Collaborative maternity and newborn dashboard (CoMaND) for the COVID-19 pandemic: a protocol for timely, adaptive monitoring of perinatal outcomes in Melbourne, Australia
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Abstract
The COVID-19 pandemic has resulted in a range of unprecedented disruptions to maternity care with documented impacts on perinatal outcomes such as stillbirth and preterm birth. Metropolitan Melbourne has endured one of the longest and most stringent lockdowns in globally. This paper presents the protocol for a multicentre study to monitor perinatal outcomes in Melbourne, Australia, during the COVID-19 pandemic.
Methods
Multicentre observational study analysing monthly deidentified maternal and newborn outcomes from births > 20 weeks at all 12 public maternity services in Melbourne. Data will be merged centrally to analyse outcomes and create run charts according to established methods for detecting non-random ‘signals’ in healthcare. Perinatal outcomes will include weekly rates of total births, stillbirths, preterm births, neonatal intensive care admissions, low Apgar scores and fetal growth restriction. Maternal outcomes will include weekly rates of: induced labour, caesarean section, births before arrival to hospital, postpartum haemorrhage, length of stay, general anaesthesia for caesarean birth, influenza and COVID-19 vaccination status, and gestation at first antenatal visit. A prepandemic median for all outcomes will be calculated for the period of January 2018 to March 2020. A significant shift is defined as ≥6 consecutive weeks, all above or below the prepandemic median. Additional statistical analyses such as regression, time series and survival analyses will be performed for an in-depth examination of maternal and perinatal outcomes of interests.
Ethics and dissemination
Ethics approval for the collaborative maternity and newborn dashboard project has been obtained from the Austin Health (HREC/64722/Austin-2020) and Mercy Health (ref. 2020-031).
Trial registration number
ACTRN12620000878976; Pre-results.
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SciScore for 10.1101/2021.07.22.21261008: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Field Sample Permit: Authorised representatives of the sponsoring institution as well as representatives from the human research ethics committees, research governance office and regulatory agencies may inspect all documents and records required to be maintained by the CPI in this study.
IRB: Authorised representatives of the sponsoring institution as well as representatives from the human research ethics committees, research governance office and regulatory agencies may inspect all documents and records required to be maintained by the CPI in this study.
Consent: Local site study documents will be stored for at least 15 years and will not be destroyed without the written consent of the CPI.S… SciScore for 10.1101/2021.07.22.21261008: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Field Sample Permit: Authorised representatives of the sponsoring institution as well as representatives from the human research ethics committees, research governance office and regulatory agencies may inspect all documents and records required to be maintained by the CPI in this study.
IRB: Authorised representatives of the sponsoring institution as well as representatives from the human research ethics committees, research governance office and regulatory agencies may inspect all documents and records required to be maintained by the CPI in this study.
Consent: Local site study documents will be stored for at least 15 years and will not be destroyed without the written consent of the CPI.Sex as a biological variable Level 4 centres provide local care for low-risk mothers and babies including births from 34 weeks’ gestation. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Study data will be collected and managed using REDCap electronic data capture tools [12] hosted at The University of Melbourne. REDCapsuggested: (REDCap, RRID:SCR_003445)Deidentified individual patient-level data on ≤ 100 fields will be analysed in STATA SE v16 [13]. STATAsuggested: (Stata, RRID:SCR_012763)Results from OddPub: Thank you for sharing your data.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:However, there are limitations to the data collection methods, including missing data on planned home births, private hospital births, and COVID-19 infection rates in pregnancy. There are also hospital-specific variations to the many data collection fields, requiring manual recoding and collation before indicators can be generated. There are potential risks related to data security. However, as no personally-identifying information will be collected in this study, there is no possibility of breaches of privacy or confidentiality. The risks to the successful conduct of the study include inadequate health service resources to collect and submit the data or insufficient study resources to clean and analyse data on a continuous basis. We have designed this study to leverage existing routine data reporting tools to minimise the burden on health services. We have also obtained philanthropic and University funding to support the central data management and report generation (see Funding declarations).
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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