AGRADECIMENTOS À Deus, pelas oportunidades e por me amparar nos momentos difíceis, mostrando-me o caminho nas horas incertas. À minha orientadora Profa. Dra. Adriana Inocenti Miasso, pela paciência que teve comigo, pelos ensinamentos e pelas horas de leituras gastas no meu trabalho, por acreditar no futuro deste projeto e contribuir para o meu crescimento profissional e por ser também um exemplo a ser seguido. Meu eterno agradecimento. A minha mãe Liamara, a quem me deu a vida e me dá amparo, e por cada tijolinho moldado com sua experiência, que me foi dado com tanto amor para construir minha própria estrada. TE AMO. Aos meus irmãos, João Guilherme e Ana Vitória, pela paciência e tolerância durante essa jornada! A minha querida família, meus "parentes", que sempre me apoiaram e incentivaram com palavras de apoio e carinho, em especial, minha avó Ana e meu avô Guilherme, onde agradeço em orações, por terem sido essenciais na minha vida, mesmo tendo partido antes de eu poder dizer te amo.
BACKGROUND In Brazil, and in other low-and-middle-income countries, the excess of interventions in childbirth has been associated with an increase in preterm and early term births, contributing to stagnant morbidity and mortality of mothers and babies. The fact that women often report a negative experience in vaginal childbirth, with physical pain and feelings of unsafety, neglect or abuse, may explain the high acceptability of elective cesarean sections. The recognition of the information needs and of the right to informed choice in childbirth can contribute to change this reality. The internet has been the main source of health information, but its quality is highly variable. OBJECTIVE Develop and evaluate an information/communication strategy through a smartphone application about childbirth, to facilitate informed choice for access to safer and evidence-based care, in the context of the Covid-19 pandemic. METHODS Randomized-controlled trial, with two arms (intervention and control), blind, parallel, to be conducted in a smartphone application, with women in reproductive age. After completing an entry questionnaire to verify the eligibility criteria and ethical consent, around 20,000 participants will be randomly allocated between the intervention and control groups in a 1: 1 ratio. Participants allocated to the intervention group will be invited to engage in an online information and communication strategy, designed to expand evidence-based knowledge on the advantages and disadvantages of options in labor and birth, and safety of care processes. The information is based on the guidelines of the Ministry of Health and the World Health Organization for a positive childbirth experience, and are updated to include the new challenges and disruptions in maternity care within the Covid-19 pandemic. The control group will receive information about disposable and reusable diapers as placebo intervention. The groups will be compared in their responses on a mission to prepare the birth plan, as well as in the entry and exit questionnaires, regarding answers less or more aligned with the guidelines for a positive childbirth experience. A qualitative component to map information needs is included. RESULTS The digital trial will start recruiting participants in late October 2020 and data collection is projected to finish by December 2020. CONCLUSIONS This study will evaluate an innovative intervention that has the potential to promote better communication between women and providers, so that they can make better choices and ensure their rights during the pandemic. CLINICALTRIAL Brazilian Registry of Clinical Trials – ReBEC (http://www.ensaiosclinicos.gov.br/rg/RBR-3g5f9f/). WHO’s Unique Trial Number (UTN U1111-1255-8683). This is the first version of the trial protocol.
Background In Brazil and other low- and middle-income countries, excess interventions in childbirth are associated with an increase in preterm and early-term births, contributing to stagnant morbidity and mortality of mothers and neonates. The fact that women often report a negative experience with vaginal childbirth, with physical pain and feelings of unsafety, neglect, or abuse, may explain the high acceptability of elective cesarean sections. The recognition of information needs and of the right to informed choice during childbirth can help change this reality. The internet has been the main source of health information, but its quality is highly variable. Objective This study aimed to develop and evaluate an information and communication strategy through a smartphone app with respect to childbirth, to facilitate informed choices for access to safer and evidence-based care in the context of the COVID-19 pandemic. Methods A randomized controlled trial, with 2 arms (intervention and control) and a closed, blind, parallel design, will be conducted with a smartphone app designed for behavior and opinion research in Brazil, with women of reproductive age previously registered on the app. After completing an entry questionnaire to verify the eligibility criteria and obtaining ethical consent, approximately 20,000 participants will be randomly allocated to the intervention and control groups at a 1:1 ratio. Participants allocated to the intervention group will be invited to engage in a digital information and communication strategy, which is designed to expand evidence-based knowledge on the advantages and disadvantages of options for labor and childbirth and the safety of the care processes. The information is based on the guidelines of the Ministry of Health and the World Health Organization for a positive childbirth experience and has been updated to include the new challenges and disruptions in maternity care within the context of the COVID-19 pandemic. The control group will receive information regarding disposable and reusable diapers as a placebo intervention. The groups will be compared in their responses in generating the birth plan and the entry and exit questionnaires, regarding responses less or more aligned with the guidelines for a positive childbirth experience. A qualitative component to map information needs is included. Results The digital trial started recruiting participants in late October 2020, and data collection has been projected to be complete by December 2020. Conclusions This study will evaluate an innovative intervention that has the potential to promote better communication between women and providers, such that they can make better choices using an approach suitable for use during the COVID-19 pandemic. Trial Registration The Brazilian Clinical Trials Registry U1111-1255-8683; http://www.ensaiosclinicos.gov.br/rg/RBR-3g5f9f/ International Registered Report Identifier (IRRID) PRR1-10.2196/25016
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