A Community Trial to Measure the Effect of Individual Prenatal Education With Mobile Phone Consultations Offered to Pregnant Women in Masindi and Kiryandongo, Western Uganda

Study design This was a pragmatic community randomized trial. A mixed method of data collection was used.

Randomization Health centres that offered antenatal and delivery care were eligible for randomization. Sixteen health centres, excluding the main hospitals, were identified and randomly allocated to the intervention (eight health centres) and control (eight health centres) arms of the study. To allow equitable representations from each district, proportionate numbers of health centres were selected from Masindi (ten health centres) and Kiryandongo (six health centres). In the intervention health centres five villages each were randomly selected to participate in the study. In each village one member of the VHT was selected to participate in the study. VHTs were selected on the basis of their active participation in other related projects. Active VHTs were considered appropriate since this was largely a voluntary intervention with minimal financial and material benefits. In both arms pregnant women who were making their first antenatal consultation were eligible to participate in the study regardless of their gravidity status. Those women who presented with twenty eight weeks of amenorrhea or less on palpation qualified for inclusion. The investigators did not develop any criteria for exclusion from the study. Blinding was not necessary since randomization was done at the level of health centres.

Pre-intervention data assessments from routine health management information systems showed that 80% of pregnant women in this region made first antenatal consultations from twenty eight weeks of amenorrhea and more. Also, on average, each village is expected to have 25 deliveries in a year (considering a population of 500 inhabitants). Therefore, for each health centre where five villages were selected, the investigators expected 125 deliveries per year. But, only 80% of them make first antenatal visit within twenty eight weeks (our inclusion criteria) the investigators expected to recruit 100 women per health centre over the entire study period bringing the total to 800 women per arm.

Intervention The investigators will use a pragmatic approach to the intervention whereby the investigators considered implementation of the intervention in the normal environment without any modifications of the context, no restriction in selection of study participants as long as they qualified and health staff were allowed to implement the intervention through the normal care delivery of the health centre without creation of parallel structures [23-25]. However, the investigators developed simple standard operating procedures for all health workers and VHTs to ensure a standardized approach and to help them not to inadvertently forget certain aspects of the intervention.

Selected VHTs were trained based on the manual for educational information offered to pregnant women published in the 'mother's passport' and other widely available training materials in Uganda. The mother's passport is a booklet locally designed with pictorials for use at the health facility in the Ugandan context. It elaborates step by step what information is required of a pregnant woman during pregnancy and the care practices for newborn care. Trainers adopted an interactive and participative approach with the aim of developing group facilitation skills among the VHTs. The training lasted for five consecutive days. To maintain enthusiasm among trainees each training-day lasted between 9.00 am to 2.00 pm. The first day of training was dedicated to the problem of newborn care and why it is important to invest time and efforts in improving the health of newborn babies. On the second day, VHTs were taken through the mother's passport using pictorials and how to conduct an educational session with the families. On the third and fourth days role-plays were conducted and pre-test in a real life situation using a field-based practicum was conducted. On the fifth day, VHTs were initiated into the actual study protocol using a simplified standard operating procedure. This training was done together with the health workers of the selected health centres. The practicum sessions were critiqued by fellow VHTs and improvements suggested.