A Telemedicine Prenatal Care Model on Low Risk Pregnants: The m@Mae-e Study

Study Overview
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Brief Summary
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This study will compare the effectiveness of a prenatal care supported by telemedicine against usual care in low-risk pregnant women. The investigators will follow-up women in a gestational age of 6 weeks up to 41 weeks, and 6 postpartum weeks. The primary outcome is the anxiety level estimated by the General Anxiety Scale 7 scale (GAD-7 Scale).

Detailed Description
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This is a pragmatic, effectiveness, superiority randomized clinical trial (RCT), in which low risk pregnants will be randomized to a prenatal care program supported by telemedicine or usual care in an allocation ratio of 1:1. The follow-up period will last 41 weeks from inception (i.e., 6 to 13 weeks of gestational age) to pregnancy and a extension period of 6 weeks in the postpartum stage. The investigators settled anxiety levels estimated by the General Anxiety Scale 7 scale as primary outcome in a between-groups mean difference after the 3rd trimester. Secondary outcomes include: delivery mode, obstetric events and fetal and neonatal variables of epidemiological surveillance interest (birth weight, birth height and APGAR score; maternal, fetal and neonatal fatal and non-fatal events). The interventions will occur as follows: for usual care, all appointments (at least 9 outpatient clinic visits) will be carried forward in person by a senior obstetrician. Patients randomized for the telemedicine supported group should will attend at least 6 in person and 3 online appointments. All pregnant women will receive the standardized care throughout the study. The sample size calculation was based on the primary outcome, assuming between-groups mean difference of 4 points plus a 4-points standard deviation, at a statistical of 80% and a two-tailed 5% type I error. Further, a 15% of addition was done for potential impairments during the follow-up, ending in 30 patients per group. The m@mae-e study's setting will be the at Santa Casa de Misericórdia, (Porto Alegre, Brazil).

Official Title
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A Telemedicine Prenatal Care Model on Low Risk Pregnants: An Effectiveness Randomized Clinical Trial (The m@Mae-e Study)

Conditions
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Pregnancy; Mental Disorders, COVID-19 Pandemic, Prenatal Stress

Intervention / Treatment
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* Other: Telemedicine appointment
* Other: Face-to-face appointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low-risk pregnant (as classified an attending physician and/or the study's obstetrician); Gestational age less at 13 weeks or more in the moment of the first appointment; Portuguese native speaker. Exclusion Criteria: Pregnant involving: hypertension or diabetes mellitus (any type) previous diagnosis; Obesity (BMI equal or greater than 35 m/kg2; Previous diagnosis of severe Sars-CoV-2 2019-related (COVID-19) infection which needed hospitalization; Previous thromboembolic event; Acute or chronic hematological events/diseases; use of anticoagulants or anti platelet aggregation drugs; Chronic cardiovascular, lung or kidney disease and cancer requiring treatment; Immunosuppression state; Severe mental disorder - major depression, generalized anxiety (and others anxiety-related disorders), bipolar disorder, schizophrenia and personality-related disorders in an uncontrolled manner for at least 1 year; At least more than one abortion; History of premature birth; An enrolled patient living in the same house; Plan to move the city.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A superiority randomized clinical trial (RCT), comparing usual care against telemedicine prenatal care. The allocation ratio is a proportion of 1:1 and the maximum follow-up will last 41 weeks (6 weeks pregnancy to 6 week postpartum).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Pregnants at usual care attending appointments in-person. | Other: Face-to-face appointment<br>* Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.<br>|
| Experimental: Telemedicine Prenatal Care<br>Pregnants under telemedicine based group attending at least 6 in-person outpatient clinic appointments and the remaining ones (i.e., 3) online. | Other: Telemedicine appointment<br>* Three online appointments for pregnancy monitoring at prenatal care.<br>Other: Face-to-face appointment<br>* Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety levels in usual care and telemedicine support care groups from inception until the final of the prenatal care (6 weeks postpartum). | Mean between-group differences in General Anxiety Disorder (GAD-7) scale scores. | First measure at baseline, last measure at birth time | 
| Anxiety levels in usual care and telemedicine support care groups from inception until the final of the postpartum period (6 weeks postpartum). | Mean between-group differences in General Anxiety Disorder (GAD-7) scale scores. | First measure at baseline, last measure at the end of postpartum period (6 week postpartum). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary analysis of anxiety levels between usual care and telemedicine support care groups. | Mean between-groups differences in General Anxiety Disorder (GAD-7) scale scores. | Repeated, full comparisons estimates at baseline; 10-12th weeks of pregnancy; 18-24 weeks of pregnancy and 34-36 weeks of pregnancy as well as the postpartum period (4-6 week postpartum) | 
| Maternal fatal and non-fatal outcomes | Cumulative incidence of gestational diabetes diagnosis; high blood pressure events (pre-eclampsia and eclampsia); severe anemia; need to forward to high-risk prenatal care program; cardiovascular events with or without hospitalization; cardiovascular attributable death during pregnancy and postpartum period; maternal attributable underlying cause of death; all-cause mortality. | Assesed at birth | 
| Fetal and neonatal fatal and non-fatal outcomes | Cumulative incidence and mean difference between-groups of: gestational age at birth; birth weight; APGAR score; neonatal intensive care unit (ICU) admission; death by intentional and unintentional abortion; events related to underlying causes of fetal and neonatal periods; fatal events related to underlying causes of fetal and neonatal events | Assesed at birth | 
| Quality of life levels between usual care and telemedicine support care | Mean between-groups differences in the Portuguese validated EuroQoL 5D scores (EQ-5D). | Repeated, full comparisons estimates at baseline; 10-12th weeks of pregnancy; 18-24 weeks of pregnancy and 34-36 weeks of pregnancy as well as the postpartum period (4-6 week postpartum) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prenatal care, covid-19, telemedicine, low risk prenatal line of care, health policy, randomized clinical trial