This study will compare the effectiveness of a prenatal care supported by telemedicineagainst usual care in low-risk pregnant women. The investigators will follow-up women ina gestational age of 6 weeks up to 41 weeks, and 6 postpartum weeks. The primary outcomeis 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).
Other: Telemedicine appointment
Three online appointments for pregnancy monitoring at prenatal care.
Other: Face-to-face appointment
Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.
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.
Irmandade da Santa Casa de Misericórdia de Porto Alegre (ISCMPA)
Porto Alegre, Rio Grande Do Sul, Brazil
Talita Colombo, MD, MSc
+55 51 3024 5657
talitacolombo@ufcspa.edu.br