OptiBIRTH : a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section

Clarke, Mike; Devane, Declan; Gross, Mechthild Maria; Morano, Sandra; Lundgren, Ingela; Sinclair, Marlene; Putman, Koen; Beech, Beverley; Vehviläinen-Julkunen, Katri; Nieuwenhuijze, Marianne; Wiseman, Hugh; Smith, Valerie; Daly, Deirdre; Savage, Gerard; Newell, John; Simpkin, Andrew; Grylka, Susanne; Healy, Patricia; Nicoletti, Jane; Lalor, Joan; Carroll, Margaret; van Limbeek, Evelien; Nilsson, Christina; Stockdale, Janine; Fobelets, Maaike; Begley, Cecily

doi:10.1186/s12884-020-2829-y

Please use this identifier to cite or link to this item: https://doi.org/10.21256/zhaw-19826

Publication type:	Article in scientific journal
Type of review:	Open peer review
Title:	OptiBIRTH : a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section
Authors:	Clarke, Mike Devane, Declan Gross, Mechthild Maria Morano, Sandra Lundgren, Ingela Sinclair, Marlene Putman, Koen Beech, Beverley Vehviläinen-Julkunen, Katri Nieuwenhuijze, Marianne Wiseman, Hugh Smith, Valerie Daly, Deirdre Savage, Gerard Newell, John Simpkin, Andrew Grylka, Susanne Healy, Patricia Nicoletti, Jane Lalor, Joan Carroll, Margaret van Limbeek, Evelien Nilsson, Christina Stockdale, Janine Fobelets, Maaike Begley, Cecily
et. al:	No
DOI:	10.1186/s12884-020-2829-y 10.21256/zhaw-19826
Published in:	BMC Pregnancy & Childbirth
Volume(Issue):	20
Issue:	143
Issue Date:	2020
Publisher / Ed. Institution:	BioMed Central
ISSN:	1471-2393
Language:	English
Subject (DDC):	618.4: Childbirth
Abstract:	Background: Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are low in many countries. Methods: OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC rates through an unblinded cluster randomised trial in 15 maternity units with VBAC rates < 35% in Germany, Ireland and Italy. Sites were matched in pairs or triplets based on annual birth numbers and VBAC rate, and randomised, 1:1 or 2:1, intervention versus control, following trial registration. The intervention involved evidence-based education of clinicians and women with one previous caesarean section (CS), appointment of opinion leaders, audit/peer review, and joint discussions by women and clinicians. Control sites provided usual care. Primary outcome was annual hospital-level VBAC rates before the trial (2012) versus final year of the trial (2016). Between April 2014 and October 2015, 2002 women were recruited (intervention 1195, control 807), with mode-of-birth data available for 1940 women. Results: The OptiBIRTH intervention was feasible and safe across hospital settings in three countries. There was no statistically significant difference in the change in the proportion of women having a VBAC between intervention sites (25.6% in 2012 to 25.1% in 2016) and control sites (18.3 to 22.3%) (odds ratio adjusted for differences between intervention and control groups (2012) and for homogeneity in VBAC rates at sites in the countries: 0.87, 95% CI: 0.67, 1.14, p = 0.32 based on 5674 women (2012) and 5284 (2016) with outcome data. Among recruited women with birth data, 4/1147 perinatal deaths > 24 weeks gestation occurred in the intervention group (0.34%) and 4/782 in the control group (0.51%), and two uterine ruptures (one per group), a rate of 1:1000. Conclusions: Changing clinical practice takes time. As elective repeat CS is the most common reason for CS in multiparous women, interventions that are feasible and safe and that have been shown to lead to decreasing repeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. This may best be done using an implementation science approach that can modify evidence-based interventions in response to changing clinical circumstances. Trial registration: The OptiBIRTH trial was registered on 3/4/2013. Trial registration number ISRCTN10612254.
URI:	https://digitalcollection.zhaw.ch/handle/11475/19826
Fulltext version:	Published version
License (according to publishing contract):	CC BY 4.0: Attribution 4.0 International
Departement:	School of Health Sciences
Organisational Unit:	Institute of Midwifery and Reproductive Health (IHG)
Appears in collections:	Publikationen Gesundheit

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Clarke, M., Devane, D., Gross, M. M., Morano, S., Lundgren, I., Sinclair, M., Putman, K., Beech, B., Vehviläinen-Julkunen, K., Nieuwenhuijze, M., Wiseman, H., Smith, V., Daly, D., Savage, G., Newell, J., Simpkin, A., Grylka, S., Healy, P., Nicoletti, J., et al. (2020). OptiBIRTH : a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section. BMC Pregnancy & Childbirth, 20(143). https://doi.org/10.1186/s12884-020-2829-y

Clarke, M. et al. (2020) ‘OptiBIRTH : a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section’, BMC Pregnancy & Childbirth, 20(143). Available at: https://doi.org/10.1186/s12884-020-2829-y.

M. Clarke et al., “OptiBIRTH : a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section,” BMC Pregnancy & Childbirth, vol. 20, no. 143, 2020, doi: 10.1186/s12884-020-2829-y.

CLARKE, Mike, Declan DEVANE, Mechthild Maria GROSS, Sandra MORANO, Ingela LUNDGREN, Marlene SINCLAIR, Koen PUTMAN, Beverley BEECH, Katri VEHVILÄINEN-JULKUNEN, Marianne NIEUWENHUIJZE, Hugh WISEMAN, Valerie SMITH, Deirdre DALY, Gerard SAVAGE, John NEWELL, Andrew SIMPKIN, Susanne GRYLKA, Patricia HEALY, Jane NICOLETTI, Joan LALOR, Margaret CARROLL, Evelien VAN LIMBEEK, Christina NILSSON, Janine STOCKDALE, Maaike FOBELETS und Cecily BEGLEY, 2020. OptiBIRTH : a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section. BMC Pregnancy & Childbirth. 2020. Bd. 20, Nr. 143. DOI 10.1186/s12884-020-2829-y

Clarke, Mike, Declan Devane, Mechthild Maria Gross, Sandra Morano, Ingela Lundgren, Marlene Sinclair, Koen Putman, et al. 2020. “OptiBIRTH : A Cluster Randomised Trial of a Complex Intervention to Increase Vaginal Birth after Caesarean Section.” BMC Pregnancy & Childbirth 20 (143). https://doi.org/10.1186/s12884-020-2829-y.

Clarke, Mike, et al. “OptiBIRTH : A Cluster Randomised Trial of a Complex Intervention to Increase Vaginal Birth after Caesarean Section.” BMC Pregnancy & Childbirth, vol. 20, no. 143, 2020, https://doi.org/10.1186/s12884-020-2829-y.