Clinical trial NCT05745896: A Telemedicine Prenatal Care Model on Low Risk Pregnants: The m@Mae-e Study
Official title: A Telemedicine Prenatal Care Model on Low Risk Pregnants: An Effectiveness Randomized Clinical Trial (The m@Mae-e Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Irmandade Santa Casa de Misericórdia de Porto Alegre
name: McMaster University
name: VU University of Amsterdam
name: Hospital de Clinicas de Porto Alegre
First posted: 2023-02-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety levels in usual care and telemedicine support care groups from inception until the final of the prenatal care (6 weeks postpartum).
timeFrame: First measure at baseline, last measure at birth time
measure: Anxiety levels in usual care and telemedicine support care groups from inception until the final of the postpartum period (6 weeks postpartum).
timeFrame: First measure at baseline, last measure at the end of postpartum period (6 week postpartum).
Secondary outcomes:
measure: Secondary analysis of anxiety levels between usual care and telemedicine support care groups.
timeFrame: 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)
measure: Maternal fatal and non-fatal outcomes
timeFrame: Assesed at birth
measure: Fetal and neonatal fatal and non-fatal outcomes
timeFrame: Assesed at birth
measure: Quality of life levels between usual care and telemedicine support care
timeFrame: 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)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre (ISCMPA)
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Lucas Helal, MSc, PhD
role: STUDY_CHAIR
affiliation: Federal University of Health Science of Porto Alegre
name: Airton T Stein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.