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.