Introduction
Prenatal iron supplementation has been the customary recommendation in addressing maternal anemia especially in developing countries for over thirty years (West, et al., 2014). There is paucity of information regarding the correspondence between hemoglobin levels in pregnant women and iron supplementation. The limited information in this pertinent public health issue is more pronounced in developing countries as West, et al., (2014) opines. The main purpose of this research is thus to establish the efficacy of prenatal iron supplements on the hemoglobin levels of pregnant women in developing countries.
Research design
In order to achieve the study’s objective, the methodology will pool data from randomized control trials in the select study area. Meta-analysis of these data will then be conducted.
Study population
The study will be carried out in Kenya, an East African Nation in Sub-Saharan Africa. The main reasoning behind the selection of the study site is due to the limited information regarding the effect of iron supplementation on maternal outcomes. Additionally, there is a high prevalence of anemia among pregnant and nursing mothers (Zimmermann & Hurrell, 2007). The study site will be in Nairobi, the capital city of Kenya, where the trial will be carried out. The city has seven districts and a population of 1.2 million people. Most residents are semi casual laborers. The annual per capita income for the population is $300. Consequentially, access to essential prenatal drugs is a challenge.
The trial will be carried out in Nairobi County. Treatment intervention groups will then be selected and separated based on their regions to avoid treatment contamination. Study participants will thus be required to come from the Nairobi city as residents. Random selection will then be done.
Consent will be administered to the selected participants and consenting participants will be categorized based on their pregnancy.
Inclusion criteria:
Women aged above 16 years conformed to be pregnant and at <16 wk gestation. The women will have to be registered at the local community health facility.
Exclusion criteria:
Women with high risk pregnancy with a positive confirmation of the same using ultrasound. Women with a pertinent medical condition will also be excluded from the study. Such conditions include severe anemia with an Hb level below 80g/l.
Methodology or procedures
After obtaining a written consent from the study participants, which will be signed or a thumb print provided for the illiterate women, the constituted research team will proceed to obtain their demographic information. Demographic information is vital for follow up studies.
The maternal venous blood will also be obtained so as to check for iron and hemoglobin index (the transferrin and ferritin) at the point of enrollment for the study. The pregnant women’s serum folate and Vit B12 levels will also be obtained including their Serum 25 (OH) Vit D concentration. Additionally, their iodine concentration will also be obtained. Data will be coded to protect participant’s privacy and stored electronically in password protected software.
Measurement of variables
The study will involve three arms of intervention for the categorized (3) three groups.
Group 1.
1 tablet of Iron–folic acid (IFA) will be given daily. This is the recommended intervention given to antenatal women in Kenya.
Group 2.
1 capsule of Iron–folic acid will be administered twice in one week.
Group 3.
1 capsule of MMNs will be given two times a week.
Taking this drugs will proceed until 3 months postpartum. The tablet in group 1 and the administered capsules in group 2 will be identical in form. This is to prevent any bias from the research participants who may pick out the differences in drug composition. In this research however, no placebo will be considered since this is regarded as unethical to withhold therapeutic drugs from pregnant women. The selected drugs will be selected from the local GlaxoSmithKline drug manufacturer for purposes of consistency.
This form of data collection borrows from previous studies conducted analyzing the effect of HB on maternal outcomes. However, this study goes a little bit further by extending the duration of data collection so as to observe more effects. Although this strategy opens doors for compromising the results, it also serves as the only way to gain in-depth analysis on maternal outcomes.
Definitions of variables
The dependent variable in the study will be iron supplements. Coding of this variable will involve using the constituents of the active ingredients. This includes the mgs of the elemental iron, the amount of folic acid per tablet or capsule and how it is administered. For instance, for the first group, (50 mg of elemental iron, 0.5 mg of folic acid per tablet given daily)
This variable will be measured against independent variables including the primary measure of hemoglobin levels (Hb). Ferritin levels will also be measured 32 weeks post-partum.
Statistical analysis
At this point, you may not know enough to decide on statistical tests, but be sure to describe the comparisons you will make to arrive at your conclusions.
Statistical will be done by computing logistic and linear regression for dualistic outcomes. In the case of Hb and ferritin, linear regression models will include the measurements taken at baseline which be a covariate. Additional statistical inferences between the independent and dependent variable s will be done using Stata v.11.2 (Stata Corp)
Strengths of the study
The main strength of the study is that, it is among the few studies conducted that measures the effect of taking iron supplementation on maternal outcomes, specifically, hemoglobin levels. By gaining this understand, anemia incidences in pregnant mothers is bound to be reduced especially in developing countries.
Limitations of the study
A major limitation of the study will be the presence of numerous confounders which may affect the study’s outcomes. These include other drugs taken by the antenatal mothers and also the nutritional uptake postpartum which may affect the hemoglobin levels.
Project Timeline
April through May 2016:
Proposal writing
Questionnaire development
Prepare ethical and scientific approvals
Prepare consent forms
June and July:
Conduct the pilot study
Develop and test questionnaire
Adjust questionnaire and address any ethical issues from the pilot study
August and September:
Obtain relevant local authorization
Present consent forms
October and November:
Data entry and data management
Data analysis
December and January 2017:
Complete write-up of final report
References
West, K. P., Shamim, A. A., Mehra, S., Labrique, A. B., Ali, H., Shaikh, S., & Hanif, A. A. (2014). Effect of Maternal Multiple Micronutrient vs Iron–Folic Acid Supplementation on Infant Mortality and Adverse Birth Outcomes in Rural Bangladesh: The JiVitA-3 Randomized Trial. JAMA, 312(24), 2649-2658.
Zimmermann, M. B., & Hurrell, R. F. (2007). Nutritional iron deficiency. The Lancet, 370(9586), 511-520.
