Mobile Health Intervention to Improve Perinatal Continuum of Care in Guatemala
Phase: NA
Conditions: Pregnancy, Prenatal Care
Sponsor: Emory University

Mobile Health Intervention to Improve Perinatal Continuum of Care in 
Guatemala 
 
Protocol version date December 19, 2014 
 
NCT02348840 
 
 

Scientific protocol 
 
Human Subjects Involvement, Characteristics, and Design.  
 
The study will enroll participating lay midwives from the department of Chimaltenango in 
central Guatemala. We anticipate enrolling 50 midwives in the project. There will be no 
restrictions in terms of age of the enrolled participants. Participants will be required to 
have basic Spanish language literacy in order to enroll. Some more elderly midwives will 
lack the required literacy and therefore will not be eligible to enroll. However, since the 
project involves use of a Spanish language interface on a cellular phone, this minimum 
requirement is essential to program success. Additionally, in our experience, most elderly, 
illiterate midwives in the communities where the project will be conducted are 
semiretired, and most practicing midwives are literate. Therefore, we do not anticipate 
that a significant portion of the eligible pool of midwives will be excluded from 
participation based on the literacy requirement. Recruitment identification will be by 
word of mouth through the local site partner’s well-established contacts with midwives in 
the community.  
 
In addition to enrollment of midwives, who will be the primary subjects of the project, the 
project will also collect demographic and health data on consenting pregnant patients of 
each practicing midwife, as well as neonates that are born to consenting pregnant patients 
during the project. No data will be collected on other patient populations other than these 
pregnant women and their neonates. Since this is a study of the use of mHealth technology 
to improve pregnancy and neonatal outcomes, it is important to collect data both on the 
pregnant women during the pregnancy, as well as data on the neonate in the first month 
of life.  
 
Of the 50 recruited midwives, 25 will be randomly assigned to receive access to the 
mHealth technology immediately, whereas the remaining 25 will receive the technology 
after 6 months. Randomization of the midwives will be performed by entering their IDs 
into a list and running a simple program to generate an equal number of 1’s and zeros, 
uniquely assigned to each midwife ID. For the second half of the 12 month implementation 
phase, all 50 midwives will have access to the technology. This randomized “stepped 
wedge” design is critical to the evaluation of the project, since baseline data (for example, 
on referral rates to local hospitals) is not readily available. Therefore, randomizing 50% of 
the enrolled midwives to a delayed intervention phase will allow us to collect high quality 
internal baseline data that can be used to make comparisons to the early intervention arm 
(e.g., to compare rates of referral). At the 6 month time-point, all midwives who did not 
initially receive the technology will do so, which will allow all participating midwives to 
benefit from the training and technology by the end of the project.  
 
In the proposed work site, midwives attend on average 10-20 births per year. This means 
that, over 12 months of implementation, we will have the opportunity to collect process 
and outcomes data on a minimum of 500 pregnant women and neonates. We will restrict 
enrollment of pregnant women to those who are older than 18 years of age. This is the legal 
age of consent in Guatemala, and this is a necessary arrangement to ensure that only 
consenting adults are participating in the project, as opposed to minors who are pregnant. 
The average age of first pregnancy in the region is 22 years of age, so the number of 
pregnant women who are excluded from the project due to being legal minors will be 
minimal. Selection of patients will be on an ad hoc basis, based on the willingness and 
availability of patients.  

 
Data collection will be coordinated by field staff from Wuqu’ Kawoq, the collaborating 
local partner. In the early intervention arm, all data will be doubly entered onto paper 
forms and into the mHealth/EMR interface directly by collaborating midwives. In the later 
intervention arm, data will initially be entered only on paper forms by midwives and then, 
after receipt of the technology, will also be entered into the mHealth interface. Wuqu’ 
Kawoq field staff will collect the paper forms and check them against the EMR for 
accuracy. After coding into the EMR, paper forms will be destroyed.  
 
Sources of Materials.  
 
The research material that will be collected from human subjects will be of two forms. 
First, in the case of participating midwives, tests of knowledge and competence with the 
technology and mHealth interface will be administered by project staff. Performance data 
on these tests will be tabulated in an electronic spreadsheet, where each midwife will be 
identified by a unique identification number. A separate master sheet linking these unique 
numbers to each participating midwife will be maintained, accessible only by the principal 
investigators. At the end of the data entry and data cleaning phases, this master sheet will 
be destroyed. All data will be stored on a secure, HIPAA-compliant server.  
 
Second, demographic and health outcomes data will be entered on each participating 
pregnant woman and resulting neonate into both paper forms and the mHealth interface. 
Paper forms will be collected by local field staff, checked against the EMR for accuracy, 
and then immediately destroyed. Each patient entered into the EMR in this way will have 
a unique electronic medical record number, and the project’s principal investigators will 
maintain a list of these medical record numbers on a secure, HIPAA compliant server. 
Only the PI’s will have access to this list. At the end of the project, this list will be used to 
extract the relevant outcomes data from the EMR, at which point the data will be 
deidentified and the master list of medical record numbers will be destroyed.  
 
No identifiable data will be removed from the Wuqu’ Kawoq servers, and will be de-
identified before being downloaded to Emory University servers in the United States.  
 
Potential Risks to Participants  
 
The potential risks to participants from this project are minimal. For participating 
midwives, there is the potential risk that early randomization to the technology will create 
resentment among midwives who receive late randomization to the technology. To 
minimize this risk, all participants will receive an extensive orientation to the project 
design to the need to collect baseline data from half of the participants. Participants will 
also be reassured that all will receive equal training and access by the end of the project.  
 
The risks to participating pregnant women and neonates are also minimal. The 
technologies that will be used in the project are well validated and noninvasive (Doppler 
ultrasound, pulse oximetry, and automated blood pressure) and routinely used worldwide 
in standard of care prenatal health. Therefore, no new or invasive technologies that might 
pose a risk to pregnancy outcomes will be employed. Furthermore, the algorithms that the 
mHealth interface will employ are highly conservative and designed to promote referral to 
physicians and to higher levels of medical care. In other words, the algorithms are 
designed never to “downgrade” an individual midwife’s level of clinical concern and would 
the decision support component would never suggest against medical referral. This means 

that the risk that the project would decrease health care access or falsely reassure 
midwives against a referral is minimal.  
 
There is also risk of psychological stress or stigma to participating pregnant women who, 
for cultural or family reasons may choose to conceal the fact of their pregnancy to all but 
the consulting midwife. Participating in this project may contribute to inadvertent 
disclosure of pregnancy status to community or family members. In order to minimize this 
risk, project staff will limit direct interactions with enrolled pregnant women during the 
course of the project after obtaining consent. In other words, confidentiality and intimacy 
in the patient-midwife relationship will be maintained to the greatest degree possible. 
Project staff will interact only with the midwife and will collect relevant data only from the 
midwife, off-site and not within the community.  
 
One final risk is that incorrect use of the technology may lead to a reading of an absent, 
excessively low or excessively high heart rate, and the relating of this information to the 
patient would lead to unnecessary emotional stress. Although our device is specifically 
designed to avoid such scenarios we will provide specific training to the midwives at the 
WK main site. We will follow standard training patterns, familiar to the midwives, for 
assembling midwives in small groups in a training room, which simulates the rural 
environment. The research team will provide training to the consented midwives using 
volunteer pregnant women. Training will be given on: 
 
- How to interact with the consenter to allow non-coercive consent prior to any use of the 
study equipment or discussion of its utility. 
- How to explain what they are doing during the data collection. 
- How to answer questions about data use (after consent). 
- How to use the device to obtain a good signal, and recognize when the signal is poor. 
- How to ensure data is saved and later uploaded. 
- How to label the data back to the patient in a de-identified manner if required. 
- How to react to scenarios that may lead to stress on the patient such as: 
 -- Finding no heart beat  
 -- Heartbeat is too fast/slow  
 -- Device does not work 
 -- Device feels 'uncomfortable' 
(In the first two cases the midwife would not reveal a problem initially to the patient, but 
will be trained to talk to a back-up Wuqu’ Kawoq physician directly prior to disclosure).  
 
In order to participate in the study, the midwife will have to be able to use all parts of the 
device correctly, and react correctly in the above scenarios. The study coordinator will 
assess each of the midwives for passing this test and certify that they are ready to 
participate.  The study coordinator will also visit midwives at random in the study 
environment and identify deviations from the protocol requiring retaining and 
recertification. 
 
 
 
 
 
Adequacy of Protection Against Risks 
 
Recruitment and Informed Consent  

 
Written or verbal informed consent will be obtained from all participating midwives and 
also from all pregnant patients of each participating midwife. There are two distinct 
settings and population for consenting study participants. The first group of participants 
is the midwives, who will be recruited and consented by the study coordinator at Wuqu’ 
Kawoq. Midwives in Wuqu’ Kawoq’s catchment area will be contact by phone by the study 
coordinator to assess interest in the project. If a midwife expresses interest in participating 
they will be invited to a preliminary training session. During this training session, project 
staff (and in particular the study coordinator) will describe the full details of the study to 
potential midwife participants, including the nature of the subject’s involvement in the 
study, the possible risks and benefits of participation, and the individual capacity to 
withdraw from the study at any time without consequence. The midwives will have the 
opportunity to ask questions about the study, after which consent to proceed will be 
obtained. The study coordinator will receive training in human subjects protection (e.g., 
CITI or the NIH module) prior to interacting with and obtaining consent with midwives.  
 
The second group of participants that requires consenting is the pregnant mothers.  All 
pregnant patients of each recruited midwife will be eligible for participation. Participating 
midwives will be encouraged to mention the study to all of their patients and to relay any 
potential interest in participating to the study coordinator. When a midwife identifies a 
pregnant subject for potentially participation, a single study staff member (a trained nurse 
working under the supervision of the study coordinator) will discretely visit the patient 
(and the biological father, if appropriate), at a location of their choosing (most likely to be 
the domicile of the pregnant patient) and again describe the details of the study, the risks 
and benefits, and the capacity to withdraw at any time without consequence, at which 
point verbal consent will be obtained for collection of data both during the pregnancy and 
in the neonatal period.  
 
Both midwives and patients will all be bilingual speakers of Spanish and Kaqchikel Maya. 
Spanish is the language that they use for technical conversations, such as medical 
conversation. Kaqchikel is an oral, non-written language that is used in more colloquial 
settings. Therefore, consent (and consent documents) will be obtained in Spanish, 
although research staff will be able to speak both languages. We anticipate that some 
informal conversation and question answering will occur in Kaqchikel, after the formal 
consent has been read, as this is typical of medical consultations and interactions in the 
region: technical conversation in Spanish followed by informal clarification in Kaqchikel.  
In our previous experiences, we have been able to obtained written informed consent 
successfully, as long as attention is paid to providing clear orientation and allowing time 
for informal clarification and question answering. Wuqu’ Kawoq’s field staff all are native 
Spanish and Kaqchikel Maya speakers.  
 
 
Protection Against Risk 
 
Confidentiality To protect confidentiality, the following steps will be taken: All paper 
research forms will be kept in locked file cabinets and will be available only to research 
staff directly involved in this project. Immediately after checking paper forms against the 
mHealth/EMR interface, they will be destroyed. The EMR will be maintained on a secure, 
HIPAA-compliant cloud server, and only the principal investigators will have access to the 
EMR directly. Master lists of participating midwives and patients will be keyed to unique 
identifying numbers, and only the project principal investigators will have access to these 

keys, which will also be maintained separately on a secure, HIPAA-compliant cloud server. 
One data extraction and cleaning has been completed, these master lists will be destroyed, 
and data in the analysis phase will be completely deidentified. Laptop computers or tablets 
used for data entry will be routinely backed-up and will be password-protected and 
encrypted. 
 
Additional Protections for Pregnant Women, Fetuses and Neonates. This research 
involves the collection of demographic and health outcomes data on pregnant women and 
neonates. Importantly, the interventional component of the study involves an 
mHealth/EMR integration step and does not introduce novel or experimental 
technologies. All technologies that will be used in the mHealth arm are standard-of-care 
technologies (Doppler, blood pressure monitoring, pulse oximetry). Half of the enrolled 
participants will initially not receive any intervention. However, they will receive the 
current standard of care by lay midwives, with no interference in this usual process. 
Furthermore, for pregnant women and neonates who access the technology (either in the 
early access or later access arms), the expected result of the technology will be earlier and 
more timely referral to a higher level of medical care. At no point will the technology 
discourage accessing a higher level of care. Since the project holds out the potential for 
direct benefit to the pregnant woman and/or her fetus, consent will be obtained directly 
from the pregnant women to participate as outlined in 45cfr46 subpart B. The proposal 
does not include any inducements to early termination of a pregnancy, and it does not 
explicitly involve research on neonates of uncertain or non-viability, although in 
accordance with the proposal’s plan to increase early access to medical care for all 
neonates, rates of neonatal mortality will be tracked.  
 
Additional Protections for Children. This study involves collection of neonatal mortality 
rates and rates of early evaluation of neonates by a postnatal health care delivery team. As 
such, no direct interventions on children will be performed, and the study involves 
minimal risk to children. As outlined above, consent will be obtained from both biological 
parents at the time of enrollment of the pregnant patient in the study to permit collection 
of this data.  
 
The study will not enroll pregnant patients prior to the legal age of informed consent in 
Guatemala (18 years).  
 
Adverse Events. In the event that midwives either in the early technology access or later 
access arms detect the need for a referral to a higher level of medical care or an adverse 
event, they will be instructed to proceed with arranging the referral through the usual local 
mechanisms. However, the local site partner, Wuqu’ Kawoq, will also designate a medical 
officer to assist with the project, and this physician will be available to all midwives 
throughout the duration of the project to provide further logistical and decision support 
for arranging referrals and management of adverse events.  
 
Potential Benefits to Study Participants  
Participants are likely to benefit directly from this project. Midwives will benefit by gaining 
access to additional medical knowledge and technology. Pregnant women and neonates 
will benefit by earlier detection of the need for medical referral and improved care 
coordination. The risk of the project are minimal, and the potential benefits of the project, 
which include the demonstration that mHealth technology can be used to enhance the care 
provided by lay midwives in a developing country setting where perinatal outcomes and 
care coordination are generally poor outweigh these risks.  

 
 
Importance of the Knowledge to Be Gained 
The information gained through this project will contribute important, practical insights 
into the implementation of a mHealth solution to low rates of medical referral and care 
coordination for pregnant women and neonates. These are perennial public health 
problems in rural Guatemala which have until now proven to be largely intractable. In 
addition to suggesting new avenues for enhancing care in rural Guatemala, the results will 
also be applicable to other rural populations in other developing countries which 
experience similar breaks in the primary care referral chain and the continuum of care.  
 
 
 
Institutional Review Board Coverage 
 
The project will be supervised by the IRB of Emory University. In addition, the study will 
also be reviewed and approved by the IRB of the local implementing partner, Wuqu’ 
Kawoq. Both of these institutions have OHRP approved IRBs with FWA. All field staff 
participating in the project will approve an on-line course on the protection of human 
subjects participating in research.  
 
Inclusion of Women and Minorities 
 
Study participants will include 50 lay midwives from the department of Chimaltenango in 
rural Guatemala. Midwives in rural Guatemala are all female for cultural reasons. All 
participants will likely be of Maya ethnicity. Although there will be no restrictions in terms 
of ethnicity for enrolment, the area in which the study is taking place is composed almost 
exclusively of ethnic Maya speaking the Kaqchikel language. Indeed, the purpose of the 
study is to explore ways to improve maternal and child outcomes in this 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. See Targeted/Planned Enrollment Table for projected target sizes of subgroups 
based on gender and race/ethnicity. 
 
 
Inclusion of Children 
 
Because of the stigma associated with teenage pregnancy, and our desire to involve any 
elevated risk of stigma by inadvertently identifying teenage pregnancies against their will, 
only pregnant woman above the age of legal consent in Guatemala (18 years) will be 
included in the project.  
 
Neonates who are born to consenting parents during the project, and data on neonatal 
referrals and mortality will be collected from the electronic medical record. No neonates 
born to consenting parents will be excluded from this data collection.  
 
 
FDA submission  
 
Results from this project will no be sent to the FDA. 
 
 

 
 
Targeted/Planned Enrollment Table shows projected target sizes of subgroups 
based on gender and race/ethnicity. 
 
Study 
Title: 
 
Mobile Health Intervention to Improve Perinatal Continuum of Care 
i
l
Total Planned Enrollment: 
1050 
 
TARGETED/PLANNED ENROLLMENT: Number of Subjects 
Ethnic Category 
Sex/Gender 
Females 
Males(*) 
Total 
Hispanic or Latino 
800 
250 
1050 
Not Hispanic or Latino 
0 
0 
0 
Ethnic Category: Total of All Subjects * 
800 
250 
1050 
Racial Categories 
 
American Indian/Alaska Native 
800 
250 
1050 
Asian 
0 
0 
0 
Native Hawaiian or Other Pacific Islander  
0 
0 
0 
Black or African American  
0 
0 
0 
White 
0 
0 
0 
Racial Categories: Total of All Subjects * 
800 
250 
1050 
* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of 
All Subjects.”  ** Any children born in the study are considered part of the enrollment. With 
500 anticipated births, 50% of these are anticipated to be male