Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival

2016-09-21 20:23:22 | BioPortfolio


The purpose of this community-based randomized controlled trial is to test whether the mCARE-II intervention package, delivered by the existing Government of Bangladesh community health workforce, will improve neonatal and perinatal survival in a rural setting in northwestern Bangladesh. mCARE-II is a digital health intervention, which incorporates automated workload scheduling, client prioritization and risk stratification, overdue service reminders and demand generation through client side reminder messaging. The intervention package focuses on the pregnancy and early postpartum period.


The aim of this study is to implement and evaluate the mCARE-II intervention package using a randomized controlled trial design. This package, supported by an mHealth application, provides workflow scheduling for guided household registration, census, pregnancy surveillance, and antenatal, postnatal, and essential newborn care visit reminders. Workflow scheduling is sorted and prioritized based on assessment of basic risk. Furthermore, the system integrates client-directed reminder SMS messages and demand-side birth notifications to schedule postnatal services immediately after birth. This will be operated by the Government of Bangladesh (GoB) community health workers, called Family Welfare Assistants (FWAs), in 18 unions of one northern district of Bangladesh who will use the system to support their routine health service delivery functions. Based on lessons learned from phase I implementation under the pilot study, additional features will be added to the intervention package, including a priority sorting algorithm to identify pregnant women and newborns with known risk factors for adverse outcomes to prioritize them for scheduled visits, a birth preparedness module to help pregnant women and their families plan for safe delivery and childbirth, and targeted newborn care counseling during late antenatal encounters. These features will be built on a scalable platform compatible with national data systems and aligned with a new global standard being advocated by WHO - the Open Smart Register Platform or OpenSRP (

Based on randomization to mCARE-II or control arms by FWA catchment area, participants living in each area will receive services from their FWA, either supported by OpenSRP or according to the standard of care procedures currently in place. Performance of the FWAs and the health status of enrolled women and newborns will be monitored and evaluated by a rigorous research layer supported by a cadre of research workers who will verify services received by participants to assess exposure to and interactions with FWAs and OpenSRP. This study combines a robust RCT methodology with principles of implementation science - actual government health workers using OpenSRP to support their routine work while a cadre of highly-trained research workers collects 'gold-standard' denominator data against which to measure performance. This study is an effort to rigorously evaluate the set of mCARE-II interventions on the OpenSRP platform.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


High Perinatal Mortality




JiVitA: Maternal and Child & Nutrition Research Site




Johns Hopkins Bloomberg School of Public Health

Results (where available)

View Results


Published on BioPortfolio: 2016-09-21T20:23:22-0400

Clinical Trials [304 Associated Clinical Trials listed on BioPortfolio]

Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences (OPEN : Organization, Practices Evaluation in Perinatal Network)

This cluster-randomised controlled trial will test the hypothesis that a multifaceted program with psychological intervention in morbidity mortality conferences (MMC) improve care quality ...

Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from...

Cognitive Behavioural Group Therapy for Perinatal Anxiety

Anxiety Disorders (AD) are a serious mental health concern, affecting up to 15% of perinatal women. AD often coexists with depression and result in high distress and an impaired ability fo...

Neurological Consequences of Perinatal Listeriosis Infection

The purpose of the study is to determine whether perinatal listeriosis is associated with long-term neurological consequences, and to evaluate the respective contribution of perinatal seps...

Effect of Exercise on Perinatal Depression

Fifteen percent of women experience depression during pregnancy or postpartum (i.e., perinatal depression). Furthermore, 38% of low income women experience postpartum depression. Given few...

PubMed Articles [19113 Associated PubMed Articles listed on BioPortfolio]

Perinatal Mortality Magnitude, Determinants and Causes in West Gojam: Population-Based Nested Case-Control Study.

In Ethiopia, even if a significant reduction in child mortality is recorded recently, perinatal mortality rate is still very high. This study assessed the magnitude, determinants and causes of perinat...

Perinatal Health Statistics as the Basis for Perinatal Quality Assessment in Croatia.

Context. Perinatal mortality indicators are considered the most important measures of perinatal outcome. The indicators reliability depends on births and deaths reporting and recording. Many publicati...

Down syndrome: perinatal mortality risks with each additional week of expectant management.

To evaluate the gestational age (GA) at which perinatal mortality risk is minimized for fetuses with Down syndrome (DS).

Association Between Isolated Single Umbilical Artery and Perinatal Outcomes: A Meta-Analysis.

BACKGROUND To evaluate the association between the isolated single umbilical artery (iSUA) and perinatal outcomes, including pregnancy outcomes and perinatal complications. MATERIAL AND METHODS We per...

Third trimester perinatal mortality associated with immediate delivery versus expectant management according to birthweight category.

Immediate delivery compared with expectant management in a low risk population stratified by birthweight.

Medical and Biotech [MESH] Definitions

A genetic disorder with autosomal recessive inheritance, characterized by multiple CYSTS in both KIDNEYS and associated LIVER lesions. Serious manifestations are usually present at BIRTH with high PERINATAL MORTALITY.

Deaths occurring from the 28th week of GESTATION to the 7th day after birth.

The branch of medicine dealing with the fetus and infant during the perinatal period. The perinatal period begins with the twenty-eighth week of gestation and ends twenty-eight days after birth. (From Dorland, 27th ed)

An acute, transmissible, infectious disease associated with high MORTALITY and MORBIDITY in young turkeys (poults). It is characterized by DIARRHEA; ANOREXIA; growth depression, and immune dysfunction. The cause is unknown but astroviruses (AVASTROVIRUS) and coronaviruses (CORONAVIRUS, TURKEY) have been isolated from diseased poults and are thought to cause the enteritis and increased susceptibility to bacterial infections.

Clinically severe acute disease of cattle caused by noncytopathic forms of Bovine viral diarrhea virus 2 (DIARRHEA VIRUS 2, BOVINE VIRAL). Outbreaks are characterized by high morbidity and high mortality.

More From BioPortfolio on "Measuring the Impact of a Mobile Health System to Support Healthy Pregnancies and Improve Newborn Survival"

Quick Search

Relevant Topics

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Obstetrics and gynaecology
Fertility Menopause Obstetrics & Gynaecology Osteoporosis Women's Health Obstetrics and gynaecology comprises the care of the pregnant woman, her unborn child and the management of diseases specific to women. Most consultant...

Searches Linking to this Trial