COVID-19 Pandemic Clinical Trial
— m@mae-eOfficial title:
A Telemedicine Prenatal Care Model on Low Risk Pregnants: An Effectiveness Randomized Clinical Trial (The m@Mae-e Study)
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).
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | March 1, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 34 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Irmandade da Santa Casa de Misericórdia de Porto Alegre (ISCMPA) | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Talita Colombo | Hospital de Clinicas de Porto Alegre, Irmandade Santa Casa de Misericórdia de Porto Alegre, McMaster University, VU University of Amsterdam |
Brazil,
Colombo T, Todeschini LB, Orlandini M, Nascimento HD, Gabriel FC, Alves RJV, Stein AT. Low-Risk Antenatal Care Enhanced by Telemedicine: A Practical Guideline Model. Rev Bras Ginecol Obstet. 2022 Sep;44(9):845-853. doi: 10.1055/s-0042-1753505. Epub 2022 Jul 19. — View Citation
Stein C, Helal L, Migliavaca CB, Sangalli CN, Colpani V, Raupp da Rosa P, Beck-da-Silva L, Rohde LE, Polanczyk CA, Falavigna M. Are the recommendation of sodium and fluid restriction in heart failure patients changing over the past years? A systematic review and meta-analysis. Clin Nutr ESPEN. 2022 Jun;49:129-137. doi: 10.1016/j.clnesp.2022.03.032. Epub 2022 Apr 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) |
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