Pregnancy; Mental Disordersm@mae-eNCT05745896
A Telemedicine Prenatal Care Model on Low Risk Pregnants: The m@Mae-e Study
A study testing Telemedicine appointment and Face-to-face appointment in people with Pregnancy; Mental Disorders and COVID-19 Pandemic, run by Talita Colombo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy; Mental Disorders, COVID-19 Pandemic, Prenatal Stress
- What is being tested?
- Telemedicine appointment and Face-to-face appointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade da Santa Casa de Misericórdia de Porto Alegre (ISCMPA)
Porto Alegre, Rio Grande do Sul, 90020-090
About this study
Official title: 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).
Read the 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).
- Being tested
- Telemedicine appointment, Face-to-face appointment
- Keywords
- prenatal care, covid-19, telemedicine, low risk prenatal line of care, health policy, randomized clinical trial
- Medical subject headings
- Mental Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine appointmentOther
Three online appointments for pregnancy monitoring at prenatal care.
Face-to-face appointmentOther
Six to nine face-to-face appointments for pregnancy monitoring at prenatal care.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Pregnants at usual care attending appointments in-person. Receives: Other: Face-to-face appointment |
| Telemedicine Prenatal Care | Experimental | Pregnants under telemedicine based group attending at least 6 in-person outpatient clinic appointments and the remaining ones (i.e., 3) online. Receives: Other: Telemedicine appointment; Other: Face-to-face appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Mean between-group differences in General Anxiety Disorder (GAD-7) scale scores.
Measured: First measure at baseline, last measure at the end of postpartum period (6 week postpartum).
Secondary outcomes (4)
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.
Measured: 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
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.
Measured: Assesed at birth
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
Measured: Assesed at birth
Quality of life levels between usual care and telemedicine support care
Mean between-groups differences in the Portuguese validated EuroQoL 5D scores (EQ-5D).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy; Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Talita Colombo
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre, McMaster University, VU University of Amsterdam, Hospital de Clinicas de Porto Alegre
- Responsible party
- Sponsor-investigator, Talita Colombo, Federal University of Health Science of Porto Alegre
- Investigators
- Lucas Helal, MSc, PhD, Study chair, Federal University of Rio Grande do SulAirton T Stein, MD, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745896
- Sponsor's protocol ID
- 48740621.9.0000.5335
- Acronym
- m@mae-e
- Status last verified
- Feb 2023
- First submitted
- 31 Jul 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35853473Stein 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.
PubMed 35623804
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telemedicine Prenatal Care Model on Low Risk Pregnants: An Effectiveness Randomized Clinical Trial (The m@Mae-e Study)
- ClinicalTrials.gov ID
- NCT05745896
- Acronym / sponsor ID
- m@mae-e / 48740621.9.0000.5335
- Keywords
- prenatal care, covid-19, telemedicine, low risk prenatal line of care, health policy, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Talita ColomboUniversity, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre, McMaster University, VU University of Amsterdam, Hospital de Clinicas de Porto Alegre
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Face-to-face appointmentPregnants at usual care attending appointments in-person. |
| Telemedicine Prenatal Care | Experimental | Other: Telemedicine appointment, Other: Face-to-face appointmentPregnants under telemedicine based group attending at least 6 in-person outpatient clinic appointments and the remaining ones (i.e., 3) online. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine appointmentThree online appointments for pregnancy monitoring at prenatal care. | Other | Telemedicine Prenatal Care |
| Face-to-face appointmentSix to nine face-to-face appointments for pregnancy monitoring at prenatal care. | Other | Telemedicine Prenatal Care, Usual Care |
Primary outcome
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.
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.
4 secondary outcomes
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)
Maternal fatal and non-fatal outcomes
Time frame: Assesed at birth
Fetal and neonatal fatal and non-fatal outcomes
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 35853473Colombo 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.
- Background: PubMed 35623804Stein 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.
- Repository for study's management.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Helal, MSc, PhD study chair
Federal University of Rio Grande do Sul
Airton T Stein, MD, PhD principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine appointment and Face-to-face appointment in people with Pregnancy; Mental Disorders and COVID-19 Pandemic, run by Talita Colombo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Talita Colombo, MD, MSc (+55 51 3024 5657, talitacolombo@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745896, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.