Pregnancy Clinical Trial
Official title:
Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala
Verified date | August 2019 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 843 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Guatemala | Wuqu' Kawoq | Santiago Sacatepéquez |
Lead Sponsor | Collaborator |
---|---|
Emory University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) |
Guatemala,
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 feas — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Month 7, Month 12 | |
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. | Month 12 | |
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. | Month 7, Month 12 |
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