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

February 23, 2023 updated by: Talita Colombo

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre (ISCMPA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Pregnants at usual care attending appointments in-person.
Other: Face-to-face appointment
Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.
Experimental: 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.
Other: Face-to-face appointment
Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.
Other: Telemedicine appointment
Three online appointments for pregnancy monitoring at prenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety levels in usual care and telemedicine support care groups from inception until the final of the prenatal care (6 weeks postpartum).
Time Frame: First measure at baseline, last measure at birth time
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).
Time Frame: First measure at baseline, last measure at the end of postpartum period (6 week 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary analysis of anxiety levels between usual care and telemedicine support care groups.
Time Frame: 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)
Mean between-groups differences in General Anxiety Disorder (GAD-7) scale scores.
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
Time Frame: Assesed at birth
Cumulative incidence of gestational diabetes diagnosis; high blood pressure events (pre-eclampsia and eclampsia); severe anemia; need to forward to high-risk prenatal care program; cardiovascular events with or without hospitalization; cardiovascular attributable death during pregnancy and postpartum period; maternal attributable underlying cause of death; all-cause mortality.
Assesed at birth
Fetal and neonatal fatal and non-fatal outcomes
Time Frame: Assesed at birth
Cumulative incidence and mean difference between-groups of: gestational age at birth; birth weight; APGAR score; neonatal intensive care unit (ICU) admission; death by intentional and unintentional abortion; events related to underlying causes of fetal and neonatal periods; fatal events related to underlying causes of fetal and neonatal events
Assesed at birth
Quality of life levels between usual care and telemedicine support care
Time Frame: 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)
Mean between-groups differences in the Portuguese validated EuroQoL 5D scores (EQ-5D).
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Talita Colombo

Collaborators

Hospital de Clinicas de Porto Alegre
McMaster University
VU University of Amsterdam
Irmandade Santa Casa de Misericórdia de Porto Alegre

Investigators

  • Study Chair: Lucas Helal, MSc, PhD, Federal University of Rio Grande do Sul
  • Principal Investigator: Airton T Stein, MD, PhD, Federal University of Health Science of Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Estimate)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48740621.9.0000.5335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We added an individual participant data sharing policy (IPD data-sharing) and tabular results will be displayed in this CT.gov in a 12-month range after our primary completion (PC) at max. Third parties interested to use the m@mae-e data should contact the study chair and the study's PI. IPD will be released in a public and safe repository in a de identified manner. Altogether to the raw data, individuals will have access to case report files, the study protocol, materials, SAP and codes.

IPD Sharing Time Frame

6 months after primary completion date, for at least 10 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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