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NCT05745896
A Telemedicine Prenatal Care Model on Low Risk Pregnants: The m@Mae-e Study
Conditions: Pregnancy; Mental Disorders, COVID-19 Pandemic, Prenatal Stress
Sex: Female
Ages: 18 Years – 34 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 60
Sponsor: Talita Colombo
Location: Brazil
Summary
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).
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05745896). StuddyBuddy aggregates publicly available trial information.