Perinatal mHealth Intervention in Guatemala

• ClinicalTrials.gov Identifier: NCT02348840
• Recruitment Status: Completed
• First Posted: January 28, 2015
• Results First Posted: August 9, 2019
• Last Update Posted: August 9, 2019
• Sponsor: Emory University
• 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

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 843 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
• Actual Primary Completion Date: February 28, 2018
• Actual Study Completion Date: February 28, 2018

Arms and Interventions

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

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• 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

Locations

Guatemala

Wuqu' Kawoq

Santiago Sacatepéquez, Guatemala

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

  Study Documents (Full-Text)

Documents provided by Gari Clifford, Emory University:

Study Protocol  [PDF] December 19, 2014

Informed Consent Form  [PDF] December 5, 2018

No Statistical Analysis Plan (SAP) exists for this study.

More Information

Publications of Results:

Martinez B, Ixen EC, Hall-Clifford R, Juarez M, Miller AC, Francis A, Valderrama CE, Stroux L, Clifford GD, Rohloff P. mHealth intervention to improve the continuum of maternal and perinatal care in rural Guatemala: a pragmatic, randomized controlled feasibility trial. Reprod Health. 2018 Jul 4;15(1):120. doi: 10.1186/s12978-018-0554-z.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Juarez M, Martinez B, Hall-Clifford R, Clifford G, Rohloff P. Investigating barriers and facilitators to facility-level births in rural Guatemala. Int J Gynaecol Obstet. 2019 Sep;146(3):386-387. doi: 10.1002/ijgo.12865. Epub 2019 Jun 10.

• Responsible Party: Gari Clifford, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02348840
• Other Study ID Numbers: IRB00076231; R21HD084114-02 ( U.S. NIH Grant/Contract )
• First Posted: January 28, 2015
• Results First Posted: August 9, 2019
• Last Update Posted: August 9, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data will be de-identified and shared through PhysioNet.org. Raw 1-D ultrasound data plus associated demographics will be available.
• Supporting Materials: Study Protocol; 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 PhysioNet.org with no restrictions on analyses.

• 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