A Telemedicine Prenatal Care Model on Low Risk Pregnants: An Effectiveness Randomized Clinical Trial (The m@Mae-e Study)
Phase: NA
Conditions: Pregnancy; Mental Disorders, COVID-19 Pandemic, Prenatal Stress
Sponsor: Talita Colombo

 
 
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COVER LETTER 
 
Official Title: A Telemedicine Prenatal Care Model on Low Risk Pregnants: The 
m@Mae-e Study. 
 
 
 
NCT number: 48740621.9.0000.5335 
Document date: 23th February, 2023.  
 
 
 
 

 
 
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DECLARATIONS 
 
Ethics Approval and Consent to Participate 
The proposed study was designed based on ethical and scientific requirements for 
research involving human beings, presented in the Resolution by the Health National 
Committee of the Ministry of Health 466/12 (22). The project was approved by the 
IRB of the Irmandade Santa Casa de Misericórdia of Porto Alegre (Resolution 
4.915.640) and in accordance with international recommendations for clinical 
research and interventions in human beings. Pregnant women will be required to 
read the informed consent and confirm their interest in participating in the research 
before study entry. As a direct benefit, all pregnant women will be invited to 
participate in online educational activities during prenatal care and will have a 
puerperal consultation, in which they can reply to the questions about breastfeeding, 
baby care, and contraception and have their mental health assessed. With regards 
to risk that might apply to this research, it implies that there will be a lower personal 
contact assessments for those pregnant women allocated to telemedicine prenatal 
care model, even though they will have availability to access to wearable and 24/7 
and also access to obstetric emergence, whenever necessary. 
 
Consent for publication: Not applicable.  
 
Availability of data and materials 
Summaries of the results and other relevant information will be published on the 
eRegistries website. All data generated or analysed during this study are included in 
this published article (and its supplementary information files). 

 
 
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Competing interesting 
Authors declare no competing interesting. 
 
Funding: This study has no financial support. It is a part of the CAPES Research 
Edict for Emergency Selection III CAPES - Telemedicine and Physicians Data 
Analysis - TELEMEDICINE1666049P. 
 
Author´s contributions: Conceptualization, Methodology, Data curation, Writing-
Original draft, Writing - Review & Editing: TC, AS, LC. Methodology, Data curation, 
Data Visualization and Analysis: AJB, BNF. Data Visualization and Analysis: SCC, 
CDT. All authors contributed to interpretation of the data, revision of the manuscript, 
and approved the final manuscript. AS is the guarantor. The corresponding author 
attests that all listed authors meet authorship criteria and that no other meeting the 
criteria has been omitted. 
 
Acknowledgements: We are grateful to Mario Totta Maternity and Santa Casa de 
Misericórdia staff and resident doctors, who will support the data collection process. 
We also appreciate the research team members and the mothers and their babies 
who voluntarily participated in the study. 
 
 
 
 
 
 

 
 
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ABSTRACT 
 
Background: COVID-19 pandemic and its social isolation has increased awareness 
of barriers to obstetric care, resulting in lower access for pregnant and postpartum 
women and forcing health care providers to redesign antenatal care service models. 
The adequacy of the Brazilian prenatal care model aims to ensure attendance, even 
in situations of high logistical complexity. Methods:  This is a superiority hypothesis 
randomized clinical trial protocol, comparing telemedicine prenatal care to traditional 
prenatal care for low-risk pregnancies. This is an unstratified 1:1 allocation ratio, with 
a follow-up of 41 weeks (IG: 6 to 41 weeks and 06 weeks postpartum). This study 
also includes pregnant and postpartum women assessment of anxiety and economic 
evaluation of this new technology proposed. Results: We proposed a model of 
telemedicine prenatal with at least 6 in person appointments and 3 online 
appointments for low-risk pregnant women, based on guidelines of international and 
national guidelines, the study only will be start after research protocol publication and 
peer reviews. Discussion: The development of a guideline for a hybrid in-person-
virtual prenatal care model aiming at reducing face to face medical appointments  
may lead to lower costs and decrease transmission of SARS-CoV-2 in the 
community, in with, activities will enable a similar  effectiveness, and no reduction to 
the quality of care. Trial Registration: 48740621.9.0000.5335. 
 
Keywords: prenatal care, COVID-19, telemedicine, health technology assessment, 
management guideline, randomized clinical trial. 
 
Trial registration: 48740621.9.0000.5335. Approved at DATA, 2023.  

 
 
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BACKGROUND 
 
COVID-19 is a viral infection caused by SARS-CoV-2, which spreads primarily via 
respiratory droplets during close face-to-face contact (1). Pregnant women are 
known to be disproportionately affected by respiratory illnesses, which are 
associated with increased infectious morbidity and high maternal mortality rates (2).  
In this scenario, many expecting mothers are unable to visit the clinician or health 
center, especially in developing countries; this might lead to missing out on high risk 
factors in due course of pregnancy (3). Remote care enables a provision of obstetric 
care at contingency plans, in order to minimize antenatal visits, as it limits an 
exposure to SARS-CoV-2 for healthy pregnant women and also for healthcare 
providers (4). Telemedicine can potentially mitigate potential adverse effects of 
reduced antenatal visits. Several studies have shown that telemedicine is an 
effective strategy, in which applying evolving telemedicine capabilities can improve 
good quality care for obstetric patients (5).  A systematic review suggests that 
obstetrical telemonitoring has a great potential for contributing with better gestational 
outcomes, early detection of complications, prevention of intercurrences, and 
providing rapid intervention even before hospitalization (6). Some studies suggest 
that reduced-frequency prenatal care model, technology-enhanced, is as safe as the 
standard model of care for low-risk pregnant women (7). Although, there is low-grade 
evidence published, Brazil has an incipient regulation of telemedicine and, therefore, 
most prenatal care has been conducted face-to-face. Here we describe a research 
protocol of a study whose objective is to assess the feasibility of conducting a 
randomized controlled trial on the effectiveness and the cost-effectiveness of 
prenatal care telemedicine.  The null hypothesis to be tested in this study is that 

 
 
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there is no difference in (cost-) effectiveness on maternal health outcomes between 
patients undergoing standard prenatal care compared to those receiving 
telemedicine for prenatal care.  
 
 
METHODS/DESIGN 
 
Unblinded, parallel group, randomized controlled trial 
Superiority randomized controlled trial (RCT), comparing standard prenatal care and 
telemedicine prenatal care, with allocation ratio 1:1 and maximum follow-up 41 
weeks (6 weeks pregnancy to 6 week postpartum) will be conducted. The primary 
outcome will be maternal anxiety and clinical effectiveness of both approaches. The 
SPIRIT guidelines (8) will be applied to assess the current RCT, and it is included in 
Appendices. A cost effectiveness study will also be conducted in the present study. 
The trial is registered to the International Standard Randomized Controlled Trial 
Number 48740621.9.0000.5335. 
 
Setting 
This study will be conducted at Santa Casa de Misericórdia of Porto Alegre - Santa 
Clara Hospital - Mario Totta Maternity (MTM), a teaching institution for residency and 
academic training in obstetrics. On average 3000 pregnant women attend prenatal 
care at MTM, by Brazil's Public Health System – the SUS (Unified Health System) 
every year, 14% of which are considered low- risk pregnancies. The MTM catchment 
area includes local, metropolitan and also regional population and has approximately 
3000 deliveries per year.  

 
 
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Participants  
The population of study includes every pregnant woman who seeks care in the 
obstetric outpatient clinics at Santa Casa antenatal care, by SUS and is classified as 
a low-risk pregnant. Those women who attend their first antenatal care at 6 to 12 
weeks gestation at MTM using the public health system (SUS) will be screened for 
this study. We will classify low-risk according to the Brazilian Ministry of Health 
criteria, which includes patients that have no individual or social risk factors or history 
of previous obstetric complications, or any disease or condition that may interfere 
negatively in the pregnancy course (9). This criteria has been validated in several 
studies that had been carried out in Brazil, in which the prenatal care model is 
focused on well-being and safety of low-risk pregnant women (7) (10) (11). 
 
Eligibility criteria   
Inclusion criteria: Low-risk pregnant women, age between 18 to 34 years; gestational 
age less than 13 weeks at the first consultation and Portuguese native speaker. 
Exclusion criteria: Patients with clinical evaluation of high-risk pregnancies will be 
excluded, including chronic hypertension, diabetes mellitus, obesity, multiple 
pregnancies, severe COVID-19 infection, previous thromboembolic event, acute or 
chronic hematological events (eg, thrombus formation isolated to thrombophilia), use 
of 
anticoagulants, 
cardiovascular 
disease, 
lung 
disease, 
kidney 
disease, 
immunosuppression, severe mental disorder, recurrent abortion, previous premature 
birth, previous or current cancer. 
 
 
 

 
 
Sample size and power ca
The sample size calculation
scores on the GAD-7 anxie
standard deviation of 4 poin
80% power, at the 5% sign
the final size of the intend
until target sample size is r
superiority randomized clin
Figure 1: formula for superi
 
Recruitment  
The recruitment populatio
antenatal visit at 6 to 12 we
until completion of the post
Eligible participants will rec
benefits in adapted langua
form (Appendices). 
 
Randomisation  
The randomization process
similar numbers of particip
alculation  
n was based on the primary outcome - di
ety scale -, compared to means, estimate
nts. A sample of 26 patients each group i
nificance level; considering losses of 15%
ded sample will be 60 patients. Recruitm
reached. The sample was calculated usin
ical trials proposed by WANG et al., 2017
 
iority randomized clinical trials. 
on includes pregnant women presentin
eeks of gestation. Participation in the stud
partum period.  
ceive information about study design, obj
age, participant information leaflet and pa
s in this RCT will use random permuted 
pants in each intervention arm through
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ifference between 
d at 4 points, and 
is needed to have 
% in the follow-up, 
ment will continue 
ng the formula for 
7 (Figure 1):  
ng for their first 
dy will be followed 
ectives, risks and 
articipant consent 
blocks to ensure 
hout the trial and 

 
 
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equal numbers in each arm by the end of the study. Blocks of varying length will be 
used to reduce the predictability of the allocation sequence. In advance of participant 
recruitment, an independent researcher will be responsible for generating the 
allocation sequence using the Stata program (version 2.0). Sealed envelopes will be 
used to assign participants to intervention groups. Thus, the allocation sequence will 
be concealed from all study researchers until the interventions are assigned, unless 
major adverse events or unexpected inconsistencies occur in the follow-up to the 
study.  
 
Interventions  
All eligible women who consent to participate in the study will be randomized into 
either usual prenatal care (UPC) or telemedicine prenatal care (TPC). The antenatal 
scheduling process will be similar between groups.  In the UPC all appointments (at 
least 9) will be in person. Participants assigned to the TPC group will perform at least 
6 in person appointments and 3 online appointments through the Google Meet 
platform; this group will have wearable for blood pressure and fetal heart home 
monitoring, as needed according to the guidelines defined previously by the 
Obstetric Outpatient Department. Consent for teleconsultation and medical device 
use at home will be obtained. In situations where Google Meet or internet isn't 
available, the appointments will be carried out by video call. Pregnant women from 
both arms of the study will receive standard care from the obstetric team. Clinical 
management will be based on evidence-based guidelines used at MTM, which is 
currently being revised to include remote antenatal care and will be finalized and 
available before collection of data. Santa Casa Hospital will provide all necessary 
laboratory and imaging tests. Participants from both arms of study will be advised to 

 
 
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seek obstetric emergency in case they are feeling some discomfort or pain, have any 
complications or need any further evaluations. 
 
Variables and data collection 
Data collection has four components: baseline demographic characteristics, quality 
of life and economics data, anxiety scores and clinical outcome data. Undergraduate 
medical students and Gynecology and Obstetrics residents, trained in conducting 
diagnostic assessments, will collect data and apply the standardized questionnaires.  
In order to compare participants in both arms, data on clinical risk factors and 
socioeconomic status will be collected during the recruitment phase, using the 
baseline characteristics questionnaire (Table 1).  
 
Chart 1: Baseline characteristics questionnaire 
 
 
Outcome variables  
Severity of anxiety among pregnant women and postpartum women will be 
evaluated by GAD-7 scale (Chart 2), which has been validated for assessing anxiety 

 
 
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in pregnant women, in a study developed by Zhong and collaborators (13). This 
scale had good reliability, internal and external validity; patients with scores greater 
than or equal to 07 required careful follow-up (13).  
Health-related quality of life will be assessed using the Portuguese version of the 
EQ-5D (Chart 3) (14). This questionnaire was developed by the EuroQol group and 
is recommended by Health Technology agencies worldwide as a key outcome 
measure for the use in cost-effectiveness analysis (15). The EQ-5D includes five 
dimensions of health (i.e., mobility, self-care, usual activities, pain/discomfort and 
anxiety/depression) which are used to describe the health state of the participants 
according to 3 levels of response (no problems, some problems and extreme 
problems) resulting in 243 health states. The participants’ health states obtained 
from the EQ-5D responses will be scored using the Brazilian value set (12).  
 
Chart 2: GAD-7 scale 
 
 
 
 
 
 

 
 
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Chart 3: EQ-5D questionnaire 
 
 
Four categories of costs will be collected: (1) Intervention costs and usual care costs, 
(2) Healthcare costs (i.e., medication costs, primary, secondary, and tertiary costs), 
(3) Informal care costs (i.e., transportation costs, caregiver costs, internet costs), and 
(4) Lost productivity costs. Intervention costs will be calculated using a bottom-up 
approach in which the resources consumed by the intervention will be collected (i.e., 
minutes spent in the teleconsultation by the obstetrician). Costs related to the use of 
health services (i.e., healthcare costs) and costs incurred by the patient and family 
(i.e. informal care costs) will be measured using an adapted version of 
questionnaires developed by Vidal and collaborators (16) and by researchers of the 
Stringer study (17) (Chart 4). Lost productivity costs (i.e., absenteeism from work 
and presenteeism) will be measured using an adapted version of the iProductivity 

 
 
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Cost Questionnaire (iPCQ) developed by researchers of the Institute for Medical 
Technology Assessment (iMTA) (18). All costs will be measured at prenatal 
trimestral appointments and will cover the period between appointments (i.e., 3 
months). Costs will be evaluated according to the to the Brazilian Public Health 
reimbursement table of  Sistema de Gerenciamento da Tabela de Procedimentos, 
Medicamentos e OPM do SUS (SIGTAP)(19), to the Instituto Brasileiro de Geografia 
e Estatística (IBGE)(20).  
 
Chart 4: Costs related to prenatal care. 
 
 
Clinical outcomes will be collected to explore the clinical effectiveness of the TPC 
based on hospital database reviews (Chart 5). 
 
 
 
 

 
 
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Chart 5: Maternal-fetal outcome and puerperal aspects 
 
 
Outcomes 
Primary outcome: Mean between-group differences in GAD-7 scores. 
Secondary outcome 1: difference between means, between groups, of data related 
to the mother: delivery mode and obstetric complications. 
Secondary outcome 2: difference between means, between groups, of data related 
to the baby: gestational age at birth, birth weight, APGAR, neonatal intensive care 
unit (ICU) admission. 
Secondary outcome 3: economic analyses. 
The quality of assistance will be evaluated by the Humanization Program for 
Prenatal and Birth (PHPN) criteria proposed by Brazil Ministry of Health (21). 
Adherence to the proposed care will be assessed by attending the consultations, 
carrying out the proposed exams and extra consultations in the Obstetric 
Emergency. The schedule intervention was present at Figure 2. 
 
 
 
 

 
 
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Figure 2: Flow Chart of recruitment, intervention and evaluations 
 
 
Analysis plan  
This RCT will have an analysis by intention-to-treat and per protocol (at least 6 
sessions attended) since it is an RCT of effectiveness. The primary outcome will be 
analyzed by generalized linear models of mixed effects (GLMM) or by generalized 
estimation equations (GEEs). Adjustments for confounding or baseline variables may 
be made if justified. Secondary outcomes can be analyzed in 2-test linear models 
using the Mantel-Hanszel test, linear trends for ordinary categorical variables or 
multivariate regression models for categorical variables. For repeated measures, the 
same analysis of the primary outcome (GLMM or GEEs) will be maintained. The 

 
 
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level of significance for the statistical tests conducted will be 5% and effect estimates 
will be presented with 95% confidence intervals. 
The cost-effectiveness and cost-utility analysis will be carried out following the 
intention-to-treat principle according to the randomized clinical trial dataset (22) in 
software R. The differences in cost and effect will be estimated using a set of 
equations of apparently non-correlated regressions, which adjusts the model to 
correlate costs and effects and also allows adjustment for potential confounding 
factors. The incremental cost-effectiveness ratio (ICER) will be calculated by dividing 
the difference in costs between interventions by the difference in effect between 
interventions. Bias-corrected accelerated bootstrapping with 5000 replications will be 
used to estimate uncertainty around costs and effects. The cost-effect pairs, results 
of 5000 bootstrapping replications, will be plotted in cost-effectiveness plans (CE-
plan) (23). The cost-effectiveness acceptability curves (CEACs) will be estimated to 
show the probability that the intervention will be cost-effective compared to the 
control, in different amounts of willingness to pay (that is, the amount in Reais that 
the health system is willing to pay per unit of effect won) (23). Multiple imputation will 
be used to predict missing data. The data imputation model will include variables 
associated with the missing data (24). 
 
Data protection and participant confidentiality  
Data acquired according to this protocol will be stored in a password-protected 
database on a secure network. All entries will be made by an authorized member of 
the investigator’s staff. Data will be entered into the study database and verified 
through the use of programmed edit checks for accuracy and completeness. The 
corrected data and a complete audit trail of corrections will be retained. An internal 

 
 
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audit of a sample of the data will be conducted quarterly to assure quality. The 
investigator will ensure that participants’ anonymity is maintained. Participants will 
not be identified by their names, but by their assigned identification number and 
initials. Signed informed consent forms, will be maintained securely. Only authorized 
members of the investigator’s staff will have access to the final trial dataset. All 
information regarding the study data or results supplied to the investigator is 
privileged and confidential information. The investigators agree to use this 
information to accomplish the study and will not use it for other purposes.  
 
Safety management 
The research team will be composed of a principal investigator, co-investigators and 
a trial statistician. A data monitoring committee is not required as the study 
management group will liaise every month to review interim analysis and monitor 
adherence. The principal investigator will make the final decision to terminate the 
trial in the event that uptake rates fall below pre-trial levels in either intervention arm. 
It is not anticipated that there will be premature ends of study. However, if this 
occurs, then the data will be analyzed and results circulated among the team 
members. The ethics committee will be notified of any premature termination and the 
reasons for termination. Adverse events or other unintended effects of trial 
interventions that come to the attention of trial investigators will be reported 
immediately to the study management Group. All protocol amendments will be 
submitted to the ethics committee for review and approval before implementation 
and to trial registries. 
 
 

 
 
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Trial status   
This study protocol aims at disseminating and discussing a new model of prenatal 
care. It will be presented at the IRB of the Irmandade Santa Casa de Misericórdia de 
Porto Alegre and after approval the recruitment will start.  
 
Dissemination policy 
This protocol follows the Standard Protocol Items for reporting: Recommendations 
for Intervention trials (SPIRIT) guidelines. We will inform all users and stakeholders 
and publish the results of the CRCT in peer-reviewed open-access journals. The 
final manuscript will be written based on the recommendations of the Consolidating 
Standards of Reporting Trials (CONSORT) guidelines for parallel and superiority 
trials. Results will also be presented at scientific meetings and congresses. We will 
report any change in the study outcomes, study design, sample sizes, or significant 
administrative aspects that will impact the study’s design when disseminating the 
findings. Authorship will be in line with the recommendations of the International 
Committee of Medical Journal Editors. Knowledge translation tools will be carried out 
to disseminate the study for the population. 
 
 
RESULTS 
We proposed a model of telemedicine prenatal with at least 6 in person 
appointments and 3 online appointments for low-risk pregnant women, based on 
guidelines of international and national guidelines, the study only will be start after 
research protocol publication and peer reviews. 
 

 
 
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DISCUSSION 
This study aims the development of a guideline for a hybrid in-person- virtual 
prenatal care model. This new model of care aiming at reducing face to face medical 
appointments, particularly important in COVID-19 pandemic and in distant 
communities, with restricted access to specialists, especially in a country of 
continental dimensions such as Brazil. Complemented by the economic evaluation of 
the proposed new technology, aims to enable a similar effectiveness, with no 
reduction to the quality of care and reduced costs.  
In the scenario of uncertainty of COVID-19 pandemic and in consonance to principle 
of non-malfeasance, pregnant women were recommended to carefully follow the 
non-pharmacological countermeasures, such as social distancing, hand hygiene and 
use of masks, restricting themselves to leave home only for prenatal appointments 
and to perform complementary tests - which, paradoxically, became potentially a risk 
event. Some pregnant women did not attend medical appointments, especially in 
developing countries; as a consequence, screening for gestational risk factors was 
hampere (5). Maternal-fetal care is essential. Pregnant women who do not attend 
antenatal services are at increased risk of maternal death, unfavorable perinatal 
outcomes, and stillbirth. There is evidence of a difference in stillbirth incidence 
between the pre-pandemic and pandemic period reporting 9.31/1000 live births 
versus 2.38/1000 live births, p = 0.01), showing a marked increase in the number of 
stillbirths in the pandemic transition. The adoption of health care models that include 
telemedicine is still a challenge in middle-income countries; however, it is of 
fundamental importance in expanding access and reduces infant and maternal 
morbidity. Despite the pandemic, pregnant women need to follow up on prenatal 

 
 
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care; even if barriers imposed by the situation have to be overcome or new 
approaches to care have to be taken (26). 
Evidence on the impact of the number of antenatal visits on maternal and fetal 
outcomes is limited; similarly, while some studies point to reducing the number of 
visits, home care, and group care as safe, robust clinical trials with comparative 
results are not available (27). A systematic review by Villar concluded that, for usual-
risk pregnant women, a reduction in the number of consultations does not imply 
worse maternal-fetal outcomes. Similarly, a study by Partridge demonstrated that 
fewer than 10 prenatal visits were not associated with worse fetal outcomes such as 
low APGAR, ICU admission, and neonatal death (28). 
The pandemic by COVID-19 and the need for social distance has amplified barriers 
to obstetric care; forcing providers and health systems to rethink access to care (29). 
Often lauded for its ability to increase access to healthcare among geographically 
dispersed patient populations, telehealth has emerged as a strategy designed to 
solve many of these challenges imposed by the pandemic at the local level (29). 
Prenatal care should be provided through the incorporation of welcoming behaviors; 
the development of educational and preventive actions, without unnecessary 
interventions and easy access to quality health services (30). Countries such as the 
United States, Israel, and China already use telemedicine in maternal-fetal care. In 
Pennsylvania, a model of prenatal care via telemedicine, developed to expand 
access to pregnant women living in remote areas, has shown good levels of 
acceptance. In Arkansas, ANGELES - a telemedicine program for monitoring 
pregnant women - has resulted in early identification of high-risk pregnancies, and 
researchers have concluded that the combination of face-to-face and telemedicine 
resources is positive (7). In Canada, a protocol entitled OB Nest was developed to 

 
 
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reduce in-person visits and incorporate telehealth visits into low-risk prenatal care 
and has been shown to provide reduced stress and increased satisfaction among 
patients (6). Despite the difficulties, the use of telemedicine in prenatal care is 
gaining ground, especially for the promotion of lifestyle interventions and prevention 
of complications secondary to gestational diabetes and hypertension (10). A 
randomized clinical trial entitled GLOW was conducted in California with 394 
pregnant women and demonstrated the effectiveness of telehealth in preventing 
gestational overweight and improving levels of insulin resistance in overweight and 
obese pregnant women (10). Favorable results have also been reported Ridgeway 
and colleagues who developed hybrid obstetric care models and by Ridgeway who 
modernized obstetric care at Mayo Clinic Rochester (11). A study involving 300 
pregnant women evidenced that the current routine prenatal and puerperal 
appointments do not match the preferences of patients, who are open to alternative 
models of prenatal care, including remote monitoring (6). 
The development of guidelines on telemedicine services contributes greatly to the 
consistency of services provided and ensures patients safety of services, thus 
developing a guideline for prenatal care through telemedicine is of fundamental 
importance; empowering pregnant women for this new model is to shift the focus of 
care from disease to a state of well-being, especially in usual risk pregnancies (32). 
It is clear that, in the pandemic of COVID-19, the barriers to access prenatal care 
have increased, resulting in risks for pregnant and postpartum women and babies.  
The possible difficulties to be encountered in the development of this research 
protocol refer to the large number of evaluations to be developed with the pregnant 
women throughout the three trimesters of pregnancy and the puerperium. In order to 

 
 
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minimize these issues, we will conduct training for the medical residents involved in 
the research. 
 

 
 
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LIST OF ABBREVIATIONS 
 
SARS-CoV-2 
Randomised controlled trial (RCT) 
Mario Totta Maternity (MTM) 
SUS (Unified Health System) 
Usual prenatal care (UPC)  
Telemedicine prenatal care (TPC) 
ICU intensive care unit 
Humanization Program for Prenatal and Birth (PHPN) 
 Generalized estimation equations (GHGs) 
 Generalized linear models of mixed effects (GLMM) 
Incremental cost-effectiveness ratio (ICER) 
 Cost-effectiveness plans (CE-plan)  
 Cost-effectiveness acceptability curves (CEACs)  
CNS Conselho Nacional de Saúde 
MS Ministério da Saúde 
 

 
 
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FIGURE LEGENDS 
 
Figure 1: Formula for superiority randomized clinical trials proposed by WANG et al., 
2017. 
Figure 2: Flow Chart of recruitment, intervention and evaluations. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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CHARTS LEGENDS 
 
Chart 1: Baseline characteristics questionnaire. 
Chart 2: GAD-7 scale. 
Chart 3: EQ-5D questionnaire. 
Chart 4: Costs related to prenatal care. 
Chart 5: Maternal-fetal outcome and puerperal aspects.