Communication Intervention Using Digital Technology to Facilitate Informed Choices at Childbirth in the Context of the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial
Authors: Diniz Carmen Simone Grilo , Franzon Ana Carolina Arruda , Fioretti-Foschi Beatriz , Niy Denise Yoshie , Pedrilio Livia Sanches , Amaro Jr Edson , Sato João Ricardo 
Published: February 2021

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