second in-service training package did not mention testing prior to treatment. In Mozambique, the RH policy did not mention diagnosis, while all other documents stated diagnostic confirmation is required prior to treatment. Uganda’s malaria policy and guidelines recommend routine microscopy, and not RDTs, but also recommended that any pregnant woman presenting with fever be treated for malaria, even if the blood smear is negative. On the other hand, the malaria policy and in-service training material stated that either microscopy or RDTs should be available and used in all facilities. All of Mali’s and mainland Tanzania’s documents recommended parasitological confirmation of malaria before beginning treatment.

While four of five countries had at least one document that described treatment, specific to trimester of pregnancy and severity of infection, including drugs and their doses, none of the countries reviewed had consistent or complete treatment guidelines across all documents (Table 5)^c. Kenya’s national malaria guidelines provided information, consistent with WHO treatment guidelines, for drugs and their doses by trimester for uncomplicated and severe malaria, but the two in-service training packages and supervision document provided incomplete, albeit consistent, information. None of Mali’s treatment guidelines stated the drug or dose according to trimester of pregnancy or severity of infection. Mozambique’s guidelines from both malaria and RH programmes contained complete, consistent treatment information, but the two in-service training packages and the MNH standards gave incomplete information. Uganda’s in-service training packages are the most complete, while the others lack information on drugs by trimester and severity of infection. Often they refer to guidelines for treatment of adults which did not always address the issue of treatment by trimester. Malaria guidelines in all five of the countries recommended parenteral quinine for severe malaria in second and third trimesters, instead of the WHO-recommended first-line drug, parenteral artesunate.

Policy and guideline documents often provided conflicting and inconsistent information about use of IPTp-SP and restrictions on its timing. Four countries had out-of-date guidelines in terms of when IPTp-SP can be given, limiting opportunities to provide it, and contributing to low IPTp-SP coverage rates. Health care workers trained using these guidelines are placed in a position of not knowing whether to provide IPTp-SP between 16–24 weeks, as well as after 32 weeks, potentially shortening the window of opportunity to between 24–32 weeks. Since SP must be given no more often than monthly, few women in Mali’s system are likely to receive two doses of IPTp-SP at no more than monthly intervals during their pregnancies.

One challenge to implementation of the updated WHO recommendation for IPTp-SP is reassuring health workers that IPTp-SP can be given safely after completion of the first trimester, starting at 13 weeks of pregnancy, and up to the time of delivery, as long as doses are at least one month apart. Many guidelines recommend waiting until at least 20 weeks of pregnancy before giving the first dose of IPTp-SP. Countries should consider revising their policies and guidelines to recommend that all pregnant women receive their first dose of IPTp-SP starting at 13 weeks of pregnancy. All documents should utilize weeks, not months, of pregnancy to describe timing of IPTp-SP as they may not be understood in the same way. Country guidelines currently use terms such as “16 weeks or after quickening,” but because quickening may occur much later than 16 weeks, particularly in primigravid women, this can be a source of additional confusion. Provision of care will improve if health workers clearly understand in which specific week of pregnancy the first dose of IPTp-SP should be given. In addition, many guidelines recommend avoiding IPTp-SP in the last four weeks of pregnancy. The earliest WHO recommendations for IPTp recommended withholding IPTp during the last four weeks of pregnancy due to a theoretical risk that severe neonatal jaundice may be increased if sulfa drugs are provided near the time of delivery; however, this was unfounded, and the recommendation to withhold IPTp late in pregnancy was removed from the guidelines in 2004 [17]. Country policies should be updated to reflect these recommendations. In addition, ANC cards and registers may need to be updated so that health workers can easily document and monitor use of IPTp-SP.

While malaria control programmes provide technical guidance, MIP prevention activities are implemented by RH divisions through ANC. Failure to provide correct, consistent and complete MIP guidance in malaria and RH documents can lead to formulation of training and supervision documents and job aids that contain incomplete and/or conflicting information, resulting in confusion among ANC providers as to when IPTp-SP may be administered safely [10]. Thus pregnant women either may not receive services to prevent malaria, or services may be provided incorrectly. Conflicts and inconsistencies between RH and NMCP documents are difficult to prevent. Programmes update their documents at different intervals, based on programme-specific needs. Improving uptake of MIP interventions requires continued or renewed leadership from RH programmes, with technical support from NMCP and HIV control programmes. Until all of these programmes collaborate to formulate policies and guidelines for MIP prevention and treatment, discordant documents will continue to be issued within countries.

Since 1998 WHO has recommended daily doses of 0.4 mg of folic acid, which can be provided concurrently with SP, without compromising the efficacy of IPTp-SP. Interruptions in folic acid use can cause confusion for women about when to resume the folic acid, or may simply result in providers not prescribing IPTp-SP as they do not wish to disrupt folate administration. Countries should ensure as soon as feasible that the lower 0.4 mg dose of folic acid is provided to pregnant women. The change in folic acid dose and provision will require additional training and formulation of clear guidelines to health workers who are accustomed to counselling women to stop folic acid intake for periods of up to two weeks after receiving IPTp-SP.

Guidelines from national HIV/AIDS control programmes were not reviewed, but across the five countries there are conflicting, inconsistent and/or incomplete guidelines from malaria control and RH programmes regarding malaria prevention for HIV-positive pregnant women and the contraindication to co-administration of CTX and IPTp-SP. Particularly, in light of updated WHO recommendations for prevention of mother-to-child transmission of HIV [18], all documents relating to malaria, RH and HIV should be updated to ensure correct and consistent guidelines about use of IPTp-SP for HIV-positive women; providers should be aware that while women taking CTX should not receive IPTp-SP, they still need to be encouraged to use LLINs. HIV-positive women not taking CTX should follow the same schedule of IPTp-SP use as HIV-negative women, since the updated WHO policy document recommends frequent dosing for all women. Revision of these documents should include representatives from the NMCP, RH programme, and HIV control programme so that prevention and treatment of MIP for HIV-positive pregnant women is clear for all health workers.

Although most countries’ malaria and RH policies and guidelines recommend use of LLINs as early as possible in pregnancy, ideally at the first ANC visit, there is little or no information about when and how pregnant women are to obtain them. While some countries provide vouchers to women to subsidize their purchase, the process is not clearly described in policies and guidelines. In countries where women must purchase LLINs without vouchers, health workers need to know how to correctly inform women about when and where to obtain them. LLIN procurement and access to LLINs for pregnant women are particularly critical given the vulnerability of pregnant women and the fact that this is the only method of prevention available to pregnant women in the first trimester. Countries should make consistent recommendations about counselling of women on use of LLINs, as well as how nets are distributed. Ideally, LLINs should be given to all women, free of charge, at the first ANC visit, and this should be documented on the ANC card and register. Each country should clearly describe the mechanism for distribution, i.e. who in the ANC clinic is responsible for ensuring that the woman receives the net, or if vouchers are used, who provides the voucher and what instructions should be given about where and how to redeem them. In addition, countries should ensure that effective procurement and management practices prioritize adequate stocks of LLINs at ANC to give pregnant women consistent access and greater opportunities for coverage.

WHO recommends parasitological diagnosis whenever possible, yet many country guidelines are not correct, consistent or complete in recommending diagnosis of MIP with RDTs or microscopy prior to treatment. Treating all pregnant women with fever for presumed malaria can lead to over-treatment, exposure of the foetus to unnecessary medications and misdiagnosis of other causes of febrile illness. Although all country guidelines indicated the drugs to be used, many did not specify drug doses, nor did they state which drugs to give according to trimester of pregnancy or severity of infection. All clinical guidelines, educational materials and pertinent job aids should stress the need for parasitological diagnosis of MIP prior to treatment whenever possible. Clear algorithms—complete with correct drugs, doses, timing by trimester and by severity of infection—should be developed and used consistently in all documents and educational materials. User-friendly job aids that reflect these algorithms should be developed and distributed widely.

Most of the concerns mentioned above could be addressed by establishing a national technical working group (TWG) for MIP, comprised of leaders from the divisions of malaria, RH and HIV. Other key members should represent the departments responsible for laboratories/diagnostics, medical stores, pre-service and in-service education, health management information and monitoring/evaluation. The importance of TWGs across countries is well documented [19,20]. They provide an important mechanism not only to harmonize efforts, but also foster partnerships and create a working environment to coordinate and support programme implementation.

The TWG should identify and address gaps in the health system that are precluding uptake of IPTp-SP and LLINs in ANC clinics. Ideally, all elements of ANC should be scrutinized to ensure that women receive the complete package of services along with LLINs and IPTp-SP in an integrated manner. The TWG should engage all programmes linked with MNH to formulate a comprehensive checklist of services that every ANC clinic is responsible for providing and documenting. Ideally, RH programmes should lead the implementation of all interventions, including MIP, that ensure healthy outcomes for pregnant women and their newborns throughout the continuum of care, with technical oversight for MIP from the malaria control programme. It is important that NMCP inform RH colleagues of new or pending changes in malaria policies and guidelines so that RH documents reflect these in a timely manner. Policies and guidance documents for all ANC services, including MIP prevention and treatment, should be formulated jointly by NMCP, RH and related programmes in each country, so that inconsistencies can be averted. On a global level, WHO can ensure collaboration between the Department of Maternal, Newborn, Child and Adolescent Health and the Global Malaria Programme as new ANC guidelines are developed.

This review has some limitations. Not all documents requested from each country were available, and formal measurement was not done of how these national level documents affect implementation of MIP programmes. In addition, the convenience nature of our sample restricted the review to countries where at least some formal policy documents were reasonably available. As a result, the MIP policy situation in these five countries may be better than is typical across the rest of the malaria-endemic countries. As noted, information specific to MIP prevention or management may exist in documents outside those produced by the NMCP and RH programmes (such as guidelines for programmes implemented to prevent mother-to-child transmission of HIV), which would not have been considered in this review.