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

COVID-19 Pandemic Clinical Trial

— m@mae-e  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05745896
• Other study ID #: 48740621.9.0000.5335
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2023
• Source: Federal University of Health Science of Porto Alegre
• Contact: Talita Colombo, MD, MSc
• Phone: +55 51 3024 5657
• Email: talitacolombo[@]ufcspa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Telemedicine appointment
Three online appointments for pregnancy monitoring at prenatal care.
• Face-to-face appointment
Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.

Locations

Country	Name	City	State
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre (ISCMPA)	Porto Alegre	Rio Grande Do Sul

Sponsors (5)

Lead Sponsor	Collaborator
Talita Colombo	Hospital de Clinicas de Porto Alegre, Irmandade Santa Casa de Misericórdia de Porto Alegre, McMaster University, VU University of Amsterdam

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Secondary analysis of anxiety levels between usual care and telemedicine support care groups.	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)
Secondary	Maternal fatal and non-fatal outcomes	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
Secondary	Fetal and neonatal fatal and non-fatal outcomes	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
Secondary	Quality of life levels between usual care and telemedicine support care	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)

External Links

•   Repository for study's management.