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

Not Applicable

Not yet recruiting

• Conditions: Prenatal Stress; COVID-19 Pandemic; Pregnancy; Mental Disorders
• Interventions: Other: Face-to-face appointment; Other: Telemedicine appointment

• Registration Number: NCT05745896
• Lead Sponsor: Talita Colombo

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).

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 Timeline

• Study First Submitted: 2022-07-31
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-23
• Last Update Submitted: 2023-02-23
• Study First Posted: 2023-02-27
• Last Update Posted: 2023-02-27
• Study Start: 2023-07-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Face-to-face appointment	Pregnants at usual care attending appointments in-person.
Telemedicine Prenatal Care	Telemedicine appointment	Pregnants under telemedicine based group attending at least 6 in-person outpatient clinic appointments and the remaining ones (i.e., 3) online.
Telemedicine Prenatal Care	Face-to-face appointment	Pregnants under telemedicine based group attending at least 6 in-person outpatient clinic appointments and the remaining ones (i.e., 3) online.

Primary Outcome Measures

Name	Time	Method
Anxiety levels in usual care and telemedicine support care groups from inception until the final of the prenatal care (6 weeks postpartum).	First measure at baseline, last measure at birth time	Mean between-group differences in General Anxiety Disorder (GAD-7) scale scores.
Anxiety levels in usual care and telemedicine support care groups from inception until the final of the postpartum period (6 weeks postpartum).	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.

Secondary Outcome Measures

Name	Time	Method
Maternal fatal and non-fatal outcomes	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.
Fetal and neonatal fatal and non-fatal outcomes	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
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)	Mean between-groups differences in General Anxiety Disorder (GAD-7) scale scores.
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)	Mean between-groups differences in the Portuguese validated EuroQoL 5D scores (EQ-5D).

Trial Locations

Locations (1)

Irmandade da Santa Casa de Misericórdia de Porto Alegre (ISCMPA); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil