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

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Levett, Kate M
Lord, Sarah J
Dahlen, Hannah G
Smith, Caroline A
Girosi, Federico
Downe, Soo
Finlayson, Kenneth William
Fleet, Julie
Steen, Mary
Davey, Mary-Ann
Newnham, Elizabeth
Werner, Anette
Arnott, Leslie
Sutcliffe, Kerry
Seidler, Anna Lene
Hunter, Kylie Elizabeth
Askie, Lisa
Griffith University Author(s)
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2020
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http://creativecommons.org/licenses/by-nc/4.0/
Abstract

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.

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BMJ Open
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10
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9
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© 2020 The Authors. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial.
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Clinical sciences
Health services and systems
Public health
Other health sciences
antenatal education
complementary medicine
maternal medicine
obstetrics
pain management
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Levett, KM; Lord, SJ; Dahlen, HG; Smith, CA; Girosi, F; Downe, S; Finlayson, KW; Fleet, J; Steen, M; Davey, M-A; Newnham, E; Werner, A; Arnott, L; Sutcliffe, K; Seidler, AL; Hunter, KE; Askie, L, 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., BMJ Open, 2020, 10 (9)
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