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Obstetrics and gynaecology
Protocol
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
  1. Kate M Levett1,2,
  2. Sarah J Lord1,3,
  3. Hannah G Dahlen4,
  4. Caroline A Smith2,5,
  5. Federico Girosi6,7,
  6. Soo Downe8,
  7. Kenneth William Finlayson8,
  8. Julie Fleet9,
  9. Mary Steen9,
  10. Mary-Ann Davey10,
  11. Elizabeth Newnham11,
  12. Anette Werner12,
  13. Leslie Arnott13,
  14. Kerry Sutcliffe1,
  15. Anna Lene Seidler14,
  16. Kylie Elizabeth Hunter14,
  17. Lisa Askie14
  1. 1School of Medicine Sydney, University of Notre Dame Australia, Darlinghurst, New South Wales, Australia
  2. 2NICM Health Research Institute, University of Western Sydney, Penrith South, New South Wales, Australia
  3. 3NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia
  4. 4School of Nursing and Midwifery, University of Western Sydney, Parramatta, New South Wales, Australia
  5. 5Graduate Research School, University of Western Sydney, Kingswood, New South Wales, Australia
  6. 6Translational Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia
  7. 7Capital Markets CRC, New South Wales, Australia, Sydney, New South Wales, Australia
  8. 8School of Midwifery and Community Health, University of Central Lancashire, Preston, Lancashire, UK
  9. 9School of Nursing and Midwifery, University of South Australia, Adelaide, South Australia, Australia
  10. 10Obstetrics & Gynaecology, Monash Health, Monash University Central Clinical School, Melbourne, Victoria, Australia
  11. 11School of Nursing & Midwifery, Griffith University, Medowbrook, Queensland, Australia
  12. 12Department of Clinical Research, University of Southern Denmark, Odense, Denmark
  13. 13The B.E.A.R. Program, Lamaze Australia, Melbourne, Victoria, Australia
  14. 14NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia
  1. Correspondence to Dr Kate M Levett; kate.levett{at}nd.edu.au

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.

Trial registration number CRD42020103857.

  • complementary medicine
  • obstetrics
  • maternal medicine
  • pain management
  • antenatal education
http://creativecommons.org/licenses/by-nc/4.0/

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. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2020-037175

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    Footnotes

    • Twitter @LevettKate, @hannahdahlen, @DrJulieFleet, @LeneSeidler

    • Contributors The protocol was drafted by KML, SJL with significant review and editing review by M-AD, HGD, SD, JF, KWF. Review of methods, analysis and overview of manuscript by LAs, ALS, KEH. Economic analysis advice by FG and reviewed and edited by LAr, LN, CAS, MS, KS, AW. All members of this group were sent draft versions and invited to comment and contribute changes. All authors read and approved the final manuscript. KML guarantees this review.

    • Funding This study was supported by NHMRC (GNT1166247).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement No data are available.

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    © 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. http://creativecommons.org/licenses/by-nc/4.0/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. See: http://creativecommons.org/licenses/by-nc/4.0/.