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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD084114-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHealth midwives | Experimental | Midwives will receive access to mHealth technology immediately and use it for 12 months |
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| 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. |
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| Pregnant Women | Active Comparator | Pregnant women may or may not receive mHealth technology, based on the collaborating midwife they are assigned. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for Midwives:
Exclusion Criteria for Midwives:
Inclusion Criteria for Pregnant Women:
Exclusion criteria for pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Gari Clifford, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuqu' Kawoq | Santiago Sacatepéquez | Guatemala |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29973229 | Result | 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. | |
| 31115904 | Derived | 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. |
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Data will be de-identified and shared through PhysioNet.org. Raw 1-D ultrasound data plus associated demographics will be available.
Data is estimated to become available in 2022 after compilation and analysis is complete.
Data will be publicly available via PhysioNet.org with no restrictions on analyses.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | TBA - Early Access Arm | Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months |
| FG001 | 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 |
| FG002 | Pregnant Women - Early Access Arm | Pregnant women under the care of traditional birth attendants in the early access arm |
| FG003 | Pregnant Women - Later Access Arm | Pregnant women under the care of traditional birth attendants in the later access arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analysis population includes all TBAs and pregnant women for whom demographic data was collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | TBA - Early Access Arm | Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months |
| BG001 | 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 |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All TBAs are included in this analysis. | Posted | Median | Inter-Quartile Range | Referrals per 100 births | Month 7, Month 12 |
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Protocol-related adverse events for pregnant participants were collected during the 12 month intervention period.
Only protocol-related serious and non-serious adverse events for pregnant participants were collected. Adverse events were not collected from the traditional birth attendants as adverse events related to the study intervention were not expected to impact these participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TBA - Early Access Arm | Traditional birth attendants receiving access to mHealth technology immediately and using it for 12 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gari D. Clifford, DPhil | Emory University | 404-727-0229 | gari.clifford@emory.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2014 | Jul 12, 2019 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 5, 2018 | Aug 7, 2019 | ICF_002.pdf |
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| Month 7, Month 12 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | All pregnant participants are included in this analysis. | Posted | Number | deaths | Month 12 |
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| 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. | 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. | Posted | Number | Referrals to hospital | Month 7, Month 12 | Referrals made during the study period | Referrals made during the study period |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | TBA - Later Access Arm | Traditional birth attendants without access to mHealth technology for the first six months, and then using the technology for the remaining six months | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 2 | 425 | 0 | 425 | 0 | 425 |
| EG003 | 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 | 1 | 374 | 0 | 374 | 0 | 374 |
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| Second study period |
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