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Perinatal mHealth Intervention in Guatemala

Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02348840
Enrollment
843
Registered
2015-01-28
Start date
2015-01-31
Completion date
2018-02-28
Last updated
2019-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Prenatal Care

Keywords

Midwives, Pregnant Women

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.

Interventions

DEVICEmHealth

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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Referral Rates to Local HospitalsMonth 7, Month 12TBAs 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 DeathsMonth 12The 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

MeasureTime frameDescription
Successful ReferralsMonth 7, Month 12Referrals 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.

Countries

Guatemala

Participant flow

Recruitment details

Traditional birth attendants (TBAs) were recruited from the municipality of Tecpán Chimaltenango, in rural Guatemala. Enrollment of the TBAs began in January 2015 and eligible pregnant participants were recruited from April 2016 to March 2017. All study follow up ended by February 28, 2018.

Pre-assignment details

There were 64 TBAs in the study area meeting eligibility criteria who were invited to attend an informational session. Of the eligible TBAs, 49 attended the session and 44 of those individuals agreed to participate in the study.

Participants by arm

ArmCount
TBA - Early Access Arm
Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months
23
TBA - Later Access Arm
Traditional birth attendants (TBAs) without access to mHealth technology for the first half of the study who then used mHealth for the remaining time of the 12 month study period
21
Pregnant Women - Early Access Arm
Pregnant women under the care of traditional birth attendants in the early access arm, who completed their pregnancy during the study period
335
Pregnant Women - Later Access Arm
Pregnant women under the care of traditional birth attendants in the later access arm, who completed their pregnancy during the study period
327
Total706

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyWithdrawal by Subject2100

Baseline characteristics

CharacteristicTBA - Early Access ArmTBA - Later Access ArmPregnant Women - Early Access ArmPregnant Women - Later Access ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
23 Participants21 Participants335 Participants327 Participants706 Participants
Race/Ethnicity, Customized
Indigenous Mayan
23 Participants21 Participants335 Participants327 Participants706 Participants
Region of Enrollment
Guatemala
23 Participants21 Participants335 Participants327 Participants706 Participants
Sex: Female, Male
Female
23 Participants21 Participants335 Participants327 Participants706 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 02 / 4251 / 374
other
Total, other adverse events
0 / 00 / 00 / 4250 / 374
serious
Total, serious adverse events
0 / 00 / 00 / 4250 / 374

Outcome results

Primary

Number of Neonatal Deaths

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.

Time frame: Month 12

Population: All pregnant participants are included in this analysis.

ArmMeasureValue (NUMBER)
TBA - Early Access ArmNumber of Neonatal Deaths7 deaths
TBA - Later Access ArmNumber of Neonatal Deaths3 deaths
Primary

Referral Rates to Local Hospitals

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.

Time frame: Month 7, Month 12

Population: All TBAs are included in this analysis.

ArmMeasureGroupValue (MEDIAN)
TBA - Early Access ArmReferral Rates to Local HospitalsMonth 733 Referrals per 100 births
TBA - Early Access ArmReferral Rates to Local HospitalsMonth 1231 Referrals per 100 births
TBA - Later Access ArmReferral Rates to Local HospitalsMonth 720 Referrals per 100 births
TBA - Later Access ArmReferral Rates to Local HospitalsMonth 1234 Referrals per 100 births
Secondary

Successful Referrals

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.

Time frame: Month 7, Month 12

Population: There were a different number of referrals made during each study period; the overall number analyzed represents the maximum count of referrals in a study period for that study arm.

ArmMeasureGroupValue (NUMBER)
TBA - Early Access ArmSuccessful ReferralsFirst study period69 Referrals to hospital
TBA - Early Access ArmSuccessful ReferralsSecond study period48 Referrals to hospital
TBA - Later Access ArmSuccessful ReferralsFirst study period44 Referrals to hospital
TBA - Later Access ArmSuccessful ReferralsSecond study period47 Referrals to hospital

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026