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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-03-01

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Pregnancy; Mental Disorders COVID-19 Pandemic Prenatal Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A superiority randomized clinical trial (RCT), comparing usual care against telemedicine prenatal care. The allocation ratio is a proportion of 1:1 and the maximum follow-up will last 41 weeks (6 weeks pregnancy to 6 week postpartum).

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Adequate masking will be tentatively done by ensuring the allocation concealment, mitigating possibilities of masking violations by outcomes assessors. In addition, an electronic case report form system will be used in a de-identified manner. Only study's chairs will have access to codes. Finally, interim and final analysis will be done in the same manner after dataset locking.

Study Groups

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Usual Care

Pregnants at usual care attending appointments in-person.

Group Type ACTIVE_COMPARATOR

Face-to-face appointment

Intervention Type OTHER

Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.

Telemedicine Prenatal Care

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

Group Type EXPERIMENTAL

Telemedicine appointment

Intervention Type OTHER

Three online appointments for pregnancy monitoring at prenatal care.

Face-to-face appointment

Intervention Type OTHER

Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.

Interventions

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Telemedicine appointment

Three online appointments for pregnancy monitoring at prenatal care.

Intervention Type OTHER

Face-to-face appointment

Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes