Anemia is a condition characterized by a reduction in the number of red blood cells or a drop in hemoglobin levels, which prevents oxygen from being carried to organs and tissues. According to the World Health Organization (WHO), the hemoglobin (Hb) threshold for anemia is below 11 g/dl for pregnant women in developed countries, and below 10 g/dl in developing countries [1] [2] [3] . Around one in four women conceives with insufficient or absent iron stores, with serum ferritin levels below 30 mg/l. These levels are insufficient to meet increased iron requirements during pregnancy, childbirth and the postpartum period [4] . The global prevalence of anemia is 24.4%, and an estimated 2 billion people suffer from anemia [3] [5] . According to the World Health Organization (WHO), the prevalence of anemia among women of childbearing age in sub-Saharan Africa is 57.1%, but this varies from region to region, with the highest level recorded in Central and West Africa (61%) and the lowest in Southern Africa (34%) in 2011. Although the authors report a downward trend from 1995 to 2011, the anemia is found in 38% of pregnancies (32.4 million) worldwide [6] , with a prevalence of 14% in developed countries and 51% in developing countries [7] [8] . This prevalence is more marked in sub-Saharan Africa, due to a lower intake of iron and other micronutrients before and during pregnancy [9] . In the DRC, especially at the University Clinics of Kinshasa, the reported frequency of anemia during pregnancy has varied from 52.2% to 53.4% [10] [11] . Anemia is a public health problem mainly affecting developing countries [12] . Anemia can be attributed mainly to nutritional deficiency, particularly iron deficiency, which predominates during pregnancy, and is associated with parasitic diseases such as malaria and intestinal parasitosis, acute or chronic diseases such as sickle cell disease, tuberculosis, HIV infection and various micronutrient disorders [13] [14] [15] [16] . Anemia contributes to 23% of maternal mortality (MM) worldwide and is directly responsible for more than 3% of severe MM in Africa [17] [18] [19] . Maternal anemia during pregnancy, particularly from the second trimester onwards, influences the infant’s postnatal growth and is associated with an increased risk of low birth weight, prematurity and may contribute to impaired cognitive development in early childhood. The impact on the fetus is even greater when maternal anemia onset is at an early stage, or even prior to pregnancy [20] [21] . Management of anemia during pregnancy is twofold: preventive, involving exclusively exogenous iron supplementation combined with blood and intestinal cleansing; and curative, involving either oral iron in the form of iron salts, parenteral iron in the form of sugar-bound injectable iron, or blood transfusion, depending on the severity of the anemia [22] . It is well known that iron supplementation in pregnant women improves hematological values and helps prevent complications [23] . The beneficial effect of iron supplementation has been shown to depend on iron dose, duration of use and initial Hb concentration before treatment [24] . Iron salts, such as sulfate or fumarate, have been widely used, but due to gastrointestinal side effects, many patients frequently decide to stop taking them [25] . This is why a multi-component sodium iron EDTA, which allows high absorption and bioavailability, has become available on the Congolese market. It appears to be free from the usual iron-related side effects (metallic taste and gastrointestinal troubles). Several studies have evaluated these beneficial effects, including clinical trials involving pregnant women with iron-deficiency anemia, which demonstrated the superiority of sodium iron EDTA over ferrous sulfate in balancing blood parameters and improving quality of life [26] [27] , while a study in India comparing sodium iron EDTA and ferrous fumarate showed that low doses of sodium iron EDTA improved Hb levels without adverse effects, making sodium iron EDTA an effective treatment for anemia in pregnant women [26] . Measurements of serum iron, ferritin and transferrin are the best markers of iron status. In developing countries, on the other hand, where access to healthcare is difficult due to low socio-economic status, Hb measurement is often used [28] . Hemoglobin is an ideal parameter for indirectly identifying iron levels, due to its strong correlation with serum ferritin levels or the presence of genetic alterations in the human hemochromatosis (HFE) protein gene. This paraclinical parameter is relatively fast and easy to perform and is already routinely used in standard clinical practice during pregnancy [25] . In DR Congo, given the poverty of our population, iron supplementation is still the order of the day and occupies a predominant place for pregnant women, compared with other environments where they have found a way of short-circuiting oral iron by administering it parenterally. To avoid treatment discontinuation due to other forms of iron, it is important to know whether sodium iron EDTA can offer particular advantages, as described in the literature, or also in our setting with regard to the characteristics of our population. This is why we initiated the present study.

This study will evaluate the evolution of hemoglobin levels after supplementation with sodium iron EDTA at the university clinics of de Kinshasa, to determine the frequency of gravidic anemia, the dose-dependent benefit of sodium iron EDTA supplementation in pregnant women, and to identify factors associated with insufficient hemoglobin gain after supplementation.

Anemia is an important determinant of maternal and child health [7] , and to this day constitutes a heavy burden in developing countries [3] . Studies in developed and developing countries have reported frequencies of 39.8%, 83%, 2.49%, 41.6%, 58.8% and 53.4% respectively in Cameroon, India, Portugal, Turkey, Nigeria, and the DRC [11] [29] [30] [31] [32] [33] . Iron salts in the form of ferrous and ferric iron are used in the treatment of anemia of pregnancy. Vijaya et al. demonstrated the efficacy of sodium iron EDTA over ferrous fumarate in the treatment of anemia, and the advantage it provides in significantly improving Hb levels with fewer adverse effects than other forms of iron salts [17] while Han et al. showed that with medium doses of sodium iron EDTA, pregnant women were less likely to develop oxidative stress during pregnancy than those consuming other forms of salt, and significantly improved hematological parameters [27] [34] [35] .

All these aspects will be addressed in our study.

The study will enable us to better assess the benefits of sodium iron EDTA in improving hematological values, as well as its tolerability in pregnant women suffering from anemia during pregnancy in our setting.

MMA and LNN are the principal investigators. MMA generated and designed the study. LNN participated in the study design and will be actively involved in data collection. MMA, LMEP, LAJ, MNF, LBJ, LMEP, KNB, NOC and MFM contributed to the drafting and improvement of the manuscript.

The authors declare no conflicts of interest.

Mbangama, A.M., Lemba, N.N., Lumaya, A.J., Muamba, N.F., Lotoy, B.J., Lukusa, M.E.-P., Kazadi, N.B., Ndesanzim, O.C. and Mangala, F.M. (2023) Cohort Study on Benefit of Martial Supplementation with EDTA Sodium Iron in Management of Gravidic Anemia at the University Clinics of Kinshasa. Open Journal of Obstetrics and Gynecology, 13, 1738-1746. https://doi.org/10.4236/ojog.2023.1310147