Perinatal mHealth Intervention in Guatemala

NCT ID: NCT02348840

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 843 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-02-28

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.

Conditions

Pregnancy; Prenatal Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

mHealth midwives

Midwives will receive access to mHealth technology immediately and use it for 12 months

Group Type: EXPERIMENTAL

mHealth

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

mHealth

Intervention Type: DEVICE

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.

Pregnant Women

Pregnant women may or may not receive mHealth technology, based on the collaborating midwife they are assigned.

Group Type: ACTIVE_COMPARATOR

mHealth

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Gari Clifford

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gari Clifford, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Wuqu' Kawoq

Santiago Sacatepéquez, , Guatemala

Countries

Guatemala

References

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.

Reference Type: RESULT

PMID: 29973229 (View on PubMed)

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. No abstract available.

Reference Type: DERIVED

PMID: 31115904 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21HD084114-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00076231

Identifier Type: -

Identifier Source: org_study_id