Globally, 2.5 million neonates die and 2 million more are stillborn each year; the vast majority occur where access to life-saving care is limited. High quality, feasible interventions are needed to reach, educate and empower pregnant women and new mothers to improve care-seeking behaviors. Mobile WACh (Mobile solutions for Women’s and Children’s health) NEO is a human-computer hybrid mobile health (mHealth) system that allows for two-way short message service (SMS) communication between women and healthcare workers during the peripartum period. We performed a secondary prospective cohort analysis of data from the Mobile WACh NEO pilot study to determine maternal characteristics associated with neonatal death and stillbirth and examine participant messaging associated with these events. Pregnant women were enrolled at two Kenyan public health clinics between 28–36 weeks gestation. They received personalized, educational, action-oriented SMS messages during pregnancy and through 14 weeks postpartum. Participants could message the study at any time and study nurses responded. Standardized questionnaires assessed participant characteristics at baseline and 14 weeks postpartum. Outcomes were ascertained at study visits or by SMS report. Among 798 pregnant women enrolled, median age was 24 years [IQR 21, 29], 37% were primiparous and 92% used SMS as a primary mode of communication. Seventeen neonatal deaths and 13 stillbirths occurred. Older maternal age was associated with increased risk of stillbirth [aRR 1.12 (CI 1.02–1.24), p <0.05]. We found no significant predictors of neonatal death. Participant messaging to study nurse about concerns in the week preceding death was less common prior to infant death after discharge home from facility birth (9%) than prior to stillbirth (23%). We found limited predictors of neonatal death and stillbirth, suggesting identifying women prenatally for targeted support may not be a feasible strategy. Scarce messaging from mothers whose neonates died may reflect difficulties identifying illness or rapid deterioration and needs to be better understood to design and test interventions for this high-risk period. Messaging prior to stillbirth, while at similar levels as other periods, does not appear to have an impact as most women do not experience identifiable signs or symptoms prior to the event.

IntroductionGlobally, approximately half of the estimated 6.3 million under-5 deaths occur in the neonatal period (within the first 28 days of life). Kenya ranks among countries with the highest number of neonatal deaths, at 20 per 1000 live births. Improved identification and management of neonates with potentially life-threatening illness is critical to meet the WHO’s target of ≤12 neonatal deaths per 1000 live births by 2035. We developed an interactive (two-way) short messaging service (SMS) communication intervention, Mobile Solutions for Neonatal Health (Mobile women’s and children’s health (WACh) NEO), focused on the perinatal period. Mobile WACh NEO sends automated tailored SMS messages to mothers during pregnancy and up to 6 weeks post partum. Messages employ the Information-Motivation-Behaviour Skills framework to promote (1) maternal implementation of essential newborn care (ENC, including early, exclusive breast feeding, cord care and thermal care), (2) maternal identification of neonatal danger signs and care-seeking, and (3) maternal social support and self-efficacy. Participants can also send SMS to the study nurse, enabling on-demand remote support.Methods and analysisWe describe a two-arm unblinded randomised controlled trial of the Mobile WACh NEO intervention. We will enrol 5000 pregnant women in the third trimester of pregnancy at 4 facilities in Kenya and randomise them 1:1 to receive interactive SMS or no SMS (control), and conduct follow-up visits at 2 and 6 weeks post partum. Neonatal mortality will be compared between arms as the primary outcome. Secondary outcomes include care-seeking, practice of ENC and psychosocial health. Exploratory analysis will investigate associations between maternal mental health, practice of ENC, care-seeking and SMS engagement.Ethics and disseminationThis study received ethical approval from the University of Washington (STUDY00006395), Women and Infants Hospital (1755292-1) and Kenyatta National Hospital/University of Nairobi (P310/04/2019). All participants will provide written informed consent. Findings will be published in peer-reviewed journals and international conferences.Trial registration numberNCT04598165

Background Perinatal depression is broadly defined as depressive symptoms during pregnancy or within the 12 months following delivery, affecting approximately 20–25% of pregnant and postpartum women in low- and middle-income countries. The wide accessibility of mobile phones allows mobile health (mHealth) interventions to be considered a solution to identify perinatal depression and provide appropriate referrals for treatment. This study, nested in a larger SMS communication project, examined the prevalence and correlates of perinatal depression, determined the association between antenatal depression and infant morbidity and mortality, and compared SMS communication patterns between women with and without perinatal depression. Methods This was a prospective longitudinal cohort study of pregnant women seeking antenatal services at two public sector health clinics in Kenya. SMS messages were sent to participants with educational content related to their pregnancy and infant health and two-way SMS communication occurred with a nurse. Sociodemographic and obstetric characteristics, SMS messaging behaviors, infant health status, and depressive symptoms were assessed by a standardized questionnaire administered at enrollment (30–36 weeks gestation) and follow-up (14 weeks postpartum). Generalized estimating equation (GEE) with Poisson link was used to evaluate correlates of perinatal depressive symptoms, infant outcomes, and frequency of SMS messaging. Results Of the 572 women with complete follow-up information, 188 (32.9%) screened positive for elevated depressive symptoms (≥10 by EPDS scale) at some time point during pregnancy or postpartum. The strongest predictors of any depressive symptoms included interpersonal abuse during pregnancy, fewer years of schooling, and maternal unemployment. Antenatal depressive symptoms were associated with an increased risk of infant illness or hospitalization (RR = 1.12, 95% CI: 1.11, 1.13). Women with antenatal or persistent perinatal depressive symptoms sent fewer SMS messages during the study period than their counterparts without depression. Conclusions Prevalence of elevated perinatal depressive symptoms was high in this cohort of Kenyan women. Our findings highlight the importance of screening perinatal women for experiences of symptoms of depression as well as abuse. Differences in messaging frequency between women with vs. without depressive symptoms presents an opportunity to provide more tailored support for those perinatal depression.

Background: Globally, approximately half of the estimated 6.3 million under-5 deaths occur in the neonatal period (within the first 28 days of life) and 75% of neonatal deaths occur in the first week of life. Kenya ranks among countries with the highest number of neonatal deaths, with a neonatal mortality rate of 20 per 1000 live births. Novel strategies are needed to meet the WHO’s Every Newborn Action Plan target of 10 or fewer neonatal deaths per 1000 live births by 2035. Improved identification and management of neonates with potentially life-threatening illness is critical. We developed an interactive (two-way) human-computer hybrid SMS intervention, Mobile Solutions for Neonatal Health (Mobile WACh NEO), focused on the perinatal period when risk to mothers and infants is highest. Mobile WACh NEO sends automated tailored and personalized SMS messages to mothers during pregnancy and up to 6 weeks postpartum. Messages employ the Information-Motivation-Behavior Skills (IMB) behavioral theory framework to promote 1) maternal implementation of essential newborn care (ENC, which includes early breastfeeding, exclusive breastfeeding, cord care and thermal care), 2) maternal identification of neonatal danger signs and care-seeking, and 3) maternal social support and self-efficacy. Participants can also send SMS to the study nurse, enabling on-demand remote support.Methods: We describe a two-arm unblinded randomized controlled trial (RCT) of the Mobile WACh NEO SMS intervention. The RCT will enroll 5000 third trimester pregnant women in 4 facilities in Kenya and randomize them 1:1 to receive interactive SMS communication or no SMS (control), and conduct follow-up study visits at 2 and 6 weeks postpartum. Neonatal mortality will be compared between arms as the primary outcome. Secondary outcomes include care-seeking, practice of ENC, and psychosocial health. Exploratory analysis will investigate associations between maternal mental health, practice of ENC, care-seeking and SMS engagement.Discussion: This study will contribute evidence on the impact of two-way SMS in a low-income setting on neonatal outcomes, using a rigorous evaluation design. This study will build evidence to fill a gap in understanding drivers of neonatal outcomes and the potential impact of SMS interventions.Trial registrationTrial registration: clinicaltrials.gov, NCT04598165. Registered October 22, 2020 – retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT04598165.

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