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
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...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-09-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e037175.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1841554016552615936 |
|---|---|
| author | Soo Downe Lisa Askie Sarah J Lord Hannah G Dahlen Kenneth William Finlayson Anna Lene Seidler Federico Girosi Kylie Elizabeth Hunter Kate M Levett Mary-Ann Davey Caroline A Smith Julie Fleet Mary Steen Elizabeth Newnham Anette Werner Leslie Arnott Kerry Sutcliffe |
| author_facet | Soo Downe Lisa Askie Sarah J Lord Hannah G Dahlen Kenneth William Finlayson Anna Lene Seidler Federico Girosi Kylie Elizabeth Hunter Kate M Levett Mary-Ann Davey Caroline A Smith Julie Fleet Mary Steen Elizabeth Newnham Anette Werner Leslie Arnott Kerry Sutcliffe |
| author_sort | Soo Downe |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-208fec742b6e49468220131d770b3c21 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-208fec742b6e49468220131d770b3c212025-01-09T00:05:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-037175The 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-analysisSoo Downe0Lisa Askie1Sarah J Lord2Hannah G Dahlen3Kenneth William Finlayson4Anna Lene Seidler5Federico Girosi6Kylie Elizabeth Hunter7Kate M Levett8Mary-Ann Davey9Caroline A Smith10Julie Fleet11Mary Steen12Elizabeth Newnham13Anette Werner14Leslie Arnott15Kerry Sutcliffe1612 THRIVE Centre, School of Heath and Community Studies, University of Central Lancashire, Preston, UKNHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia14 The School of Medicine, University of Notre Dame Australia - Darlinghurst Campus, Darlinghurst, New South Wales, Australia1 School of Nursing and Midwifery, Western Sydney University, Penrith South, New South Wales, AustraliaSchool of Midwifery and Community Health, University of Central Lancashire, Preston, Lancashire, UKCentre for Research Excellence in the Early Prevention of Obesity in Childhood, University of Sydney, Sydney, New South Wales, AustraliaTranslational Health Research Institute, Western Sydney University, Penrith, New South Wales, AustraliaEvidence Integration, NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, AustraliaNICM Health Research Institute, University of Western Sydney, Penrith South, New South Wales, Australia6 Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, AustraliaNICM Health Research Institute, University of Western Sydney, Penrith South, New South Wales, AustraliaSchool of Nursing and Midwifery, University of South Australia, Adelaide, South Australia, AustraliaSchool of Nursing and Midwifery, University of South Australia, Adelaide, South Australia, AustraliaSchool of Nursing & Midwifery, Griffith University, Medowbrook, Queensland, AustraliaDepartment of Clinical Research, University of Southern Denmark, Odense, DenmarkThe B.E.A.R. Program, Lamaze Australia, Melbourne, Victoria, AustraliaSchool of Medicine Sydney, University of Notre Dame Australia, Darlinghurst, New South Wales, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/10/9/e037175.full |
| spellingShingle | Soo Downe Lisa Askie Sarah J Lord Hannah G Dahlen Kenneth William Finlayson Anna Lene Seidler Federico Girosi Kylie Elizabeth Hunter Kate M Levett Mary-Ann Davey Caroline A Smith Julie Fleet Mary Steen Elizabeth Newnham Anette Werner Leslie Arnott Kerry Sutcliffe 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/9/e037175.full |
| work_keys_str_mv | AT soodowne theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT lisaaskie theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT sarahjlord theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT hannahgdahlen theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT kennethwilliamfinlayson theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT annaleneseidler theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT federicogirosi theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT kylieelizabethhunter theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT katemlevett theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT maryanndavey theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT carolineasmith theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT juliefleet theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT marysteen theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT elizabethnewnham theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT anettewerner theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT lesliearnott theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT kerrysutcliffe theaeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT soodowne aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT lisaaskie aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT sarahjlord aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT hannahgdahlen aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT kennethwilliamfinlayson aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT annaleneseidler aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT federicogirosi aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT kylieelizabethhunter aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT katemlevett aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT maryanndavey aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT carolineasmith aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT juliefleet aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT marysteen aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT elizabethnewnham aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT anettewerner aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT lesliearnott aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis AT kerrysutcliffe aeducatecollaborationcomprehensiveantenataleducationbirthpreparationprogrammestoreducetheratesofcaesareansectioninnulliparouswomenprotocolforanindividualparticipantdataprospectivemetaanalysis |