Pregnancy, Prenatal Care
Conditions
Keywords
Midwives, Pregnant Women
Brief 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 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.
Interventions
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Referral Rates to Local Hospitals | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Referrals | 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. |
Countries
Guatemala
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| TBA - Early Access Arm Traditional birth attendants (TBAs) receiving access to mHealth technology immediately and using it for 12 months | 23 |
| 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 | 21 |
| 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 | 335 |
| 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 | 327 |
| Total | 706 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | TBA - Early Access Arm | TBA - Later Access Arm | Pregnant Women - Early Access Arm | Pregnant Women - Later Access Arm | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 21 Participants | 335 Participants | 327 Participants | 706 Participants |
| Race/Ethnicity, Customized Indigenous Mayan | 23 Participants | 21 Participants | 335 Participants | 327 Participants | 706 Participants |
| Region of Enrollment Guatemala | 23 Participants | 21 Participants | 335 Participants | 327 Participants | 706 Participants |
| Sex: Female, Male Female | 23 Participants | 21 Participants | 335 Participants | 327 Participants | 706 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 2 / 425 | 1 / 374 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 425 | 0 / 374 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 425 | 0 / 374 |
Outcome results
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.
Time frame: Month 12
Population: All pregnant participants are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TBA - Early Access Arm | Number of Neonatal Deaths | 7 deaths |
| TBA - Later Access Arm | Number of Neonatal Deaths | 3 deaths |
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.
Time frame: Month 7, Month 12
Population: All TBAs are included in this analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TBA - Early Access Arm | Referral Rates to Local Hospitals | Month 7 | 33 Referrals per 100 births |
| TBA - Early Access Arm | Referral Rates to Local Hospitals | Month 12 | 31 Referrals per 100 births |
| TBA - Later Access Arm | Referral Rates to Local Hospitals | Month 7 | 20 Referrals per 100 births |
| TBA - Later Access Arm | Referral Rates to Local Hospitals | Month 12 | 34 Referrals per 100 births |
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.
Time frame: Month 7, Month 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBA - Early Access Arm | Successful Referrals | First study period | 69 Referrals to hospital |
| TBA - Early Access Arm | Successful Referrals | Second study period | 48 Referrals to hospital |
| TBA - Later Access Arm | Successful Referrals | First study period | 44 Referrals to hospital |
| TBA - Later Access Arm | Successful Referrals | Second study period | 47 Referrals to hospital |