PregnancyNCT02348840
Perinatal mHealth Intervention in Guatemala
A study testing mHealth in people with Pregnancy and Prenatal Care, run by Emory University at 1 site in Guatemala.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Prenatal Care
- What is being tested?
- mHealth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 843 participants
- Where
- 1 siteGuatemala
- Study dates
- Jan 2015to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Must be 18 years-old or older
Show all 10Show fewer
- 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
Who cannot join
- 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
- Under 18 years of age
Show all 10Show fewer
- Not pregnant
- Does not have a midwife in the study
- Is not bilingual in Spanish and Kaqchikel Maya
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala
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.
Read the 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.
- Conditions
- Pregnancy, Prenatal Care
- Being tested
- mHealth
- Keywords
- Midwives, Pregnant Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth midwives | Experimental | Midwives will receive access to mHealth technology immediately and use it for 12 months Receives: 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. Receives: Device: mHealth |
| Pregnant Women | Active comparator | Pregnant women may or may not receive mHealth technology, based on the collaborating midwife they are assigned. Receives: Device: mHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 12
Secondary outcomes (1)
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.
Measured: Month 7, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Gari Clifford, Emory University
- Investigators
- Gari Clifford, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348840
- Sponsor's protocol ID
- IRB00076231
- Other IDs
- R21HD084114-02
- Status last verified
- Aug 2019
- First submitted
- 23 Jan 2015
- Last updated
- 9 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be de-identified and shared through PhysioNet.org. Raw 1-D ultrasound data plus associated demographics will be available.
Publications
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.
PubMed 29973229Juarez 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.
PubMed 31115904
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala
- ClinicalTrials.gov ID
- NCT02348840
- Acronym / sponsor ID
- IRB00076231
- Conditions
- Pregnancy, Prenatal Care
- Keywords
- Midwives, Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 9 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mHealth midwives | Experimental | Device: mHealthMidwives will receive access to mHealth technology immediately and use it for 12 months |
| mHealth midwives - control | Active comparator | Device: mHealthMidwives will not have access to mHealth technology for the first six months, and then will receive the technology for the remaining six months. |
| Pregnant Women | Active comparator | Device: mHealthPregnant women may or may not receive mHealth technology, based on the collaborating midwife they are assigned. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealthA 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. | Device | Pregnant Women, mHealth midwives, mHealth midwives - control |
Primary outcome
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.
1 secondary outcome
Successful Referrals
Time frame: Month 7, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29973229Martinez 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.
- Derived from this study: PubMed 31115904Juarez 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.
- Individual participant dataSharing planned: Yes. Data will be de-identified and shared through PhysioNet.org. Raw 1-D ultrasound data plus associated demographics will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gari Clifford, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth in people with Pregnancy and Prenatal Care, run by Emory University at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referral Rates to Local Hospitals (time frame: Month 7, Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02348840, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.