Carmen Simone Grilo Diniz
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Ana Carolina Arruda Franzon
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Beatriz Fioretti-Foschi
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Denise Yoshie Niy
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Livia Pedrilio
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...
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.
A Randomized Controlled Trial of Attentional Control Training for Treating Alcohol Use Disorder
