Trial Design
This study used a quasi-experimental with pre-test and post-test comparison groups design to evaluate the effect of a health education intervention programme on spousal participation in birth preparedness in Farafenni and satellite villages. This study design was guided by the action points identified during a baseline research done among the target group [13]. The study design is simplified in figure.1.
Population of the Study
The study population were spouses of pregnant women attending antenatal care at the Maternal and Child Clinic of Farafenni during the data collection period. The participants’ inclusion criteria for this study were as follow:
- Spouses of pregnant women attending their antenatal care (ANC) booking at the Maternal and Child Clinic, Farafenni, with a gestational age between 16 to 28 weeks.
- The spouses who came from the villages and Farafenni Wards identified as study sites and planning to stay in the area for at least one month post-delivery of their wives.
- Living with their wives and expected to be present during the pregnancy and delivery periods.
- Ability to speak Fula, Wollof, Mandinka or English language.
- Permission must be given by their pregnant wives to contact them and for their participation. This due to the fact that women should be give the autonomy to choose whether their husbands can be involved in their maternal health care or not. According, WHO, despite the benefits of male partner participation in maternal health care, it should never be a requirement for women to access skilled care thus women should be empowered to make such a decision [5].
However, spouses who met the inclusion criteria but were less than 18 years of age, health-care professionals or studied medical sciences and /or sick or travelled during the time of study participants’ enrollment period were excluded from the study.
Study Setting
This study was conducted at the Antenatal Clinic of the Farafenni Regional Hospital. Farafenni is located in the North Bank East Region of The Gambia and it has both urban and rural characteristics, as well as diverse ethnic distribution. The antenatal booking days for pregnant women attending Farafenni Regional Hospital were Mondays, Tuesdays, and Thursdays. During these days, pregnant women whose spouses met the inclusion criteria were identified through interviews and were counselled on the purpose of the study. The women that agreed for their husbands to participate were given study participation invitation letters to deliver to them. There was no antenatal care (ANC) on Fridays, so these days were chosen as research days. The health education intervention and comparison placebo were conducted in alternate Fridays. Thirty (30) spouses were invited each Friday, and were requested to come without their wives but with their antenatal cards. However, in many instances, not all the invited spouses honoured the invitation to participate or to return for second health education session. The spouses who refused to participate or to return for the second health education sessions were replaced making the health education intervention to extend for six (6) months to achieve the required sample size.
The health education sessions were conducted in two separate rooms, i.e., the Antenatal Examination and the Weighing Rooms, as these rooms were not in use during the intervention days.
Intervention
This section includes a description of pre-intervention activities, activities of the health education intervention and activities of the placebo for comparison as represented below:
Pre-Intervention Activities
Two buy-in meetings regarding the aims and objectives of the study were undertaken with key stakeholders in September 2017 before the commencement of the study. Two types of training were also conducted for the staff of the antenatal clinic, labour ward and blood bank before the starting of the study intervention. The whole site training was given to all the staff including support staff such as general assistants and clerks. The aim of this training was to familiarize staff about the project, to address any concerns, and to identify interested staff to serve as research assistants. This training lasted for 45 minutes. The second component of the training was more intensive and aimed at the research assistants only. Six Community Health Nurses and Midwives were selected as research assistants. Four of the research assistants were from the antenatal clinic whilst the remaining two were from the labour ward. They were given a 90-minute refresher training on a variety of topics including obstetric danger signs, preparation for delivery, involving men in maternal care, basic teaching and counselling techniques, and on the structured intervention protocol.
Health Education Intervention
The health education sessions were conducted by two research assistants (male and female) and the researchers using Wollof, Mandinka or Fula local languages depending on the participants’ preferences. The health education was delivered individually to all the members of the intervention group. There were two health education sessions for each of the spouses in the intervention group as outlined below:
First Health Education Sessions
One hundred and fifty (150) spouses came for the first health education sessions, and each received a 25-minutes face-to-face health education on obstetric danger signs and birth preparedness. Posters with obstetric danger signs and birth preparedness indicators were also shown to the participants during the health talk. Counseling on blood donation was also conducted during the first health education contact with each spouse as blood donation is part of the birth preparedness process. The spouses who consented to donate blood were referred to donate blood to save for emergency during the pregnancy or delivery periods of their wives. Participants were made to understand that the blood donated may be used for other patients if their wives did not need it to avoid expiration, but the Blood Bank Unit would ensure that blood is made available to them when needed. The spouses were also informed of the expected dates of delivery of their wives so that they could make plans for it.
After evaluating their comprehension and reviewing of the main messages, each participant was given a typed list of all the materials required for a clean delivery and A-4 size paper photocopies of the posters with the obstetric danger signs and birth preparedness indicator to take home. Each spouse was also informed on the date of his second session, which was at 36 weeks gestation of his wife. Participants’ contact details and expected dates of delivery of their wives were recorded. These records were reviewed at the end of each intervention day and the participants whose follow-up dates (second health education sessions) were due in the next scheduled date for the intervention group were reminded through phone calls or through letters given to their wives during their normal ANC visits to deliver to them. A record of those who donated blood, and that of their wives were kept in the Blood Donation Unit.
Second Health Education Sessions
A total of 150 participants came for the second sessions and each was given another 25-minute health education on signs of normal labour and importance of institutional delivery care. These topics constituted module two of the health education package. These sessions started with reviewing the main messages of the first health education session. Thereafter, spouses were taught signs of normal labour in order to equipment them with required knowledge needed for them to make early decisions for their wives to seek skilled care when they were in labour. Enquiries were made regarding their level of preparation for the deliveries of their wives and blood donation. Those who reported that they did not donate blood were counselled again and referred to the blood donation unit. They were also informed that the post-test assessments would be conducted immediately after the deliveries of their wives. The health educators summarized the health information on each of the topics covered into talking points as follows:
- Life-threatening conditions can occur during pregnancy and childbirth.
- Obstetric emergencies are unpredictable.
- Every birth should be planned.
- Early identification of obstetric danger signs and birth preparedness prevent delay in seeking skilled obstetric care.
Placebo Activities for Comparison Group
The treatment of the participants in the comparison group was similar to that of the intervention group except that they did not receive the health education messages from the intervention package but were given group counselling on nutrition during pregnancy in the first session and exclusive breast feeding in the second (duration: 45 minutes each). To avoid confusion, this group of participants was informed before the pre-test that the questions that were asked in both the pre-test and post-test were not related to the topics that were discussed in the counselling sessions. The participants from this group were not counselled or sent for blood donation. They were informed that their post-test data would be collected immediately after the deliveries of their wives.
Study Outcomes
The primary outcomes were spousal knowledge of and participation in birth preparedness of their wives. The JHPEIGO prototype questionnaire for monitoring birth preparedness and complication readiness for safe motherhood [16] was adapted and modified to suit the research objectives and target group. The questionnaire measured knowledge of birth preparedness by asking the participants questions about the danger signs of pregnancy and child birth, and resources needed when preparing for a child birth. There were seven items under the sections measuring knowledge. A correct response for each item was scored 1 and the wrong response 0. The percentage of the total score for each participant was calculated. A total percentage score between 0 – 30 was defined as low, 31 – 61 was defined as moderate and 62 – 100 was defined as a high level of knowledge of birth preparedness.
Spousal level of participation in birth preparedness was measured based on the number of arrangements a spouse had made, including (1) acquired the required materials for clean delivery (included, two clean gowns for mother, two clean pants for mother, new packet of pad for mother, two clean buckets with lids, surgical spirit for cleaning baby’s the umbilical stump and a clean wrapper for the baby), (2) saved money for the delivery, (3) donated blood to the blood bank for an emergency, (4) arranged for transportation to the delivery center, (5) made an emergency plan and (6) identified a health facility. Spouses were considered ‘highly’ prepared if more than 3 of these arrangements were reported, moderately prepared if 2 – 3, and if 0 - 1 the arrangement was defined as poorly prepared for the delivery of wife.
Data on the primary outcomes were collected using a research assistant-administered questionnaire method. The study questionnaire was translated from English to three of the major local languages of the community (Wollof, Mandinka and Fulla), with the help of an expert in language translation. To ensure quality, prior to the data collection, six community health nurses and midwives fluent in the three major local languages were selected as research assistants and trained in the administration of the questionnaire. Each data collector was given a sheet containing the basic field protocol. There were two teams of data collectors, one was at the antenatal clinic (with four research assistants) and the other in the labour ward with two research assistants. In each team, one person from the data collectors served as a supervisor. The principal investigators monitored and supervised the overall study, to ensure that the research team adhered to the research procedures.
The pregnant women from the selected villages and wards who came for antenatal booking and were within the gestational ages of 16 to 28 weeks were identified and given study participation invitational letters to deliver to their spouses. The pre-test data were collected from the participants immediately after signing/thumb printing the voluntary informed consent forms. The same questionnaire was used to collect both pre-test and post-test data. The participants’ contact details, expected date of delivery of wife, and follow-up appointment dates were noted.
The first follow-up of the participants was at 36 weeks of pregnancy of their wives during which no data was collected. The second follow-ups were used to collect the post-test data. These follow-ups were conducted in the labour and postnatal wards, immediately prior to discharge of the participants’ wives after delivery by the two research assistants working in the labour ward. The post-test data of those who did not accompany their wives to the health facility for delivery, or those whose wives delivered at home, were collected within two to three weeks after the delivery of their wives. To minimize loss to follow-up, participants who did not turn up after an invitation were contacted through phone calls or home visits.
The completed forms from the field were reviewed daily and on-the-spot feedback was provided, with follow-up/callback undertaken, where needed. The data of pre-tested participants who did not participate in the post-test were not included in the analysis in order to eliminate attrition bias.
Sample Size Determination
Using the formula for calculating a sample size for experimental designs by Charan and Biswas [14] (2013), a sample of 298 randomly selected spouses was required to detect a 15% increase in birth preparedness (the minimum justifiable effect size), and power of 80% at type 1 error of 5% as shown below:
Sample size
P = proportion of Institutional delivery = 44% of Farafenni [3].
Zα/2 = Zo.o5/2 = Zo.o25 = 1.96 (from the Z table at type 1 error of 5%)
Zβ = Z0.20 = 0.842 (from the Z table at 80% power)
d = design effect size (mean differences between intervention and comparison) = 15% increase in birth preparedness among experimental group [15].
Sample size participants in each group
10% of the calculated sample size was added to make up for attrition.
The required number of participants in each group = 10/100 x 135 = 13.5 + 135 = 148.5
Therefore, 149 participants were needed in each group making a total sample size of 298. However, this was increased to 300 participants.
Randomization
A multistage sampling method was employed to select a representative sample as shown:
Stage 1: Selection of Villages and Wards
Farafenni Regional Hospital’s Maternal and Child Health Care Catchment Area was divided into rural and urban areas. The rural area was further divided into 12 villages, namely, Macca Farafenni, Yallal Ba, Dutabullul, Gigimarr, Jerri Kaw, Sagab, Kerr Sulay, Kunjo, Elliyasa, Kerr Madi, Kohen Bereto, and Sabach Nyen. The names of these 12 villages were written on pieces of paper, folded, put in a container which was closed and shaken several times to ensure a good mix or randomization of the pieces of paper. Six of these pieces of paper with the names of different villages were randomly withdrawn from the container using the balloting by replacement method. These six selected villages were Macca Farafenni, Dutabullul, Yallal Ba, Kunjo, Kohen Bereto, and Sabach Nyen.
The urban area, which is Farafenni, was divided into four wards and two of them, namely, Farafenni Mauritani, and Farafenni Ballangharr, were selected using random sampling as in the selection of the villages.
Stage 2: Selection of intervention and comparison sites
Selected villages and wards were divided into intervention and comparison sites using random sampling with replacement method similar to what was done in the first stage. In order to ensure that the intervention and comparison sites are not too near to each other (to reduce the risk of social contacts between the members of the two groups), the balloting was done in such a way that there was always a non-study site between an intervention and a comparison site. Farafenni Mauritani, Yalla Ba, Kunjo and Sabach Nyen were the intervention sites whilst Farafenn Ballangharr, Macca Farafenni, Dutabullul and Kohen Bereto were the comparison ones.
Stage 3: Selection of Participants for Intervention and Comparison Groups
Women from the selected six villages and Farafenni town wards meeting the eligibility criteria (they were sent for pelvic ultrasound to confirm their gestational ages) were identified during antenatal booking. Three hundred (300) spouses of these identified women were purposively selected and sent letters inviting them to be study participants. The selected spouses from the villages and ward identified as the intervention sites who agreed to participate were enrolled as the intervention group, while those from the comparison sites were the comparison group. Spouses that rejected the invitation were noted and replaced randomly until the required sample size was achieved in both groups (see figure 2 for detail).
The Principal Investigator was responsible for the randomization but the research assistants enrolled the study participants, and assigned them to the intervention and comparison groups. It was only the study participants who were blinded. Blue stickers with the study identification number of the participants were pasted on the antenatal cards of the wives of spouses in the comparison, whilst green coloured stickers were for those in the intervention group. However, they were not informed on the group that they belong and participants from the intervention and comparison groups were not living together, that is, they came from different villages and Farafenni town wards. In addition, participants of the intervention and comparison groups were invited to participate in the study in different days, that is, in alternate Fridays so that they don’t meet.
Statistical Methods
IBM Statistical Package for Social Sciences (SPSS) version 21 software was used for data analysis. Descriptive statistics were used to summarize the socio-demographic and outcome variables. The differences in the socio-demographic variables between those in the intervention and comparison groups were examined using either independent-samples t-test (for continuous variables), or chi-square (for nominal/grouped variables).
The variables on knowledge of obstetric danger signs and birth preparedness indicators were analyzed by assigning a score of 1 to each correct answer and 0 to each wrong answer given by an individual participant. The proportion of participants that gave a correct answer to each item during the pre- and post-tests were calculated by representing the sum of the correct answers as a percentage of the total. The mean knowledge score differences between the pre-tests and post-tests of both groups (i.e., between groups differences) were tested using the independent sample t-test and at statistical significance level of p < 0.05).
Spousal level of participation in birth preparedness was analyzed by a assigning a score of 1 to each indicator of the birth preparedness items that each participant reported participating in or 0 if he did not participate. The percentage of participants that reported participating in each item during the pre- and post-tests were calculated. Spouses were considered ‘highly’ prepared if more than 3 of these arrangements were reported, moderately prepared if 2 – 3, and if 0 - 1 the arrangement was defined as poorly prepared for the delivery of wife.
The effect of the health education intervention on spousal knowledge and participation in birth preparedness was tested using analyses of covariance (ANCOVA) and hierarchical linear regression (to control for the demographic variables). Due to the reason that the participants in the study initially were not randomly assigned to the comparison and intervention groups, analysis of covariance (ANCOVA) was used to adjust for any preexisting between group differences not controlled for at the study's onset. ANCOVA, using the pre-test mean scores as a covariate, would help to determine whether the adjusted post-test mean scores between the two sample groupings were significantly different from another (F-value; confidence level of p < 0.05).
Levene’s test was used to test the ANCOVA assumption of homogeneity of variance of the dependent variable. The categorical independent variables (health education and demographic variables) used as predictors of the outcome variables were transformed to dummy variables before conducting the regression analysis. The assumptions of hierarchal linear regression analysis of linearity between independent and outcome variables, normal distribution of outcome variables and multicollinearity between the independent variables were checked and met. The statistical significance level was set at p < 0.05.