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

NCT05745896 | Not Yet Recruiting DMC

• 1 other identifier: 48740621.9.0000.5335
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

prenatal care; covid-19; telemedicine; low risk prenatal line of care; health policy; randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• Anxiety levels in usual care and telemedicine support care groups from inception until the final of the prenatal care (6 weeks postpartum).

  Mean between-group differences in General Anxiety Disorder (GAD-7) scale scores.

  First measure at baseline, last measure at birth time

• Anxiety levels in usual care and telemedicine support care groups from inception until the final of the postpartum period (6 weeks postpartum).

  Mean between-group differences in General Anxiety Disorder (GAD-7) scale scores.

  First measure at baseline, last measure at the end of postpartum period (6 week postpartum).

Secondary Outcomes (4)

• 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)

• Maternal fatal and non-fatal outcomes

  Assesed at birth

• Fetal and neonatal fatal and non-fatal outcomes

  Assesed at birth

• 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)

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Pregnants at usual care attending appointments in-person.

Other: Face-to-face appointment

Telemedicine Prenatal Care

EXPERIMENTAL

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

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

Interventions

Telemedicine appointment OTHER

Three online appointments for pregnancy monitoring at prenatal care.

Telemedicine Prenatal Care

Face-to-face appointment OTHER

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

Telemedicine Prenatal Care; Usual Care

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Talita Colombo: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator
• McMaster University: collaborator
• VU University of Amsterdam: collaborator
• Hospital de Clinicas de Porto Alegre: collaborator

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de Porto Alegre (ISCMPA)

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Related Publications (2)

• Colombo T, Todeschini LB, Orlandini M, Nascimento HD, Gabriel FC, Alves RJV, Stein AT. Low-Risk Antenatal Care Enhanced by Telemedicine: A Practical Guideline Model. Rev Bras Ginecol Obstet. 2022 Sep;44(9):845-853. doi: 10.1055/s-0042-1753505. Epub 2022 Jul 19.

  PMID: 35853473 BACKGROUND

• Stein C, Helal L, Migliavaca CB, Sangalli CN, Colpani V, Raupp da Rosa P, Beck-da-Silva L, Rohde LE, Polanczyk CA, Falavigna M. Are the recommendation of sodium and fluid restriction in heart failure patients changing over the past years? A systematic review and meta-analysis. Clin Nutr ESPEN. 2022 Jun;49:129-137. doi: 10.1016/j.clnesp.2022.03.032. Epub 2022 Apr 6.

  PMID: 35623804 BACKGROUND

Related Links

• Repository for study's management.

MeSH Terms

Conditions

Mental Disorders; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lucas Helal, MSc, PhD

  Federal University of Rio Grande do Sul

  STUDY CHAIR

• Airton T Stein, MD, PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Talita Colombo, MD, MSc

CONTACT

+55 51 3024 5657; talitacolombo@ufcspa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Talita Colombo, MD, MSc - Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: February 27, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after primary completion date, for at least 10 years.
• Access Criteria: Open access accompanied by a disclosure form of potential conflicts of interest and Term of Agreement to not make misuse of the data.

Locations

BR (1)