A Telemedicine Prenatal Care Model on Low Risk Pregnants: An Effectiveness Randomized Clinical Trial (The m@Mae-e Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy; Mental Disorders
- Sponsor
- Talita Colombo
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Anxiety levels in usual care and telemedicine support care groups from inception until the final of the prenatal care (6 weeks postpartum).
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief 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).
Detailed Description
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).
Investigators
Talita Colombo
Talita Colombo, MD, MSc - Principal Investigator
Federal University of Health Science of Porto Alegre
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;
Outcomes
Primary Outcomes
Anxiety levels in usual care and telemedicine support care groups from inception until the final of the prenatal care (6 weeks postpartum).
Time Frame: First measure at baseline, last measure at birth time
Mean between-group differences in General Anxiety Disorder (GAD-7) scale scores.
Anxiety levels in usual care and telemedicine support care groups from inception until the final of the postpartum period (6 weeks postpartum).
Time Frame: First measure at baseline, last measure at the end of postpartum period (6 week postpartum).
Mean between-group differences in General Anxiety Disorder (GAD-7) scale scores.
Secondary Outcomes
- Maternal fatal and non-fatal outcomes(Assesed at birth)
- Fetal and neonatal fatal and non-fatal outcomes(Assesed at birth)
- Secondary analysis of anxiety levels between usual care and telemedicine support care groups.(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))
- Quality of life levels between usual care and telemedicine support care(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))