Methods
The community-based cluster RCT (trial registration: UMIN000025628) was conducted in two upazilas (administrative regions in Bangladesh), Dhamrai in Dhaka District, Dhaka Division and Lohagora in Narail District, Khulna Division from February 2017 to August 2018. The population of each upazila ranged from 200,000 to 500,000 in Bangladesh. The study period covered the duration from the start point at which the pregnant women were identified and recruited to the end point (end of the fourth week after giving birth). The cluster, the unions in each upazila, rather than the individual, was subjected to the randomized sampling. The target population, pregnant women aged 15 to 49 years living in the selected settings and expected to give birth between 1 August 2017 and 31 July 2018, and their families, were identified by community health workers (CHWs) and enrolled in the study. We also included healthcare providers at different levels: CHWs (the key player at the primary level), skilled birth attendants (SBAs) and health professionals working at upazila hospitals to cooperate our study. We also included gynecologist in each upazila as required. The selected unions were randomly allocated to either 1) the intervention that combined mobile phone communication with MCH, 2) the intervention using MCH alone or 3) the control, where no intervention was implemented. A total of 3,002 participants were finally recruited, including 998 for the intervention 1, 1,001 for the intervention 2 and 1,003 for the control. Table 1 summarizes the participants in the study settings. Details of study design and sampling issues were described in our published protocol 26.
The interventions were designed to promote two-way communications between pregnant women/their families and CHWs by an empowering approach. Contents of MCH encompassed the general profile of pregnant mother, menstrual history and history of previous pregnancy (if any), records of health education and consulting, records of conditions/health status, healthcare utilization and clinical results during pregnancy, delivery and postnatal/neonatal period, as well as information on common complications and signs of danger, on health seeking for mothers and babies, and on daily care and nutrition. MCH was distributed to each participant at the point of recruitment. Every two months the enrolled pregnant women and their families and CHWs were organized for community meetings, where health education, consulting/advice and anthropometric measurements were provided to accompany the discussions on seeking health services for mothers and babies and the application of MCH. In Intervention 1, besides MCH and community meetings, user-friendly mobile messages were developed and sent according to the gestational age (GA), including reminders of antenatal and postnatal care visits and facility-based delivery, list of locations of skilled birth attendants and hospitals, GA-specific health issues, daily care and nutrition during pregnancy, intake of iron tablet and folic acid, support from husband and families during pregnancy and lactating period, signs of danger, signs of labor, and postnatal/neonatal care. Audio messages and phone call were also used for follow-up and consulting/advice, as necessary. For those participants in households with no mobile phones, trained staffs made regular visits to their home according to their GA to provide equivalent information.
The expected outcomes were neonatal death, fetal death (stillbirth/miscarriage), preterm birth, low birthweight, maternal pregnancy complications and referral, antenatal care visits for at least one time (ANC1), antenatal care visits for at least four times (ANC4), antenatal care visits for at least six times (ANC6), facility-based delivery (FBD), mode of delivery, utilization of postnatal/neonatal care (PNC), and experience of health education. The definition of neonatal deaths followed the standard employed by WHO, that is, death within the first 28 days of life. By referring Bangladesh Demographic and Health Survey (BDHS) 2014, neonatal deaths and fetal deaths were determined from the complete birth history from mothers and recorded by our trained staffs 28. The continuum of care (COC) for mothers and babies in the study referred to healthcare services during pregnancy, at birth and after birth and the variable was created by combining that of antenatal care, facility-based delivery and postnatal care. Related data were collected by the questionnaire during the study period. At the study settings, the trained staffs tracked the participants during the study period to catch up the maternal and neonatal outcomes promptly and effectively.
For data analysis, univariate analysis was first performed to explore the characteristics of variables. In the comparison of each variable, a stratification by randomization groups was implemented to examine the equality of covariates of the two groups at baseline. Then, multivariate generalized estimating equation (GEE) analyses were implemented, considering a potential correlation in the expected outcomes within unions. Risk ratios (RR) for the targeted outcomes were assessed and 95% confidence interval (CI) were calculated. Data analysis was performed using Stata 15.0.
The study was approved by the Bangladesh Medical Research Council (BMRC), Bangladesh and National Center for Child Health and Development (NCCHD), Japan. Signed consent was taken from all participants.