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Perinatal mHealth Intervention in Guatemala

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ClinicalTrials.gov Identifier: NCT02348840
Recruitment Status : Recruiting
First Posted : January 28, 2015
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Gari Clifford, Emory University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Prenatal Care Device: mHealth Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala
Actual Study Start Date : January 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: mHealth midwives
Midwives will receive access to mHealth technology immediately and use it for 12 months
 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.
Active Comparator: mHealth midwives - control
Midwives will not have access to mHealth technology for the first six months, and then will receive the technology for the remaining six months.
 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.
Active Comparator: Pregnant Women
Pregnant women may or may not receive mHealth technology, based on the collaborating midwife they are assigned.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in referral rates to local hospitals [ Time Frame: Baseline, 12 months ]
    Percentage of pregnant women referred to hospitals for further treatment/evaluation

  2. Perinatal mortality [ Time Frame: Participants will be followed from delivery until 7 days postpartum ]
    Stillbirth and early neonatal death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Midwives:

  • Wuqu' Kawoq's catchment area
  • Bilingual speakers of Spanish and Kaqchikel Maya
  • Willing to give consent and be trained on the mHealth technology
  • Must be under the age of 65
  • Must be 18 years-old or older

Exclusion Criteria for Midwives:

  • Outside Wuqu' Kawoq's catchment area
  • Not a bilingual speaker of Spanish and Kaqchikel Maya
  • Over the age of 65
  • Under the age of 18
  • Unable to give consent and be trained on the mHealth technology

Inclusion Criteria for Pregnant Women:

  • Must be 18 years-old or older
  • Must be pregnant
  • Must have a midwife that has been recruited for the study
  • Bilingual speakers of Spanish and Kaqchikel Maya
  • Willing to give consent

Exclusion criteria for pregnant women

  • Under 18 years of age
  • Not pregnant
  • Does not have a midwife in the study
  • Is not bilingual in Spanish and Kaqchikel Maya
  • Unable to consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348840


Contacts
Contact: Gari Clifford, PhD 404.712.0163 gari.clifford@emory.edu

Locations
Guatemala
Wuqu' Kawoq Recruiting
Santiago Sacatepéquez, Guatemala
Contact: Peter Rohloff, MD    +50250005833    peter@wuqukawoq.org   
Principal Investigator: Gari Clifford, PhD         
Sponsors and Collaborators
Emory University
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Gari Clifford, PhD Emory University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gari Clifford, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02348840     History of Changes
Other Study ID Numbers: IRB00076231
R21HD084114-02 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be de-identified and shared through PhysioNet.org

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gari Clifford, Emory University:
Midwives
Pregnant Women