Perinatal mHealth Intervention in Guatemala

NCT02348840 | Completed Results

• 2 other identifiers: IRB00076231R21HD084114-02
• Study Type: interventional
• Target: 843
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Prenatal Care

Keywords

Midwives; Pregnant Women

Outcome Measures

Primary Outcomes (2)

• 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.

  Month 7, Month 12

• 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.

  Month 12

Secondary Outcomes (1)

• Successful Referrals

  Month 7, Month 12

Study Arms (3)

mHealth midwives

EXPERIMENTAL

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

Device: mHealth

mHealth midwives - control

ACTIVE COMPARATOR

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

Pregnant Women

ACTIVE COMPARATOR

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

Device: mHealth

Interventions

mHealth 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; mHealth midwives; mHealth midwives - control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Wuqu' Kawoq

Santiago Sacatepéquez, Guatemala

Location

Related Publications (2)

• 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.

  PMID: 29973229 RESULT

• 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.

  PMID: 31115904 DERIVED

Results Point of Contact

• Title: Gari D. Clifford, DPhil
• Organization: Emory University

gari.clifford@emory.edu

404-727-0229

Study Officials

• Gari Clifford, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: January 28, 2015
• Study Start: January 1, 2015
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: August 9, 2019
• Results First Posted: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

GU (1)