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

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

Irmandade Santa Casa de Misericórdia de Porto Alegre, McMaster University, VU University of Amsterdam, Hospital de Clinicas de Porto Alegre

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).

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).

prenatal care, covid-19, telemedicine, low risk prenatal line of care, health policy, randomized clinical trial

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).

Adequate masking will be tentatively done by ensuring the allocation concealment, mitigating possibilities of masking violations by outcomes assessors. In addition, an electronic case report form system will be used in a de-identified manner. Only study's chairs will have access to codes. Finally, interim and final analysis will be done in the same manner after dataset locking.

Pregnants under telemedicine based group attending at least 6 in-person outpatient clinic appointments and the remaining ones (i.e., 3) online.

Anxiety levels in usual care and telemedicine support care groups from inception until the final of the prenatal care (6 weeks postpartum).

Anxiety levels in usual care and telemedicine support care groups from inception until the final of the postpartum period (6 weeks postpartum).

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)

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.

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

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)

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.

We added an individual participant data sharing policy (IPD data-sharing) and tabular results will be displayed in this CT.gov in a 12-month range after our primary completion (PC) at max. Third parties interested to use the m@mae-e data should contact the study chair and the study's PI. IPD will be released in a public and safe repository in a de identified manner. Altogether to the raw data, individuals will have access to case report files, the study protocol, materials, SAP and codes.

Open access accompanied by a disclosure form of potential conflicts of interest and Term of Agreement to not make misuse of the data.

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