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The AEDUCATE Collaboration. Comprehensive antenatal education birth preparation programmes to reduce the rates of caesarean section in nulliparous women. Protocol for an individual participant data prospective meta-analysis

journal contribution
posted on 12.11.2020, 00:38 by KM Levett, SJ Lord, HG Dahlen, CA Smith, F Girosi, S Downe, KW Finlayson, J Fleet, M Steen, Mary-Ann Davey, E Newnham, A Werner, L Arnott, K Sutcliffe, AL Seidler, KE Hunter, L Askie
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. INTRODUCTION: Rates of medical interventions in normal labour and birth are increasing. This prospective meta-analysis (PMA) proposes to assess whether the addition of a comprehensive multicomponent birth preparation programme reduces caesarean section (CS) in nulliparous women compared with standard hospital care. Additionally, do participant characteristics, intervention components or hospital characteristics modify the effectiveness of the programme? METHODS AND ANALYSIS: Population: women with singleton vertex pregnancies, no planned caesarean section (CS) or epidural.Intervention: in addition to hospital-based standard care, a comprehensive antenatal education programme that includes multiple components for birth preparation, addressing the three objectives: preparing women and their birth partner/support person for childbirth through education on physiological/hormonal birth (knowledge and understanding); building women's confidence through psychological preparation (positive mindset) and support their ability to birth without pain relief using evidence-based tools (tools and techniques). The intervention could occur in a hospital-based or community setting.Comparator: standard care alone in hospital-based maternity units. OUTCOMES: Primary: CS.Secondary: epidural analgesia, mode of birth, perineal trauma, postpartum haemorrhage, newborn resuscitation, psychosocial well-being.Subgroup analysis: parity, model of care, maternal risk status, maternal education, maternal socio-economic status, intervention components. STUDY DESIGN: An individual participant data (IPD) prospective meta-analysis (PMA) of randomised controlled trials, including cluster design. Each trial is conducted independently but share core protocol elements to contribute data to the PMA. Participating trials are deemed eligible for the PMA if their results are not yet known outside their Data Monitoring Committees. ETHICS AND DISSEMINATION: Participants in the individual trials will consent to participation, with respective trials receiving ethical approval by their local Human Research Ethics Committees. Individual datasets remain the property of trialists, and can be published prior to the publication of final PMA results. The overall data for meta-analysis will be held, analysed and published by the collaborative group, led by the Cochrane PMA group. TRIAL REGISTRATION NUMBER: CRD42020103857.

Funding

This study was supported by NHMRC (GNT1166247).

NHMRC | GNT1166247

History

Publication Date

23/09/2020

Journal

BMJ Open

Volume

10

Issue

9

Article Number

e037175

Pagination

11p.

Publisher

BMJ

ISSN

2044-6055

Rights Statement

The Author reserves all moral rights over the deposited text and must be credited if any re-use occurs. Documents deposited in OPAL are the Open Access versions of outputs published elsewhere. Changes resulting from the publishing process may therefore not be reflected in this document. The final published version may be obtained via the publisher’s DOI. Please note that additional copyright and access restrictions may apply to the published version.

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