Perinatal mHealth Intervention in Guatemala
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02348840 |
Recruitment Status :
Completed
First Posted : January 28, 2015
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Prenatal Care | Device: mHealth | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: mHealth midwives
Midwives will receive access to mHealth technology immediately and use it for 12 months
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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.
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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.
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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. |
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348840
Guatemala | |
Wuqu' Kawoq | |
Santiago Sacatepéquez, Guatemala |
Principal Investigator: | Gari Clifford, PhD | Emory University |
Documents provided by Gari Clifford, Emory University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |
Midwives Pregnant Women |