COVID-19 Pandemic, Pregnancy; Mental Disorders, Prenatal Stress
Conditions
Keywords
prenatal care, covid-19, telemedicine, low risk prenatal line of care, health policy, randomized clinical trial
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).
Interventions
OTHERTelemedicine appointment
Three online appointments for pregnancy monitoring at prenatal care.
Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.
Sponsors
Irmandade Santa Casa de Misericórdia de Porto Alegre
McMaster University
VU University of Amsterdam
Hospital de Clinicas de Porto Alegre
Talita Colombo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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). |
Countries
Brazil
Contacts
Primary ContactTalita Colombo, MD, MSc
Outcome results
None listed