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Ayla App: Socio-environmental Models that lead to Maternal, Fetal, Neonatal and Infant Consequences

Ayla App: Social and Environmental Models influencing Maternal, Fetal, Neonatal and Children´s Outcomes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10h8j7q7
Enrollment
Unknown
Registered
2023-05-30
Start date
2023-03-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Care

Interventions

A randomized controlled clinical trial, with 4 arms. A total of 4000 participants will be included in this research. Each onde of them will be randomized and may be included in one of the 4 groups (ar
H02.403.840

Sponsors

Universidade da Região de Joinville
Lead Sponsor
Secretaria Estadual de Saúde
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 34 Years

Inclusion criteria

Inclusion criteria: Primiparous pregnant women without previous comorbidities defined at the time of randomization; Literate in the language Portuguese; Aged 18 to 34 years old or older; With gestational age up to 13 weeks considering the date of the last menstruation; Which have the date of the last menstruation defined; Who have planned the birth at Maternidade Darcy Vargas (MDV); Who have a mobile device compatible with the Ayla app and who voluntarily accept to participate in the research by reading and assent of the TCLE being informed the free will to stop participating in the research at any time time

Exclusion criteria

Exclusion criteria: Definition of gestational age outside the 1st trimester after performing obstetric ultrasonography (USG); Multiple pregnancy identified later; Abortion during the research; Delivery in a different place other than the Maternity Darcy Vargas; Withdrawal after signing the consent form; Loss of segment of the pregnant woman due to abandonment of follow-up and inability to contact by telephone (including loss or change of telephone number or cell phone)

Design outcomes

Primary

MeasureTime frame
Better neuropsychomotor development outcomes are expected among babies in which pregnant women were guided and monitored by the application;A lower number of gagging is expected among babies whose mothers had access to the application's information;A lower occurrence of cesareans is expected among participants in the intervention group compared to the control group;It is expected to find a greater number of prenatal consultations among pregnant women in the intervention group compared to the control group ;It is expected to find an adequate nutritional status of breastfed babies and with adequate food introduction in the intervention group when compared to the control group;An increase in adherence to regular physical activity is expected by participants in the intervention group when compared to the control group;A greater return to postpartum physical activity is expected by the participants of the group intervention compared to the control group;A higher rate of participants with adequate weight gain is expected in the intervention group when compared to the control group;A smaller number of participants with postpartum weight retention after 24 months are expected in the intervention group when compared to the control group;A lower chance of developing DMG and DHEG is expected in participants in the intervention group when compared to the control group;A higher rate of adherence to exclusive breastfeeding (breastfeeding) is expected up to the 6th month of life of the baby (NB) and to breastfeeding up to 24 months of age in the intervention group when compared to the control group;It is expected to find a higher rate of performance of tests recommended in prenatal care by the Basic Care Notebook n. 32 – Attention to low-risk prenatal care (Programa de Humanization of Labor and Birth) among pregnant women in the intervention group in comparison to control group;It is expected to find a better assessment of the quality of prenatal care according to the analysis of

Secondary

MeasureTime frame
No secondary outcomes expected

Countries

Brazil

Contacts

Public ContactCarla Hoffmann

Carla Beatriz Pimentel Cesar Hoffmann

carlabeatrizhoffmann@gmail.com+554734615500

Outcome results

None listed

Source: REBEC (via WHO ICTRP)