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Improving the organisation of maternal health service delivery, and optimising childbirth, by increasing vaginal birth after caesarean section (VBAC) through enhanced women-centred care. (OptiBIRTH)

Contract/Grant agreement number: HEALTH – F3 – 2012-305208
EC contribution: €2,999,546
Duration: 54 months
Dates: 01/09/2012 - 28/02/2017
Instrument: FP7-HEALTH-2012-INNOVATION-1 HEALTH.2012.3.2-1. Improving the organisation of health service delivery

Optimal, healthy pregnancy followed by normal birth is the ideal. Caesarean section (CS) doubles the risk of mortality and morbidity (hysterectomy, blood transfusion), and increases the risk of postnatal infection by 5, compared with vaginal birth (WHO Global Survey on Maternal and Perinatal Health). The European Perinatal Health Report (2008) notes “widespread concern” over rising CS rates, which vary from 15% in the Netherlands to 38% in Italy. Much of the rise is due to routine CS following previous CS, despite calls for increased vaginal birth after caesarean (VBAC), which results in less mortality and morbidity and is the preferred option for the majority of women. VBAC rates in Ireland, Germany, and Italy are significantly lower (29-36%) than those in the Netherlands, Sweden, and Finland (45-55%), a difference equating to 160,000 unnecessary CSs per annum in Europe, at an extra direct annual cost of €156m.

To improve maternal health service delivery, and optimise childbirth, by increasing vaginal birth after caesarean section (VBAC) through enhanced patient-centred maternity care across Europe.

The OptiBIRTH trial investigated the effects of a woman-centred intervention designed to increase VBAC rates through an unblinded cluster randomised trial in 15 maternity units in three European countries with relatively low VBAC rates (Germany, Ireland and Italy). Randomisation of the maternity units occurred following trial registration (ISRCTN10612254), and before recruiting women. Maternity units were matched in pairs or triplets based on their annual number of births and VBAC rate, before being randomised 1:1 (pairs) or 2:1 (triplets) to intervention or control. Eligible participants were pregnant women (≥18 years) with one previous lower uterine segment CS. The intervention consisted of the provision of evidence-based education of women and clinicians, access to optional online resources, introduction of communities of practice (women and clinicians sharing knowledge), appointment of site midwife and obstetric opinion leaders, audit and peer review of CS rates in each site, and joint decision-making by women and clinicians. The control sites continued with usual care.

For this interim analysis, the primary outcome compares the proportion of women with one previous CS who had VBAC in each site in the calendar year before the trial (2012, n=5674) versus the final year of the trial (2015, n=5535), using routine, unit-level data. Between 1 April 2014 and 31 October 2015, 2002 women were recruited to the main trial (intervention 1195, control 807). Birthing data were available for 1956 of these (intervention 1174 (98.2%), control 782 (96.9%)) and mode of birth was available for 1940 women (intervention 1165 (97.5%), control 775 (96.0%)). The heterogeneity seen among the various sites was an unavoidable limitation.

The OptiBIRTH intervention was found to be feasible and safe across hospital settings in three countries. Overall at the level of the randomised hospitals, there is no statistically significant difference in the change in the proportion of women having a VBAC between the intervention sites (645 out of 2518, 25.6%, in 2012 to 720 out of 2682, 26.8%, in 2015) compared to the control sites (567 out of 3156, 18.3%, in 2012 to 567 out of 2853, 19.9%, in 2015) (odds ratio adjusted for differences between the intervention and control groups in 2012 and for homogeneity in the VBAC rates at sites in the countries: 0.89, 95% CI: 0.74, 1.07, p=0.22). However, the preliminary results from Italy showed a significant difference in VBAC rates in the intervention sites (from 8% (61 out of 736) to 22% (143 out of 652), RR 2.43 [1.84, 3.22]), which appears to show that the OptiBIRTH intervention may assist in supporting VBAC, especially in sites with very low VBAC rates. Among the recruited women, there were four perinatal deaths after 24 weeks gestation out of 1174 with birth data in the intervention group (0.34%) and four out of 782 in the control group (0.51%), and two uterine ruptures (one in each group).

As elective repeat CS is the most common reason for CS in multiparous women, and contributes to at least 10% of all CSs, any intervention that is feasible and safe and that may lead to a decrease of repeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. The OptiBIRTH intervention provides an evidence-based starting point for this research.

Project web-site: http://www.optibirth.eu/optibirth/

Key words: Vaginal birth after caesarean section, women-centred care, normal birth, randomised trial

Name: Prof Cecily Begley
Institution address: Trinity College Dublin, Ireland and Sahlgrenska Academy, University of Gothenburg, Sweden
Email: cbegley@tcd.ie

The project team developed from an ESF-funded workshop “Promoting Normality in Childbirth” and a COST Action (IS0907: Creating a Dynamic EU Framework for Optimal Maternity Care), and includes 11 partners from 8 countries representing service users, midwifery, obstetrics, epidemiology, sociology, bioethics, health economics and industry (SME).

List of participants: 
1 Trinity College Dublin, Dublin (TCD), Ireland
2 University of Gothenburg (UGOT), Sweden
3 Zuyd University (ZU), The Netherlands
4 University of Eastern Finland, Finland
5 University of Ulster (UU), UK
6 Entando (EN), Italy
7 Queen’s University of Belfast (QUB), UK
8 Medizinische Hochschule Hannover (MHH), Germany
9 National University of Ireland, Galway (NUIG), Ireland
10 Universita Degli Studi Di Genova (UNIGE), Italy
11 Vrije Universiteit Brussel (VUB), Belgium


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