Recruitment; The M-MAMA Champions will be identified and recruited from clusters that will be randomized to the intervention arm. The exact source of M-MAMA Champions will be the M-MAMA database which is housed at the President’s Office of Regional Administration and Local Government and the health facilities in the respective clusters. The database contains the client’s details of the referring and receiving health facilities to which the client attended and the date of the referral. It is presumed, that the contact details will be obtained at the referring health facility through health facility records.
The inclusion criteria of M-MAMA Champions, those aged 15 to 49 years, at least 3 months post-delivery, primary education, ready, and volunteering to empower other women (23).
The selected M-MAMA Champions will be contacted via phone call and requested to participate in the study, followed by physical contact, whereby the consent form will be presented for them to sign. It will then be followed by the collective orientation of the package to be used for empowering pregnant women with knowledge of obstetric danger signs, birth preparedness, and complication readiness (24). A simple random selection of three (3) M-MAMA Champions per cluster will be done, among those who will have attained a minimum competence score after the orientation.
Training Package Customization; The Tanzania Ministry of Health package or module on basics of reproductive, maternal, new-born, child, and adolescent health for community health workers, which contains 18 sessions will be adapted and customized based on the study requirements (ODS, BP &CR) to suit the intended intervention to the target population. The package will be customized through an extraction of the specific sessions; whereby other unintended contents won’t be included. It will be followed by the review of the newly customized package by the experts for comments, which will be worked up accordingly. The proposed package will be translated into Kiswahili, which will also be reviewed by the experts for comments on the understanding, language of the target group, and the friendliness to the readers, this will involve also experts from the Ministry of Health.
Orientation of M-Mama Champions; The community engagement through M-MAMA Champions is a devised intervention to empower other pregnant women by M-MAMA Champions after being oriented on the sensitization package. The orientation will be done by the researcher. After the orientation, the competence test will be taken by the M-MAMA Champions, and those who score an average score and above will be eligible to be involved in the study to deliver the intervention. The orientation package will entail the obstetric danger signs, birth preparedness, and complication readiness.
Roles of M-Mama Champions
The M-MAMA Champions after being empowered, will be carrying out the following duties. Creating awareness of the obstetric danger signs, and birth complication readiness and encourage for their practice. Each M-MAMA Champion, will be assigned and be responsible for empowering at least five (5) pregnant women, for a period of one month, she will hold a total of three sessions at an interval of two weeks. The sessions will be held at one of the pregnant women premise upon their agreement whereby all the pregnant women will come together, and have a sensitization session and the M-MAMA Champion will be a facilitator. Each sensitization session is devised not to exceed two (2) hours (24).
Recruitment of Participants
The recruitment of participants from the target population (pregnant women) from the study area will be as per the inclusion and exclusion criteria. The list of pregnant women from the selected clusters (villages or streets) will be developed from both the community health worker of the respective village or street and health records from the nearby health facility. 15 pregnant women will be studied per cluster, be it an intervention or control arm. Therefore, a pre-determined number of pregnant women per cluster will be obtained through random selection through a random number generator from the pregnant women list within the cluster. Physical visits to the pregnant women will be done and request them to participate in the study, obtaining the informed consent and followed by the baseline data collection.
The study population for this study will include pregnant women who will be available in the study area during the study period.
Inclusion criteria; pregnant women in the first and second trimester (up to 28 weeks of GA).
Exclusion Criteria; include pregnant women; who will be sick and admitted, mentally incompetent, and those who won’t consent to participate in the study.
Randomization
The randomization will be done through simple randomization at the ward level. Each ward will consist of two villages/streets (clusters) with a pre-determined number of 15 pregnant women each as per inclusion criteria. Four (4) wards will be randomized to either the intervention or control arm at a ratio of 1:1 through a computerized random number generator that will be done using excel. Allocation sequence will be generated by the statistician by stipulating clear assumptions for each arm allocation from computer, followed by the cluster’s assignment to specific arms. This will ensure an equal opportunity for all the study participants within clusters to be randomized to either the intervention or the control groups, reduce contamination, and ensure baseline covariates balance between study arms.
Intervention Arm; Those study participants randomized to the intervention arm will receive the intervention being tested in this study. The intervention will be community engagement that means creating awareness using the M-MAMA Champions on ODS, BP & CR to pregnant women. The sensitization package will be in a form of a brochure encompassing of obstetric danger signs, birth preparedness, and complication readiness, will be adapted from the Ministry of Health, Tanzania. The package source is being used to empower Community Health Workers (CHWs). The sensitization is designed to take place at one of the pregnant women residential areas, whereby the assigned group of pregnant women ranging from four (4) to eight (8) with one M-MAMA Champion as a facilitator will gather up for a period of not more than two (2) hours per session to a total of three (3) sessions to discuss about the package and their practice implication. The intervention is expected to be delivered in four (4) Clusters for a period of one month from March to April 2024 and raise awareness by at least 20% in the intervention arm within a study period.
Control Arm; The study participants who will be randomized to the control arm won’t receive the intervention, instead, they will continue receiving the routine services. The routine services for pregnant women specifically on knowledge-related empowerment include the package delivered by the healthcare workers at the reproductive and child health clinics. The package is delivered during every ANC visit to the pregnant woman. The package contains basic information that is also tailored to the specific needs of pregnant women and is delivered with much emphasis to those who are prone to experience pregnancy-related complications for instance, those with Bad Obstetric History (BOH), cardiovascular diseases, or diabetics.
Intervention Implementation Fidelity; Several strategies have been put in place to ensure intervention implementation fidelity in this study. The strategies include; the researcher, two research assistants, and one Community Health Worker (CHW) from each village/street will pay close observation to the implementation of the intervention. M-MAMA Champions oriented before the intervention, a standard and valid intervention package adapted from the Ministry of Health, Tanzania. Blinding will be done to the statistician who will assist with data analysis, research assistants who will help with baseline and end line data collection and the study subjects themselves.
Primary outcome
Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women. Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on the awareness of the obstetric danger signs. It's anticipated that there will be a positive change in scores after the four (4) weeks of intervention.
Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women. Change of pregnant women's scores from a semi-structured interviewer-administered questionnaire on awareness of birth preparedness and complication readiness after the intervention. It's anticipated that the majority will be able to name at least three (3) of five (5) key elements of birth preparedness and complication readiness after the four (4) weeks of intervention.
Secondary Outcome
Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness. Change in the scores from a semi-structured interviewer-administered questionnaire on the reported practice of birth preparedness and complication readiness among pregnant women after the four (4) weeks of intervention. the intervention.
Sample Size Estimation and Sampling Technique
Sample Size Estimation; The study will assess the effect of the M-MAMA champions in providing health education on obstetric danger signs whereby, the difference in the average in knowledge among pregnant women will be compared before and after the intervention. The sample size estimation formula as recommended by (25) Therefore, the sample size is as highlighted below
The total sample size per arm plus a 20% attrition rate is 60
The study assumes a significance level of 5% and a power of 80%. The study subjects will be randomly allocated at a ratio of 1:1, therefore 60 subjects for the intervention arm versus 60 subjects for the control arm will be studied. Under this study, each cluster will constitute 15 subjects. Therefore, the intervention arm will have four (4) clusters, as well as the control arm making a total of eight (8) clusters.
Sampling Technique; Multistage sampling technique will be employed for the selection of the study subjects for both the intervention and the control group. The first stage will be done through a simple random sampling through the lottery method of four (4) out of twenty-two (22) wards in Bahi District Council. It will be followed by the simple random sampling of two villages/streets from each ward, making a total of eight (8) clusters. The study subjects from each cluster will be randomly selected from the developed list of those who meet the inclusion criteria so as to meet the pre-determined number (15 subjects) per cluster. Therefore, a total of 120 subjects will be selected for the study.
Variables and Variables Measurement
Variables Definition; Pregnant women demographic characteristics and community engagement through M-MAMA Champions are the independent variables. The dependent (outcome) variables includes awareness on obstetric danger signs, birth preparedness and complication readiness among Pregnant women which are the primary outcomes and practice of birth preparedness and complication readiness is the secondary outcome.
The obstetric danger signs referred in this proposal are those which occur during pregnancy which includes; - Abdominal pain, severe fatigue, vaginal bleeding, fever, difficulty in breathing, persistent headache, blurring vision, swelling/oedema of hand, face or feet, foul smell vaginal discharge, unconsciousness, convulsion, reduced foetal movement and pallor.
Birth preparedness and complication readiness encompasses of five (5) key components which includes; 1) Identification of the place to give birth, 2) Identification of a potential blood donor, 3) Identification and selection of a skilled birth attendant, 4) Identification and selection of means of transportation in case of an emergency and 5) Saving money for emergency transportation(28).
Variable Measurement; An independent variable, demographic characteristics will be measured by three items (age, parity and gravidity) on a numerical scale, four items (place of residence, occupation, marital status and religion) on a nominal scale and one item (educational level) on an ordinal scale.
The dependent (outcome) variables; Awareness on obstetric danger signs will be measured by eight (8) items on a binary scale. One point will be awarded for the correct answer and zero for the wrong answer. A total score will be eight (8), a mean score will be computed whereby those who will score above the mean will be considered to be aware and have good knowledge whereas those who will score below the mean will be considered to be unaware and have poor knowledge(29).
Awareness on birth preparedness and complication readiness (BP & CR) will be measured by five (5) items on a binary scale. One point will be awarded for the correct answer and zero for the wrong answer. A total score will be five (5), those who will be able to mention/identify at least three (3) out of five (5) BP & CR components will be regarded as being aware and have adequate knowledge on BP & CR(30).
Birth preparedness and complication readiness practice will be measured by five (5) items on a binary scale. One point will be awarded for the accomplished practice and zero for non-accomplished practice. A total score will be five (5), whereby those who will have accomplished at least three (3) out of five (5) birth preparedness and complication readiness factors will be regarded as having good practice of birth preparedness and complication readiness(30).