| 1. |
- Begley, Cecily, 1954, et al.
(författare)
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Evaluation of an intervention to increase vaginal birth after caesarean section through enhanced women-centred care: The OptiBIRTH randomised trial (ISRCTN10612254)
- 2017
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Ingår i: 31th ICM Triennial Congress.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Background: Vaginal birth after a previous caesarean (VBAC) is a safe alternative to repeat caesarean section (CS), is the preferred option of most women and may reduce overall CS rates.1 However, VBAC rates vary; e.g., rates in Germany, Ireland and Italy are considerably lower (29-36%) than those in the Netherlands, Sweden and Finland (45-55%). Purpose/Objective: To evaluate the effectiveness of an intervention to maximise VBAC rates. The OptiBIRTH Project was funded by a European Union Grant: FP7-HEALTH-2012-INNOVATION-1-HEALTH.2012.3.2-1. Agreement No:305208 Method: A cluster randomised trial was used. A sample size of 12 maternity units was required, each recruiting 120 consenting women, to detect an absolute 15% difference in successful VBACs (increase from 25% in control to 40% in intervention groups), using an ICC of 0.05, with power of >80% and an alpha of 0.05. To allow for loss to follow-up, 15 trial units were randomised across three countries with low VBAC rates (Germany, Ireland and Italy) and the trial commenced April 2014. An evidence-based intervention was introduced in all intervention sites. Control sites had usual care. Interim analysis by an independent Data Monitoring Committee at mid-point permitted continuation. Data were analysed using intention to treat. Key Findings: Recruitment closed October 2015, with the last babies born in December 2015, and data analysis will be completed in April 2016. The primary outcome, comparison of annual VBAC rates for each hospital before and after introduction of the intervention will be presented, and selected secondary outcomes for the recruited women including: mode of birth, perineal trauma, breastfeeding, uterine rupture, wound breakdown, perinatal mortality, Apgar scores, and admission to neonatal intensive care unit. Discussion: If the OptiBIRTH intervention increases VBAC rates safely, its introduction across Europe could prevent 160,000 unnecessary CSs every year, saving maternity services >€150 million annually and contributing to the normalisation of birth for thousands of women. References: 1 Cunningham et al (2010). National Institute of Health Consensus Development Conference Statement: Vaginal birth after caesarean. Obstet & Gynecol 115(6): 1279-1295. 2 EURO-PERISTAT 2008: CD006066.EURO-PERISTAT Project (2008). European Perinatal Health Report. (www.europeristat.com).
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| 2. |
- Clarke, Mike, et al.
(författare)
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OptiBIRTH: a cluster randomised trial of acomplex intervention to increase vaginalbirth after caesarean section
- 2020
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Ingår i: BMC Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393 .- 1471-2393.
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Tidskriftsartikel (refereegranskat)abstract
- Background: Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are lowin many countries.Methods: OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC ratesthrough an unblinded cluster randomised trial in 15 maternity units with VBAC rates < 35% in Germany, Ireland andItaly. 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 ofclinicians 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 annualhospital-level VBAC rates before the trial (2012) versus final year of the trial (2016). Between April 2014 and October2015, 2002 women were recruited (intervention 1195, control 807), with mode-of-birth data available for 1940women.Results: The OptiBIRTH intervention was feasible and safe across hospital settings in three countries. There was nostatistically significant difference in the change in the proportion of women having a VBAC between interventionsites (25.6% in 2012 to 25.1% in 2016) and control sites (18.3 to 22.3%) (odds ratio adjusted for differences betweenintervention 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 womenwith birth data, 4/1147 perinatal deaths > 24 weeks gestation occurred in the intervention group (0.34%) and 4/782in 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 inmultiparous women, interventions that are feasible and safe and that have been shown to lead to decreasingrepeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. Thismay best be done using an implementation science approach that can modify evidence-based interventions inresponse to changing clinical circumstances.Trial registration: The OptiBIRTH trial was registered on 3/4/2013. Trial registration number ISRCTN10612254.
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| 3. |
- Sinclair, Marlene, et al.
(författare)
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Assisting women in autonomous decision making about vaginal birth after C section (VBAC): Designing motivational Apps in OptiBIRTH cluster randomised trial (ISRCTN10612254
- 2017
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Ingår i: 31th ICM Triennial Congress 18-22 June 2017.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Background: Optibirth is a funded FP7 research programme using a cluster randomised trial in Ireland, Germany and Italy, with 15 clusters of 94 women per cluster. The aim of OptiBIRTH is to evaluate the effectiveness of a complex intervention aimed at increased VBAC rates through enhanced women-centred care1 .The intervention consisted of motivationally enhanced, evidence-based, educational information for women and clinicians for use in face to face and online modes. Purpose/Objective: This paper reports the design process associated with creating three interrelated mobile apps, as part of a complex intervention, to enable women with a previous caesarean section to decide autonomously between a repeat caesarean section and a vaginal birth. The emphasis has been on using technology creatively and effectively maximizing optimality bearing in mind the needs of the new “Z” generation. Method: Focus groups were undertaken across six European countries to illicit women’s need for information about caesarean section and VBAC. Motivational theory underpinned the development of subsequent e-learning materials to enhance woman-led-decision-making. Ethical approval was obtained from Trinity College University, Dublin. Following analysis of focus group data, consultation with experts and exploration of technological solutions, three electronic applications were designed. Following three iterations, the Apps were reviewed for content, motivational design and functionality by Irish, German and Italian midwifery experts and translated into German and Italian. Key Findings: The following interrelated Apps were designed to provide women and health professionals with rapid access to women’s perceptions of their previous birth experience and their current decision-making-in-progress: “My birth story” uses a wordle to communicate past birth experience “My birth thoughts” enables women to communicate their current decision making “My Birth plan” generates a personalised birth plan Discussion: Discussion will focus on challenges facing midwives including, embedding the Apps into a motivationally-designed portal, staff support and training, timeline, cultural differences and translation issues
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