The study was conducted in Asmara, Eritrea at all the health facilities that provide maternal health services, including delivery, one hospital and other three health facilities were selected for the study to represent the city.
Eritrea is situated in the horn of Africa bordered by the Sudan, Djibouti, Ethiopia and the Red Sea with 1,212 Km seashore. It covers an area of 124,000 sq. km and is divided into three topographic areas (the Western Lowlands, the Central Highlands and the Coastal Plains). Administratively, it is divided into 6 regions or zones, namely Southern Red Sea Zone, Northern Red Sea Zone, Anseba, Gash-Barka, Southern Zone and Maekel (Central Zone). The total population are about 6.1 million . Asmara is in central region (Zoba Maekel), country’s capital city, is the targeted area of the study.
Study Design, Study Population and Sample Size:
The study was designed as cross-sectional laboratory based study. That comprises all pregnant women living in the Catchment area of Asmara administration, in the reproductive age group of 16 to 45 years [14,15].
The data was collected between July and August 2016 from 210 pregnant women (in four health facilities) whom attending their ANC follow up. Voluntary sampling technique, was implored following their consents and agreements to participate in the research study.
Data Collection Tools and Techniques:
A structured questionnaire was used to collect the pregnant women demographic information and the other associated risk factors in the study. Pregnant women were interviewed by the enumerators which were health professionals who works in the facilities where the collection had been conducted.
Collection of sample and Laboratory investigation:
A three ml venous blood sample was collected from study participants using standard procedures on Lithium heparin container and was stored in freezing condition (-200c) before analysis. Serum was prepared by centrifugation of blood at 2500 rpm for 3 minutes.
The electrochemiluminescence immunoassay (ECLIA) was used for in vitro quantitative determination of IgG and IgM antibodies to Toxoplasma gondii in human serum on Elecsys and Cobas e411 immunoassay analyzers.
Quality control (QC):
For QC; Preci Control was used. Controls for the various concentration ranges were run every day when the test in use and following each calibration. Based on the measurements of cal-1 and cal-2 the cut-off was calculated automatically.
Interpretation: IgG: >1 (non-reactive), > 1.0 - > 30 (Intermediate), > 30 (Reactive).
IgM: > 0.8 (non-reactive), > 0.8 - >1.0 (Intermediate), >1 (Reactive).
Data entry and Data Analysis:
Questionnaire completeness checking process was followed by data entry into computers using Epi-Info (V 7.0), free software package developed by CDC. To describe the data in terms of frequency and proportion SPSS (V 20.0) computer program was used . To describe the age of participants, which is continuous variable, average and standard deviation were used . In this study, the chi-squared test has been applied to screen for an association between IgG and IgM antibodies seropositive results and the several risk factors included in the study .
Ethical Issues; Informed Consent and Confidentiality:
Research approval for the study was obtained from Research and Ethic Committee, Faculty of Medical Laboratory Sciences, University of Gezira. Based on the request of Faculty of Medical Laboratory Sciences, University of Gezira, the Health Research Proposal Review and Ethical Committees, MOH Eritrea had accepted and gave a permission to conduct the research on the specified sites. Ethical Permission was obtained from the Ministry of Health, Zoba Makel.
Participants were briefed about the aim of the study and requested their willingness to participate in the study. The interview was carried out face-to-face to obtain information and were kindly asked for their enthusiastic participation and sign on the prepared consent form.