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

NCT05745896 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-27

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    collaborator OTHER

  • McMaster University

    collaborator OTHER

  • VU University of Amsterdam

    collaborator OTHER

  • Hospital de Clinicas de Porto Alegre

    collaborator OTHER

  • Talita Colombo

    lead OTHER

Principal Investigators

  • Lucas Helal, MSc, PhD · Federal University of Rio Grande do Sul

  • Airton T Stein, MD, PhD · Federal University of Health Science of Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-12-31
Completion
2026-03-01

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05745896 on ClinicalTrials.gov