Perinatal mHealth Intervention in Guatemala
Condition: Pregnancy; Prenatal Care
Study type: Interventional

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.
    

Intervention name(s): mHealth
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Midwives; Pregnant Women