NCT02348840

Perinatal mHealth Intervention in Guatemala

Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 843 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to explore ways to improve maternal and child outcomes in the ethnic Maya speaking the Kaqchikel language population, which experiences wide disparities in health care access and outcomes when compared to other inhabitants of Guatemala who are not ethnically Maya and live in other parts of the country.

Detailed description

While advances in medical care have reduced mortality rates across the globe, the same cannot be said for perinatal mortality. This is particularly true of Low and Middle Income Countries (LMICs), which contribute by far the largest proportion of the estimated 5.4 million perinatal deaths annually. Key reasons for this include lack of systematic screening, lack of early health advice-seeking, lack of training for the healthcare workers involved in the healthcare delivery chain and a lack of robust referral. To address these issues, the investigators will introduce and evaluate a scalable mobile health (mHealth) referral system in Guatemala, one of the poorest countries in Latin America with one of the highest perinatal mortality rates. The system combines several key innovations which have been developed over the last 10 years. First, the investigators will introduce a low cost (under $30) ultrasound screening tool, with a blood pressure cuff and pulse oximeter, from which data is fed directly to a smartphone to produce an on-the-spot assessment of the health of the fetus and mother, using a step-by-step pictorial guide (also on the phone). Second, the investigators will implement a mobile phone-mediated medical record and referral system that allows users of both smartphones and basic mobile phones to upload data into a standardized medical record system already in operation in Guatemala. The data will allow healthcare workers to identify or enroll patients, review their histories, and schedule future screenings or follow-up visits, as well as equip the healthcare providers with the necessary information to assess needs, resource allocation and efficacy of treatment or personnel. Thirdly, the investigators will introduce a training protocol for lay midwives to provide routine screening with the system for risk factors such as high blood pressure, fetal growth restriction and fetal distress, and to promote postnatal care coordination. Importantly, this shared system will facilitate communication between the obstetrical care team and the postnatal child care team, which currently represents one of the most pressing care coordination challenges in rural Guatemala. By bringing together engineers, physicians, public health workers, anthropologists, and local nongovernmental organizations to co-design the system around the needs of the existing healthcare infrastructure and the local population, the investigators will create an intuitive system which relieves the burden of data collection, improves diagnostic capabilities, and assists with rapid and accurate referral. The system will also facilitate inter-facility research by introducing a standard medical record protocol.

Conditions

• Pregnancy
• Prenatal Care

Interventions

Type	Name	Description
DEVICE	mHealth	A cell phone that can capture data measurements from devices on blood pressure, oxygen level, the heart rate of pregnant women, and the heart rate of the baby.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2015-01-28
• Last updated: 2019-08-09
• Results posted: 2019-08-09

Locations

1 site across 1 country: Guatemala