NCT05745896

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

A Telemedicine Prenatal Care Model on Low Risk Pregnants: An Effectiveness Randomized Clinical Trial (The m@Mae-e Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Talita Colombo · Academic / Other
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pregnancy; Mental Disorders
• COVID-19 Pandemic
• Prenatal Stress

Interventions

Type	Name	Description
OTHER	Telemedicine appointment	Three online appointments for pregnancy monitoring at prenatal care.
OTHER	Face-to-face appointment	Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-12-31
• Completion: 2026-03-01
• First posted: 2023-02-27
• Last updated: 2023-02-27

Locations

1 site across 1 country: Brazil