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

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

Executive Summary:
Executive summary
Background
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 risk of postnatal infection five times, compared with vaginal birth. The 2008 European Perinatal Health Report 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.

Aim:
To improve maternal health service delivery, and optimise childbirth, by increasing VBAC rates, from 25% to 40%, through enhanced women-centred maternity care across Europe.

Method
The OptiBIRTH project brought together service users (women and their families), midwives, and obstetricians with researchers from epidemiology, health economics and industry in a 4-year project conducted in 8 EU Member States. An innovative, evidence-based intervention was designed to increase the empowerment, engagement and involvement of women with a history of one previous caesarean section, in their care. The intervention was designed following two systematic reviews of clinician-led and women-led interventions for increasing VBAC rates, and focus group interviews with 71 women and 115 clinicians in both high VBAC countries (Sweden, Finland and the Netherlands) and low VBAC countries (Ireland, Italy and Germany). The final intervention used a motivational design and consisted of: appointment of midwife and obstetrician Opinion Leaders (MOLs and OOLs) in each site; two antenatal education and support classes for women and their partners, of two hours each (inclusive of group meeting with the MOL and OOL at the end); a one-hour information session for clinicians. The intervention was translated into on-line format also, and a website and three mobile phone applications were developed.
The clinical effectiveness of the intervention was tested through a cluster randomised trial in 15 maternity units in 3 countries with low VBAC rates (Germany, Ireland and Italy), in small, medium & large units, in both urban & rural areas. A full cost and quality of life analysis was also conducted.

Findings
Overall, there was no statistically significant difference in the change in the proportion of women having a VBAC between the intervention sites (25.6% in 2012 to 26.8% in 2015) compared to the control sites (18.3% in 2012 to 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, preliminary results from Italy showed a signifi-cant difference in VBAC rates in the intervention sites (from 8% to 22%, 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). Women in the intervention group had a higher quality of life in the postnatal period. The intervention was cost-effective in Germany and Ireland, but VBAC rates in Italy would need to be increased for savings to be seen.

Conclusion
The OptiBIRTH intervention was found to be feasible and safe across hospital settings in three countries. 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 Context and Objectives:
Project context and objectives
Context:
Rates of caesarean sections (CSs) are increasing, yet decreases in maternal and perinatal mortality are not seen when more than 10% of births in a population are by CS (Ye et al. 2015). Between 1990 and 2014, average CS rates increased from 6.7% to 19.1% globally, and from 11.2% to 25% across Europe (Betran et al. 2016). In 2010, CS rates in 31 countries and regions in Europe ranged from 14.8% in Iceland to 52.2% in Cyprus (Macfarlane et al. 2016), with highest rates among women who had had a previous CS. These were between 45% and 55% in the Netherlands, Norway, Finland and Iceland, 64% in Germany, approximately 90% in Italy, and not reported in several countries, including Ireland (Macfarlane et al. 2016). Similarly, CS rates in Australia ranged from 11.8% to 47.4% across 81 hospitals (Lee et al. 2013), with rates of 82.1% among 61,894 maternities with a previous CS (Schemann et al. 2015). Less than half (49%) of the variation in repeat CS rates in the latter study was explained by differences in women’s characteristics and hospital practices, indicating the association of other, non-clinical, factors (Schemann et al. 2015).

Elective repeat CS (ERCS) and planned vaginal birth after CS (VBAC) for women with a prior CS are both associated with benefits and harms (Dodd et al. 2013). Most studies report an increase in adverse maternal and neonatal outcomes following repeat CS (Morrison et al. 1995, Lobel and DeLuca 2007, Villar et al. 2007). The findings of one systematic review reported that maternal mortality is decreased by planned VBAC compared with ERCS, with nine fewer deaths per 100,000 women (Guise et al. 2010). Significant increases in perinatal mortality were seen for “trial of labour” (0.13% compared with 0.05% for ERCS), but the authors concluded that, as the absolute risk of perinatal death is low, the evidence suggested that VBAC was a reasonable choice for the majority of women (Guise et al. 2010).

In response to rising CS rates in the United States, the National Institute for Health and the American College of Obstetricians and Gynaecologists (ACOG) issued guidelines recommending “trial of labour after CS”, as they termed it, in 2010 (Cunningham et al. 2010, ACOG Practice Committee 2010). Two years later, 44% of hospitals in California still did not permit planned VBAC, and one tenth of the other 56% of hospitals that did allow planned VBAC reported that fewer than 3% of women who had had a previous CS had a vaginal birth (Barger et al. 2013). This indicates how difficult it can be, and how long it can take, to change clinician opinion. Given the variation in VBAC rates across Europe it is clear that improvements in care can be made. 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.
Aim:
The aim of the OptiBIRTH project was thus to improve maternal health service delivery, and optimise childbirth, by increasing vaginal birth after caesarean section (VBAC), from 25% to 40%, through enhanced patient-centred maternity care across Europe. This aim was achieved through seven work-packages, with a total of 19 objectives.
Objective WP1:
• To arrange and manage project meetings, documentation, events and communicat-ion and to provide support to partners, the Data Safety Monitoring Group, and the Advisory Board (AB).
• To ensure appropriate accessibility of information through project website.
• To ensure that financial reports and RTD progress reports are submitted by partners in accordance with schedules, and that annual reports are made to the AB.
• To submit annual financial, interim and periodic reports to the EC, in compliance with the reporting requirements of the Technical Annex and EC Grant Agreement.
Objective WP2
• To conduct a systematic review of the literature (or review of reviews) on women-centred antenatal interventions for increasing VBAC rates and reducing fear of childbirth in women;
• To conduct a systematic review of the literature (or review of reviews) on clinician-centred interventions for increasing VBAC rates and reducing fear of childbirth in women & apprehension in clinicians;
• To develop and conduct focus-group interviews (FGIs) with women, their partners and clinicians in maternity care settings with high VBAC rates (Sweden, Finland and the Netherlands), to ascertain cross-cultural views on VBAC and to determine what works/does not work in increasing VBAC;
• To develop and conduct FGIs with women, their partners and clinicians in maternity care settings with low VBAC rates (Germany, Ireland and Italy, to ascertain cross-cultural views on/barriers to VBAC, views on fear in childbirth and on clinical decision-making from their respective roles;
• To develop and refine, based on the information afforded by the four above objectives, the face-to-face women-centred intervention for testing in WP4.
Objective WP3
• To develop, and maintain, an interactive “OptiBIRTH” website hosting a motivationally-designed version of the proposed intervention developed in collaboration with, and following on from, the work of WP 2.
• To develop mobile apps and e-learning resources designed to facilitate women in their decision making, goal-setting and optimal achievement, related to VBAC.
Objective WP4
• To use a cluster randomised trial to evaluate the effectiveness of the intervention.
Objective WP5
• To determine variation in costs between countries (base comparison)
• To determine cost-effectiveness of the intervention, as measured in the RCT (WP4)
Objective WP6
• To agree implementation plans with key policy-makers in the 3 trial countries, that could be adapted for use across the EU.
• To report project results to the Commission, and to key stake-holders.
• To disseminate project results widely to the public, maternity care clinicians and researchers, childbearing women, and healthcare policy-makers.
• To exploit results of the project to the fullest commercial extent
Objective WP7
• To ensure that the project is planned and managed in an efficient, effective, and safe manner so that it achieves its objectives, milestones and key deliverables on time, to a high standard and within budget, in accordance with the EC Grant Agreement and Consortium Agreement.
• To monitor the progress of the project in accordance with the project schedule and deliverables, to identify and deal with risks, and to ensure that the project delivers the expected impacts.
• To ensure ethical conduct and excellence in all aspects of the scientific research.

Methods
The OptiBIRTH Project was granted ethical approval by Trinity College Dublin prior to study start (27th June 2012). Approval for the Project (focus group interviews and trial) at individual country level was also granted by the relevant research ethics committees. All ethics approval letters were included in deliverables 2.1 and 4.1.
Intervention development
To develop the intervention, we conducted two systematic reviews of relevant literature. The review of clinician-focussed interventions showed that the only strategy that significantly increased VBAC rates was an educational intervention provided by an opinion leader (Lundgren et al. (2015a). The review of women-centred interventions found that information sessions and decision-aids for women during pregnancy did not increase VBAC rates but did significantly decrease women’s decisional conflict and increase their knowledge of mode of birth (Nilsson et al. 2015a). We also conducted focus group interviews (FGIs) with 44 clinicians practising in three countries with high VBAC rates (>45%) (Lundgren et al. 2015b), and 71 clinicians from countries with low VBAC rates (Lundgren et al. 2016). Findings showed that trust in the clinician–woman relationship, a positive attitude of all centrally involved, early follow-up and fear reduction were important to all clinicians. However, differences were found related to the decision-making process, parameters for VBAC, organisation-al support and resources, and clinical expertise, which indicated different attitudes and views among clinicians in countries with high and low VBAC rates. We also conducted FGIs with 71 women in the six countries, which showed the need for education and support from committed clinicians (Nilsson et al. 2015a), findings similar to our previous work (Lundgren et al. 2012).

The final complex, innovative intervention used a motivational design and consisted of: appointment of midwife and obstetrician Opinion Leaders (MOLs and OOLs) in each site; two antenatal education and support classes for women and their partners, of two hours each (inclusive of group meeting with the MOL and OOL at the end); a one-hour information session for clinicians. The intervention was translated into on-line format also, and a website and three mobile phone applications were developed (Sinclair et al. 2016). Sites randomised to the intervention group received the intervention, delivered by the midwife and obstetric ‘opinion leaders,’ supported by researchers from the OptiBIRTH team. A checklist was developed to assess, monitor and evaluate adherence to the intervention in each site, and was applied twice, once during the pilot phase and once during the main trial. Details of the attendance of clinicians at educational sessions, and women at the antenatal classes, the use of online resources and adherence to the intervention were monitored during the trial, in each intervention site. Sites randomised to the control group followed the usual practice for that unit.
Study design
A cluster randomised trial was conducted of 15 urban and rural maternity units (annual births 1800 to 8500) in Germany, Ireland and Italy, with VBAC rates of 35% or less. To allow for clustering, an estimate of the sample size for an individually randomised trial was adjusted and inflated by the design effect given by 1 + (ñ-1)ρ, where ñ was the average cluster size and ρ was the estimated intra-class correlation coefficient (ICC) for this study. With a background proportion of successful VBAC of 25% and an ICC of 0.05, 12 sites would have been required, each containing 120 participating women (840 women in the intervention group and 840 women in the control group), to detect a 15-percentage point difference in successful VBAC (i.e. an absolute increase from 25% in the control group to 40% in the intervention group), with power of at least 80% and an alpha level of 0.05. Five maternity units took part in each country, with two units in Hannover (Germany) being allocated to the same group to avoid having an intervention and a control site in the same city. A pilot study was conducted from January-April (Germany), February-March (Ireland) 2014 and February-April (Italy). Minimal changes were made to data collection, selection, enrolment processes and the length of the clinician information session during the pilot phase and the main trial results exclude women recruited during the pilot study.
Randomisation and blinding
The unit of randomisation was the maternity unit (the “site”). Primary analyses considered women’s data at the level of each site as a whole, rather than at the level of women recruited. This was done to investigate the effects of the OptiBIRTH intervention on a cultural change in practice, affecting the care of all women with one previous CS. Randomisation of sites was done in advance of recruiting women to participate. The maternity units that had agreed to join the trial were matched by their annual number of births and then by VBAC rate in each country, in either pairs or triplets. They were then randomised 1:1 or 2:1 to intervention or control, respectively (Clarke et al. 2015). Blinding of clinicians and women was not possible because they were part of the intervention. However, results of the trial were kept blind from the trial team until recruitment closed and analyses were completed.
Eligibility
Pregnant women at a participating site
(1) were aged 18 years of age or over at time of booking
(2) had one previous lower segment CS (not a classical/high vertical incision)
(3) spoke the language of the country where they were recruited (German, English or Italian)
(4) gave informed consent to participate

Pregnant women with known multiple pregnancy at time of booking were ineligible. Women gave their consent to participate in the trial at one of two levels: full participation, if they wanted to attend the OptiBIRTH antenatal classes; or routine data only, which gave us permission to access the healthcare records for the woman and her baby. Ethical approval was granted by Trinity College Dublin, Ireland and Research Ethics Committees for all countries’ participating sites.
Data collection
Women in each site were screened for eligibility for OptiBIRTH at their first visit, using a pre-designed Trial Screening and Register Form. Women judged eligible were informed of the study verbally and received a study pack, which included a detailed information leaflet and consent form. On receipt of the signed consent form, women were contacted by the midwife opinion lead (MOL) for the site and those in intervention sites provided with further details on accessing the intervention.
All outcome data were collected using pre-designed data forms. These included self-report of antenatal and postnatal health and healthcare resource use and expenditure surveys, and clinician-reported labour and birth outcome data.
Primary outcome
The pre-specified primary outcome for the trial was the proportion of women with one previous CS who had a vaginal birth in each site comparing the calendar year before the trial (2012) versus the year after the trial (2016), to assess the sustainability of any intervention effect at site level. However, for the purposes of the preliminary analysis presented in this report, the primary outcome compares such rates in each site for 2012 versus the final year of the trial (2015), when the intervention was still being provided to the intervention sites in the context of the trial.

Project Results:
Main S&T results/foregrounds

Results of the main trial

Recruitment to the main trial

Women were recruited to the main OptiBIRTH trial from 1 April 2014 in Ireland (n=622) and from 1 May 2014 in Germany (n=755) and Italy (n=625). Most sites closed when they reached their target of 120 participants, during March-May 2015. Formal closure of recruitment was on 31 October 2015. The data set was closed for the purposes of this report on 2 July 2016. Across the 15 sites, 5674 women (intervention: 2518; control: 3156) who had had one previous CS birthed in 2012, compared to 5535 women (intervention: 2682; control: 2853) in 2015. In the main trial, 2002 women were recruited across the 15 sites in the three countries (Figure 1). A total of 1831 women agreed to full participation (intervention: 1073; control: 758), and a further 171 agreed to partial participation (allowing use of their birthing data only) (intervention: 122; control: 49).

Baseline data are available on all 2002 women (intervention: 1195; control: 807) who had agreed to take part and some birthing data are available for 1956 (97.7%) (intervention: 1174 (98.2%); control: 782 (96.9%)) of these (Table 1 and Appendix Tables 1-3).

Table 1 shows that there were statistically significant imbalances between the intervention and control groups for women who had had a VBAC between their previous CS and their OptiBIRTH pregnancy in Italy, and gestational age at recruitment for the trial as a whole and in Germany. Our adjusted analyses investigate the effect of all imbalances in baseline variables on the findings of the trial, regardless of the statistical significance of the imbalance.


Primary outcome: birth outcomes using site-level data
Table 2 shows the numbers of women in each of the 3 countries who had had a single previous CS and birthed in 2012 and in 2015, and the number and proportion of these whose birth was a VBAC. The changes in the proportions of VBAC for women with one previous CS between these two years is also shown for each country and overall without (Table 2) and with adjustment (Figure 2).

Overall, there was no evidence of a significant effect while adjusting for differences between the intervention and control groups at baseline (year 2012) due to randomisation at site level and for homogeneity in the VBAC rates at sites in countries (odds ratio: 0.89, 95% CI: 0.74, 1.07, p=0.22). There was an overall (absolute) non-significant increase in the VBAC proportion in the control sites of 1.7% (p=0.11), a lack of change in the intervention sites (0.0%, p=0.96) and no significant difference in the change over time between groups (p=0.26). In Germany, there was an absolute non-significant reduction in the VBAC proportion in the control sites of 2.5% (p=0.40), an absolute non-significant reduction in the intervention sites of 2.4% (p=0.28) and no significant difference in the change between groups (p=0.97). In Italy, there was a significant absolute increase in the VBAC proportion of 6.4% in the control sites (p<0.001) and 12.6% (p<0.001) in the intervention sites and a significant difference in the change between groups where improvement in the VBAC proportion is significantly higher in the intervention sites, by 6.2% in absolute terms (p<0.001). In Ireland, there was an absolute non-significant decrease in the VBAC proportion in control sites of 1% (p=0.55), a significant absolute decrease in the intervention sites of 6.5% (p=0.006) and a significant difference in the changes between groups, where the reduction in the VBAC proportion is significantly larger in the intervention sites, by 5.5% in absolute terms (p=0.028).

Birth outcomes, using data for recruited women
Mode of birth
Table 3 shows the mode of birth for women who agreed to join the trial in each of the countries and for the trial overall. No birth data are available for 46 of the 2002 recruited women (for example, because they moved to a different area or gave birth elsewhere), and mode of birth is not available for a further 16 women who had an intrauterine death at less than 24 weeks gestation (n=8) or more than 24 weeks (3) or for whom the mode of birth was missing at the time of data lockdown (5). Therefore, of the 1940 recruited women with known mode of birth, 385 (33.0% of 1165) in the intervention group and 223 (28.8% of 775) in the control group had a VBAC, but there is substantial statistical heterogeneity across the six randomised comparisons (Figure 3). There is a statistically significant relative increase in VBAC of 16% for the intervention group compared to the control group (risk ratio (RR): 1.16; 95% CI: 1.01, 1.33; p=0.03), with an absolute increase of 5% (95% CI: 0%, 9%) for the intervention group compared to the control group. However, when this analysis is adjusted for the baseline characteristics, the difference becomes non-significant. It is also not significant if the random effects model is used for the meta-analysis (RR: 1.19; 95% CI: 0.88, 1.62; p=0.28).

Onset of labour
Of the 1956 women for who some birth data are available, onset of labour was spontaneous in 445 (37.9% of 1174) in the intervention group and 281 (35.9% of 782) in the control (RR: 1.07; 95% CI: 0.95, 1.21; p=0.25), a non-significant difference. Labour was induced for 82 women (10.5%) in the intervention group and 49 (6.2%) in the control. The remaining women had CS without going into labour, 647 (55.1%) in the intervention group and 452 (57.8%) in the control group.

Of the 857 women who laboured (for all of whom we have birth data), labour onset was spontaneous in 445 (84.4% of 527) in the intervention group and 281 (85.2% of 330) in the control (Table 4) (RR: 0.99; 95% CI: 0.93, 1.05; p=0.62), a non-significant difference. Labour was induced for the other 82 (15.6%) in the intervention group and 49 (14.8%) in the control group who laboured.
Out of the 857 women who laboured, labour was accelerated in 226 women (42.9% of 527) in the intervention group and 146 (44.2% of 330) in the control group (RR: 0.99; 95% CI: 0.85, 1.16; p=0.88), a non-significant difference.

Uterine rupture
Data on all reported uterine ruptures were reviewed, to distinguish between scar dehiscence and full uterine rupture; there were two full uterine ruptures in the main trial (one in each group), one following an induced labour, the other spontaneous. Both women and babies were discharged home well by day 5 and day 4 respectively.

Subgroup analyses for maternal outcomes
Caution is needed in the interpretation of subgroup analyses, when the overall result is not statistically significant (Clarke and Halsey 2001, Peto 2011). However, for completeness, Table 5 presents the main maternal outcomes within the pre-specified subgroups. This shows variable effects in different subgroups. However, given the number of such analyses, the relatively small number of women in some subgroups, and the challenges of recruiting participants in a cluster randomised trial when the allocation cannot be concealed, there is no strong evidence of clear benefit or harm for the OptiBIRTH intervention in any of the subgroups. Given the possibility that women who were recruited late to the trial (at or beyond week 33 of their pregnancy) might lead to an underestimate of any effect of the intervention, a sensitivity analysis was done excluding such women. This found a RR of 1.08 (95% CI: 0.88, 1.31, p=0.46) for VBAC comparing the intervention and control groups.

Antenatal and neonatal outcomes, using data for recruited women
Table 6 shows neonatal outcomes for women who agreed to join the trial. These data use the birth data that are currently available for 1956 (97.7%) of the 2002 recruited women.

A total of 16 pregnancies (intervention: 11; control: 5) ended in intrauterine death, 10 before 24 weeks’ gestation (intervention: 7; control: 3) and six after (intervention: 4; control: 2). Taken separately, or combined, there was no significant difference in these deaths between the intervention and control groups. Two of the recruited women experienced a neonatal death, both in the control group, giving total perinatal death figures, after 24 weeks gestation, of four out of 1174 (0.34%) for whom some birth data are available in the intervention group and four out of 782 in the control (0.51%).

Of the 1940 babies born alive (and for whom we have birth data, excluding the second twin born to a woman in the control group), 62 babies (5.3% of 1163) in the intervention group were born before 37 weeks gestation, compared to 50 (6.4% of 777) in the control group (Table 6) (RR: 0.81; 95% CI: 0.56, 1.17; p=0.26), a non-statistically significant difference (95% CI: -3%, 1%). Similarly, there was little difference in mean gestational age at birth between babies in the intervention (mean: 38.9 weeks; SD: 1.5) and control (mean: 38.7 weeks; SD: 1.8) groups. This difference of approximately one day is of borderline statistical significance in the unadjusted analysis (p=0.05, 0.07 weeks, 0.28 weeks).

Of the 1163 live-born babies in the intervention group for whom data are available, 90 (7.7%) were admitted to NICU compared to 63 (8.1% of 777) in the control (Table 6) (RR: 0.87; 95% CI: 0.64, 1.17; p=0.36), a non-significant difference.

Subgroup analyses for neonatal outcomes
For most neonatal outcomes, the small number of events does not warrant dividing the analyses into subgroups using baseline characteristics of the mothers. However, Table 7 shows these subgroup analyses for three outcomes: birth before 37 weeks, gestational age at birth and admission to NICU. As with the subgroup analyses for maternal labour and birth outcomes (Table 5), this shows variable effects in different subgroups, but without any strong evidence of clear benefit or harm for the OptiBIRTH intervention for the babies based on any of the subgroups.

Results of the health economics section
Preparatory work
Mixed methods were used to complete this section of the study. Initially, a literature review was conducted on resource utilisation in perinatal care, followed by identification of cost categories and subitems. Data were then collected on national unit costs for these items, with the support of national experts. Finally, the developed framework was piloted by linking healthcare utilisation and national costs (Table 8).

This showed that there was considerable variation in healthcare utilisation and costs in ‘standard’ perinatal care between countries. However, the framework (identification of categories and national unit costs) was completed for all three countries involved in the OptiBIRTH trial, and served as a basis for the health economic evaluation
The next step was to build a suitable model, based on previously published models and adapted for the OptiBIRTH project. First the target population was defined, and a decision tree developed, which included the various possible states. The model was then populated with probabilities, costs and utilities (measured as QALYs), and piloted for four EU countries (Belgium, Germany, Ireland, Italy), comparing VBAC with elective repeat caesarean delivery (ERCD) based on a hypothetical cohort. The main research question posed was: is it cost-effective if all eligible women have VBAC compared with when all would have ERCD?
The results showed that VBAC was the dominant strategy, with gains in QALYs at a lower cost compared to ERCD. The reduction in costs differed from €4,639,037 (Germany) to €71,768,175 (Ireland) per 100,000 women. The QALY gains differed from 5,858 (Italy) to 7,573 (Germany) per 100,000 women. The incremental cost-utility ratios (ICURs) were as follows: €-569/QALY (Germany), €-2,113/QALY (Belgium), €-3,247/QALY (Italy), €-11,021/QALY (Ireland).

Data collection alongside the main trial
Data were collected on self-reported health care utilisation. Women in both groups were requested to complete antenatal and postnatal booklets, with questions covering general health, wellbeing (measured by SF-36 (SF-6D) at inclusion and at 3 months postnatal), and costs of ambulatory care (national unit costs), inpatient care (DRG), and intervention costs (in the intervention arm).

Results
Resource utilisation during outpatient care is shown in Table 9.

The healthcare costs in each country for all periods of pregnancy and childbirth are shown in Table 10.

Figures 4 and 5 illustrate the costs involved during the antenatal and postnatal periods in each country – Germany, Ireland and Italy respectively.

Quality of life
The quality of life results are shown in the following three figures (Figure 6). In terms of time, hte lines go from the antenatal period on the left, to the postnatal period on the right. The green lines in each figure show the intervention group’s increase in QOL from the antenatal to postnatal period, which in each country is greater than the increase in QOL in the control group (blue line).

The cost-utility analysis (CUA) showed the following results:
• ICUR Germany: € 31,280.55/QALY
(Δcost: 176.03, ΔQALY: 0,01) ~ threshold € 36,000/QALY
• ICUR Ireland: € 6,172.50/QALY
(Δcost: 172.00, ΔQALY: 0,03) ~ threshold € 45,000/QALY
• ICUR Italy: € 109,788.55/QALY
(Δcost: 1346.06, ΔQALY: 0,01) ~ threshold € 27,000/QALY

Previous analysis was based on the base values derived from the trial data. However, each of these parameters show a distribution which should be accounted for. If the parameters are varied according their respective distributions, the ICUR also varies.

The top graph illustrating results for each country in Figure 7 below, depicts the various ICURs when we vary the input parameters (bootstrapping). We then evaluated on the probablity of being cost-effective by a calculation of how many iterations are below the threshold and repeated that for each threshold. These are shown in the second (lower) series of graphs for each country. They show what the probabilty is of being cost-effective (Y-axis) for the various thresholds (X-axis).

For some simulations in Ireland and Germany the OptiBIRTH intervention generates more QALYs and fewer costs, however, for others there is a QALY loss and a cost increase, seen certainly in Italy.

Overall, the OptiBIRTH intervention results in QALYs gain for all three countries and a significant increase in costs for Italy. Although there was no significant increase in the VBAC rates, the CUA shows positive trends. Further improvement of the VBAC rates would result in improved health economic results, but there is still high uncertainty in the results.

Results of study in Ireland on women’s and clinician’s views and experiences of the intervention

An anthropological study of cultural change was conducted within one site involved in the randomised trial. The aim of this study was to evaluate cultural change before, during, and after the implementation of a complex intervention (within OptiBIRTH) designed to increase VBAC in women who have had one previous CS, in one intervention site. An ethnographic research design was used, and access and ethical approval for this embedded ethnography was granted by the HSE Mid-Western Regional Hospital Research Ethics Committee and the Faculty of Health Sciences Ethics Committee, Trinity College Dublin.

Data were collected through participant and non-participant observation at 16 antenatal classes, and over 16 months in the antenatal clinic. Semi-structured interviews were also conducted with 15 women (19 interviews) participating in the trial and 14 clinicians caring for them (16 interviews).

The findings indicated that
➢ the changing of women’s identities,
➢ the transference of authoritative knowledge, and
➢ the effect of various power positions
affected the intervention and its status in the field-site.

The changing of women’s identities
The ‘OptiBIRTH identity’ was quite apparent. Women identified with the development of a ‘sub-group’, of women who have had a previous CS and are now looking at other methods of birth for their present pregnancy, specifically to have a natural birth. Examples of quoations illustrating this concept were:

• “It’s just great hearing other women’s experiences as well and what they’ve gone through and what they’re hoping to do this time as well”. W3(Interview)

• “I’m not the only one. We’re all in the same boat”. W6(Fieldnote)

• “I kind of thought that it wasn’t an option, originally, to have a VBAC, but now I do and I kinda think, ‘ok they’re gonna try and help me have one’, you know? Help me as far as possible and sure, if it doesn’t work out it doesn’t work out, but at least I can go and give it my best shot.”W1(Interview)

The researcher witnessed a shift in language used from class to class, from a more uncertain opinion on natural birth to a more positive framework of communication.

• The OOL listens to every woman’s previous birth experience, he goes on to explain why they may have had the CS and ends the conversation by telling them that they are “a suitable candidate” or “you’re right up our street”. (Fieldnote)

• There were four women attempting a VBAC in the labour ward. The women could not believe it and looked at each other in surprise. (Fieldnote)

• The OOL also provides many anecdotes regarding his experience of VBAC and the women achieving it. (Fieldnote)

It is these stories and anecdotes that enable women to grasp the reality that a natural birth after a CS does occur and facilitates a positive framework of thinking about VBAC to take centre-stage in the class.

Transference of authoritative knowledge

In the interactions that occurred in the antenatal classes and the clinician information sessions, there was a transference of authoritative knowledge on VBAC and its viability as a method of birth after a CS. The OptiBIRTH women gained the knowledge that allowed them to make an informed decision on the birth they wanted and to have an informed conversation with their clinician about the risks and benefits of VBAC.

• “What it really did do, though, was raise my awareness ...I assumed that a C-section, you were almost destined to have another C-section. What it really raised my awareness around is that every birth is different and that you kind of have to go with the experience. I think that has prepared me for the next delivery” (Interview)

The effects of power positions

• The OOL asked the women in every class if they were already going to his clinic. (Fieldnote)

• If a woman tells him that they are, he suggests to them towards the later stages of their pregnancy to ask to see him personally so that he can examine them in his clinic. (Fieldnote)

• If there are women in the class that do not attend his clinic, he mentions to the women about potentially changing to is clinic “because of the study.” (Field-note, July 2014)

• If a woman does not want to move to his clinic for antenatal care, he is supportive of their decision and lets them know that they can achieve a VBAC even if they are not being taken care of in his clinic. (Field-note, July 2014

From the very beginning of the second class, induction of labour came up in conversation with the OOL. Many of these conversations centred on his practice around induction (e.g. giving the women “1/2 a gel”) and that his colleagues in the hospital did not believe in induction in women who had a previous CS. The OOL spoke of “Controlling it [labour] and watching it like a hawk” (Field-note, January 2015) and that “personally, I’ll give my ones a chance” (Field-note, February 2015)

While the overall culture in the field-site did not change, smaller, more individual cultural changes were observed, from both the women and clinicians taking part. However, the absence of participation by senior consultants and doctors was found to hinder the implementation of the intervention and it was the women who were driving change around mode of birth after CS. This suggests that the women who participated did not hamper VBAC uptake, rather it was the clinicians who did not engage fully with the intervention.

• “It’s about trying to change the culture in the hospital, which I think the main aim of OptiBIRTH is. I’m trying to change it into a more pro-VBAC, or prochoice, I suppose, clinical environment. Really, that’s probably been the hardest part of it.” (Interview, C7, June 2015)

• “Some midwives will say to me they didn’t realise the chance of, em, having a normal delivery...could be as high as 75%.” (Interview, C7)

• “They thought it was something around 30%....so definitely I can see...information that I’ve been giving to them in the clinician sessions, I’ve heard them repeating to the women which is actually great!” (Interview, MOL)

• She told me that a huge argument had happened between the registrars about having VBAC as a choice, and having unnecessary sections in the hospital. I couldn’t believe it! [She] told me that this all came about because she did the CS rates for the hospital and...some of the consultants had a far higher section rate than others and that when she told [Consultant], he flatly refused to believe that was his CS rate. (Field-note)

• Overall it would seem that the intervention is generating both conversation and tension between doctors who are pro-VBAC and those who value the repeat section. (Field-note, April 2014)

It was apparent from analysis of all the data gathered that, through the active incorporation of the OptiBIRTH intervention into the field-site, thought around the subject of VBAC and repeat CS has slowly changed, but needs further time to change the culture completely. It is recommended that MOLs should also be appointed in the labour ward, to support the midwives and obstetricians there.

Discussion
We have demonstrated through this cluster randomised trial that, in these hospital settings in three countries, the OptiBIRTH intervention is feasible and safe. Overall, in this preliminary analysis we found no statistically significant difference in the change in the proportion of women having a VBAC between the intervention sites (25.6% in 2012 to 26.8% in 2015) compared to the control sites (18.3% in 2012 to approximately 19.9% in 2015). This is not surprising as change in clinical practice is notoriously slow (Oxman et al. 1995), and both clinicians and women need time to become accustomed to new approaches to care. In particular, complex interventions such as that developed for OptiBIRTH require the passage of time and a willingness to engage with them to ensure uptake. The anthropological study showed that some change was taking place in clinicians’ attitudes, which may show in improved VBAC rates in our follow-up study to be conducted in 2017. A continuance of slow change over the next few years, resulting in an improvement in VBAC rates of even 5% would be clinically significant.

In Italy, where VBAC rates in intervention and control sites were lower pre-trial (8.3 and 10.6%) compared with Ireland and Germany (32.1% and 22.2%, and 33.7% and 27.3%), VBAC rates increased to a greater extent. The overall VBAC rate rose in intervention sites in Italy from 8.3% in 2012, to 21.9% in 2015, the last year of the trial. Thus, in countries or sites where VBAC rates are very low, the OptiBIRTH intervention may be more effective within a shorter time frame. The VBAC rate in control sites in Italy also rose from 10.6% to 16.3% in the same time, which may be due to the Hawthorne effect where being involved in the study, even in the control group, may have encouraged clinicians to review their practice, and offer VBAC rather than elective repeat CS.

There was a statistically significant absolute increase of 4.3% in the VBAC rate (95% CI: 0%, 9%) (32.8% in the intervention group, 28.5% in control) (RR: 1.16; 95% CI: 1.01, 1.33; p=0.03) when comparing the birthing data available for women who agreed to join the trial (intervention: 1174 (98.2%) and those in the control: 782 (96.9%)). However, when this was adjusted for baseline characteristics, the difference was no longer statistically significant. No differences were seen in rates of induction or acceleration of labour between the two groups. This increase in VBAC among women who took part in the intervention may indicate that the intervention needs to be encouraged across the board, with both clinicians and women taking part to ensure any change in practice.

A break-down of the results shows apparent anomalies in some countries. For example, in the Irish intervention sites there was an overall drop in VBAC rates from 32.1% (2012) to 25.5% (2015), while the data from women participating in the trial in those sites showed a rate of 34.2%. This suggests that the VBAC rate for women not in the trial in 2015 was much lower than the 2012 norm. Evidence to support this comes from the drop in VBAC rates between 2012 and 2015 years occurring, for some reason, in one of the three Irish intervention sites only. Recent work on VBAC rates in two of the largest maternity hospitals in Ireland corroborates this evidence, showing a steep decline from 64.4% in 1990 to 32.9% in 2014, with rates still falling from 2012 to 2014 (Brick et al. 2016). Similar decreases were also shown in Massachusetts, from 32%, to rates below 10% for the decade 2000-2010, and in one area of Germany, which showed a decrease from 48% in 1990 to around 25% in 2012 (Brick et al. 2016). These decreases may be a reaction to the publication of a number of studies in the late 1990s and early 2000s that highlighted the risks of VBAC, without taking account of the international consensus that VBAC, using evidence-based guidelines, is a clinically safe choice for most women with a previous CS (Brick et al. 2016). In the OptiBIRTH trial, VBAC rates in the Irish intervention sites actually decreased from 32.1% to 25.5% over the time-period of the study (2012-2015); this may have been affected by many reports in the Irish media, including an investigation into maternity care practices at one of the participating sites and, in particular, one situation where a maternity hospital sought a court order (unsuccessfully) to compel a woman to have a CS (White 2013).

Elective CS differed between the two groups (42.9% in intervention and 50.3% in control), perhaps indicating that the intervention had some effect in supporting women and clinicians in deciding to plan a VBAC. However, there was an increase in the rate of unplanned CS prior to labour in the intervention group (12% compared to 7.3%), which may have indicated a change of mind, or the emergence of clinical factors preventing a planned VBAC. In terms of safety, there were two full uterine ruptures in the main OptiBIRTH trial (one in each group), a rate of 1 per 1000, lower than the published rate of 2.1 per 1000 maternities previously identified (Fitzpatrick et al. 2012). Intra-uterine and neonatal death rates showed no difference between intervention and control groups, and were equivalent to or below the lowest quoted European rates (EURO-PERISTAT Project 2013). Other neonatal outcomes examined (admission to NICU, and preterm birth) also did not differ significantly between the two groups.

Limitations of the OptiBIRTH cluster trial include missing data from 46 of the 2002 recruited women who moved away, or gave birth in another maternity unit (2.3%). The heterogeneity seen in the various sites is also an unavoidable issue in cluster randomised trials, and is a reality in ‘real world’ research. The results of this trial may not be generalisable, because other settings, with different participants, fewer or more resources and differing extents of training or motivation of healthcare professionals could produce different results. In this study, in settings with high rates of repeat CS for women with one previous CS, clinicians and women alike may view repeat CS as usual and beneficial. Belief in increased rates of uterine rupture with planned VBAC, and exaggerated fears of the ensuing complications (Turner 2014) should not prevent clinicians from offering, and supporting women to achieve, VBAC. Providing the OptiBIRTH intervention in other settings could produce different results, especially if time is spent informing clinicians and policy-makers of these results, and the safety of the intervention, when applied as it was in this study.

In summary, our results showed no significant difference in adverse maternal or neonatal outcomes between women exposed to the OptiBIRTH intervention and those who were not. The preliminary results appear to show that the OptiBIRTH intervention may assist in supporting VBAC, especially in sites with very low VBAC rates. As elective repeat CS is the most common reason for CS in multiparous women, and contributes to at least 10% of all CSs (Rossignol et al. 2013), any intervention that is feasible and safe, and that may lead to a decrease of elective CS should be promoted. Continued research to refine the best way of promoting VBAC is essential.

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Potential Impact:
The potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The world-wide crisis in maternity care, caused by rising CS rates, has been critiqued by the WHO. In the United States, the National Institute for Health and the American College of Obstetricians and Gynaecologists (ACOG) issued guidelines recommending VBAC, in 2010 (Cunningham et al. 2010,
ACOG Practice Committee 2010). However, two years later, 44% of hospitals in California still did not permit planned VBAC, and one tenth of the other 56% of hospitals that did allow planned VBAC reported that fewer than 3% of women who had had a previous CS had a vaginal birth (Barger et al. 2013). This indicates how difficult it can be, and how long it can take, to change clinician opinion.

The anthropological section of the OptiBIRTH study showed that, after 18 months of the trial, some alteration was taking place in clinician attitudes. The improvement in VBAC rates in the intervention group in Italy (from 8% to 22%) shows that, when clinicians are motivated to modify their practice, change can take place. If all European countries with VBAC rates below 36% (e.g., Ireland, Germany, and Italy have rates of 29-36%) are compared with the possible rates of VBAC, as shown in countries such as the Netherlands, Sweden, and Finland (rates of 45-55%), it can be seen that there are 160,000 unnecessary CSs being performed per annum in Europe.

Successfully increasing VBAC rates in all European countries will reduce that number of unnecessary CSs, thus reducing the concomitant maternal morbidity and mortality, increasing women’s quality of life, and making cost savings of up to €156m annually. Clinicians now need to rise to the challenge of questioning their present practice and changing it, in line with the evidence.

The main dissemination activities and exploitation of results

The OptiBIRTH project has generated 10 peer-reviewed publications and 28 oral/poster presentations at national and international conferences. In addition, the team presented the results of the whole study on 11 occasions; at three one-day conferences in the three trial countries Germany, Ireland and Italy, and at eight half-day seminars for women in the eight countries involved in the study: Ireland, Germany, Italy, Belgium, UK, the Netherlands, Finland and Sweden. Considerable media interest was generated in Ireland, in particular, with 13 examples of media responses, as follows:

OptiBIRTH media coverage

Print:
http://www.irishtimes.com/life-and-style/health-family/the-case-for-a-vaginal-birth-after-a-caesarean-1.3023313
http://www.irishexaminer.com/breakingnews/ireland/a-third-of-pregnant-irish-women-opt-for-c-sections-778101.html
http://www.breakingnews.ie/ireland/a-third-of-pregnant-irish-women-opt-for-c-sections-778101.html
http://www.irishexaminer.com/ireland/caesarean-birth-rate-in-ireland-about-three-times-the-recommended-figure-443477.html
http://www.newstalk.com/What-is-behind-Irelands-booming-caesarean-section-rate

Broadcast
• Newstalk radio – High Noon with George Hook – 21st February
• Almost one in three pregnant women in Ireland have Caesarean sections
• NewsTalk, 21 Feb 2017
• Almost one in three pregnant women in Ireland have Caesarean sections. A new study from Trinity College and NUI Galway shows that this rate has increased dramatically in the past few years and it is now more than double the figure recommended by the WHO.

• Almost one in 3 pregnant women in Ireland give birth by c-section
• NewsTalk, 21 Feb 2017
• Almost one in 3 pregnant women in Ireland give birth by c-section. A new study from Trinity College and NUI Galway shows the rate has increased dramatically in the past few years. WHO

• Almost one in 3 pregnant women in Ireland give birth by c-section
• NewsTalk, 21 Feb 2017
• Women who had an elective caesarean section are being urged to encourage to have a natural birth if they having another child. Trinity College NUI Galway Europe

• A third of pregnant Irish women opt for c-sections
• Today FM, 21 Feb 2017
• Almost one in three pregnant women in Ireland have cesarean sections. A new study from Trinity College and NUI Galway shows that this rate has increased dramatically in the past few years and it is now more than double the figure recommended by the WHO. Trinity Professor Cecily Begley, who co-ordinated the project, says there are issues around c-sections that women are often not aware of.

• Study, Normal birth safer for women and babies than a Caesarean section.
• Today FM, 21 Feb 2017
• Normal birth is safer for women and babies than a Caesarean section. A new study from Trinity College and NUI Galway reveals that almost one in 3 pregnant women here have c-sections which rises to one in two for women in private care. Europe Prof. Cecily Begley, Study Co-ordinator

• Normal Birth is safer for Women and babies than a Caesarean section
• Today FM, 21 Feb 2017
• Normal Birth is safer for Women and babies than a Caesarean section. A New Study from Trinity College and NUI Galway reveals almost one in 3 pregnant women here have C-Sections, which rises to one in two for women in Private care.

• Shannonside Northern Sound radio – 22nd February
• Tipp FM radio – 22nd February
• Clare FM radio – 22nd February
• South East radio – 21st February

List of Websites:
Co-ordinator’s contact details: Professor Cecily Begley, Trinity College Dublin, 24 D’Olier St, Dublin 2, Ireland cbegley@tcd.ie

Project public website http://www.optibirth.eu/optibirth/ In the first few months following the end of the project, the website will move to a new permanent home on the website of the School of Nursing and Midwifery, Trinity College Dublin, at the following url http://www.nursing-midwifery.tcd.ie/OptiBIRTH/

Related information

Reported by

THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN
Ireland
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