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Perinatal mHealth Intervention in Guatemala

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02348840
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
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

Tracking Information
First Submitted Date  ICMJE January 23, 2015
First Posted Date  ICMJE January 28, 2015
Results First Submitted Date  ICMJE June 4, 2019
Results First Posted Date  ICMJE August 9, 2019
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Referral Rates to Local Hospitals [ Time Frame: Month 7, Month 12 ]
    TBAs refer pregnant women to local hospitals for further evaluation or treatment when a pregnancy complications are detected. The median adjusted monthly emergency referral rates (referrals/births) per 100 births for each time period are presented here.
  • Number of Neonatal Deaths [ Time Frame: Month 12 ]
    The number of neonatal deaths during the entire study period are presented. Baseline complication rates were unknown for this study population and the study was not powered to detect a difference in the rate of any complication (including neonatal deaths), thus only the total deaths during the entire 12 month period are included.
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
  • Change in referral rates to local hospitals [ Time Frame: Baseline, 12 months ]
    Percentage of pregnant women referred to hospitals for further treatment/evaluation
  • Perinatal mortality [ Time Frame: Participants will be followed from delivery until 7 days postpartum ]
    Stillbirth and early neonatal death
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
Successful Referrals [ Time Frame: Month 7, Month 12 ]
Referrals to hospitals for further evaluation of possible pregnancy complications were considered to be successful if the pregnant participant went to the hospital after being referred by her TBA. Non-successful referrals were due to the pregnant participant's refusal to go to the hospital (due to lack of permission from a family member, fear, or not recognizing the complication as an emergency) or due to logistical difficulties.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Perinatal mHealth Intervention in Guatemala
Official Title  ICMJE Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Pregnancy
  • Prenatal Care
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: mHealth midwives
    Midwives will receive access to mHealth technology immediately and use it for 12 months
    Intervention: Device: mHealth
  • 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.
    Intervention: Device: mHealth
  • Active Comparator: Pregnant Women
    Pregnant women may or may not receive mHealth technology, based on the collaborating midwife they are assigned.
    Intervention: Device: mHealth
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2015)
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guatemala
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02348840
Other Study ID Numbers  ICMJE IRB00076231
R21HD084114-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be de-identified and shared through Raw 1-D ultrasound data plus associated demographics will be available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data is estimated to become available in 2022 after compilation and analysis is complete.
Access Criteria: Data will be publicly available via with no restrictions on analyses.
Responsible Party Gari Clifford, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Gari Clifford, PhD Emory University
PRS Account Emory University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP