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

Talita Colombo

Status: Not yet enrolling

Conditions: Prenatal Stress; Pregnancy; Mental Disorders; COVID-19 Pandemic

Treatments: Other: Telemedicine appointment; Other: Face-to-face appointment

Study type: Interventional

Funder types: Other

Identifiers

NCT05745896

48740621.9.0000.5335

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

Pregnants at usual care attending appointments in-person.

Treatment:

Other: Face-to-face appointment

Telemedicine Prenatal Care

Experimental group

Description:

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

Treatment:

Other: Telemedicine appointment

Other: Face-to-face appointment