title: Improving the organisation of maternal health service delivery and optimising childbirth by increasing vaginal birth after caesarean section through enhanced women-centred care (OptiBIRTH trial): study protocol for a randomised controlled trial (ISRCTN10612254).
abstract: BACKGROUND
  The proportion of pregnant women who have a caesarean section shows a wide variation across Europe, and concern exists that these proportions are increasing. Much of the increase in caesarean sections in recent years is due to a cascade effect in which a woman who has had one caesarean section is much more likely to have one again if she has another baby. In some places, it has become common practice for a woman who has had a caesarean section to have this procedure again as a matter of routine. The alternative, vaginal birth after caesarean (VBAC), which has been widely recommended, results in fewer undesired results or complications and is the preferred option for most women. However, VBAC rates in some countries are much lower than in other countries.
  
  
  METHODS
  The OptiBIRTH trial uses a cluster randomised design to test a specially developed approach to try to improve the VBAC rate. It will attempt to increase VBAC rates from 25 % to 40 % through increased women-centred care and women's involvement in their care. Sixteen hospitals in Germany, Ireland and Italy agreed to join the study, and each hospital was randomly allocated to be either an intervention or a control site.
  
  
  CONCLUSIONS
  If the OptiBIRTH intervention succeeds in increasing VBAC rates, its application across Europe might avoid the 160,000 unnecessary caesarean sections that occur every year at an extra direct annual cost of more than €150 million.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN10612254 , registered 3 April 2013.
authors.affiliation: Northern Ireland Network for Trials Methodology Research, Centre for Public Health, Institute of Clinical Sciences B, Queen's University Belfast, Royal Hospitals, Grosvenor Road, Belfast, BT12 6BJ, UK. m.clarke@qub.ac.uk.
authors.forename: Mike
authors.initials: M
authors.lastname: Clarke
authors.affiliation: Centre for Public Health, Queen's University Belfast, Belfast, UK. g.savage@qub.ac.uk.
authors.forename: Gerard
authors.initials: G
authors.lastname: Savage
authors.affiliation: School of Nursing and Midwifery, NUI Galway, Galway, Ireland. SMITHV1@tcd.ie.|School of Nursing and Midwifery, Trinity College Dublin, Dublin, Ireland. SMITHV1@tcd.ie.
authors.forename: Valerie
authors.initials: V
authors.lastname: Smith
authors.affiliation: School of Nursing and Midwifery, Trinity College Dublin, Dublin, Ireland. dalyd8@tcd.ie.
authors.forename: Deirdre
authors.initials: D
authors.lastname: Daly
authors.affiliation: School of Nursing and Midwifery, NUI Galway, Galway, Ireland. declan.devane@nuigalway.ie.
authors.forename: Declan
authors.initials: D
authors.lastname: Devane
authors.affiliation: Midwifery Research and Education Unit, Hannover Medical School, Hannover, Germany. Gross.Mechthild@mh-hannover.de.
authors.forename: Mechthild M
authors.initials: MM
authors.lastname: Gross
authors.affiliation: Midwifery Research and Education Unit, Hannover Medical School, Hannover, Germany. Grylka-Baeschlin.Susanne@mh-hannover.de.
authors.forename: Susanne
authors.initials: S
authors.lastname: Grylka-Baeschlin
authors.affiliation: School of Nursing and Midwifery, NUI Galway, Galway, Ireland. patricia.healy@nuigalway.ie.
authors.forename: Patricia
authors.initials: P
authors.lastname: Healy
authors.affiliation: Medical School and Midwifery School, Genoa University, Genoa, Italy. sandra.morano@hsanmartino.it.
authors.forename: Sandra
authors.initials: S
authors.lastname: Morano
authors.affiliation: Medical School and Midwifery School, Genoa University, Genoa, Italy. jnicoletti@libero.it.
authors.forename: Jane
authors.initials: J
authors.lastname: Nicoletti
authors.affiliation: School of Nursing and Midwifery, Trinity College Dublin, Dublin, Ireland. cbegley@tcd.ie.
authors.forename: Cecily
authors.initials: C
authors.lastname: Begley
mesh_terms: D002985:Clinical Protocols; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D003695:Delivery of Health Care / Q000191:economics; D005060:Europe; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008427:Maternal Health Services / Q000191:economics; D018579:Patient Selection; D018802:Patient-Centered Care / Q000191:economics; D011247:Pregnancy; D011446:Prospective Studies; D012107:Research Design; D016896:Treatment Outcome; D016064:Vaginal Birth after Cesarean / Q000009:adverse effects / Q000191:economics