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

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.

Mode of birth and postnatal health-related quality of life after one previous cesarean in three European countries.

BACKGROUND: How a woman gives birth can affect her health-related quality of life (HRQoL). This study explored HRQoL at 3 months postpartum in women with a history of one previous cesarean in three European countries. METHODS: A prospective longitudinal survey, embedded within a cluster randomized trial in three countries, exploring women's postnatal HRQoL up to 3 months postpartum. The Short-Form Six-Dimensions (SF-6D) was used to measure HRQoL, and multivariate analyses were used to examine the relationship with mode of birth. RESULTS: Complete data were available from 880 women. Women with a spontaneous vaginal birth had the highest HRQoL scores, whereas women with an emergency repeat cesarean (P = .01) had the lowest. Postnatal readmission of the mother (P = .03), having public health insurance (P = .04), and a low antenatal HRQoL score (P < .01) contributes to poorer HRQoL scores. More specifically, women with a spontaneous vaginal birth had significantly higher HRQoL scores on the vitality dimension compared with women with an emergency repeat cesarean (P = .04). CONCLUSIONS: In women with low-risk factors, repeat cesareans result in a poorer HRQoL compared with vaginal birth. When there are no contraindications for vaginal birth, women with a history of one previous cesarean should be encouraged to give birth vaginally rather than have an elective repeat cesarean.

Clinicians' views of factors of importance for improving the rate of VBAC (vaginal birth after caesarean section): a study from countries with low VBAC rates.

BACKGROUND: Caesarean section (CS) rates are increasing worldwide and the most common reason is repeat CS following previous CS. For most women a vaginal birth after a previous CS (VBAC) is a safe option. However, the rate of VBAC differs in an international perspective. Obtaining deeper knowledge of clinicians' views on VBAC can help in understanding the factors of importance for increasing VBAC rates. Focus group interviews with clinicians and women in three countries with high VBAC rates (Finland, Sweden and the Netherlands) and three countries with low VBAC rates (Ireland, Italy and Germany) are part of "OptiBIRTH", an ongoing research project. The study reported here aims to explore the views of clinicians from countries with low VBAC rates on factors of importance for improving VBAC rates. METHODS: Focus group interviews were held in Ireland, Italy and Germany. In total 71 clinicians participated in nine focus group interviews. Five central questions about VBAC were used and interviews were analysed using content analysis. The analysis was performed in each country in the native language and then translated into English. All data were then analysed together and final categories were validated in each country. RESULTS: The findings are presented in four main categories with several sub-categories: 1) "prameters for VBAC", including the importance of the obstetric history, present obstetric factors, a positive attitude among those who are centrally involved, early follow-up after CS and antenatal classes; 2) "organisational support and resources for women undergoing a VBAC", meaning a successful VBAC requires clinical expertise and resources during labour; 3) "fear as a key inhibitor of successful VBAC", including understanding women's fear of childbirth, clinicians' fear of VBAC and the ways that clinicians' fear can be transferred to women; and 4) "shared decision making - rapport, knowledge and confidence", meaning ensuring consistent, realistic and unbiased information and developing trust within the clinician-woman relationship. CONCLUSIONS: The findings indicate that increasing the VBAC rate depends on organisational factors, the care offered during pregnancy and childbirth, the decision-making process and the strategies employed to reduce fear in all involved.

Clinician-centred interventions to increase vaginal birth after caesarean section (VBAC): a systematic review.

BACKGROUND: The number of caesarean sections (CS) is increasing globally, and repeat CS after a previous CS is a significant contributor to the overall CS rate. Vaginal birth after caesarean (VBAC) can be seen as a real and viable option for most women with previous CS. To achieve success, however, women need the support of their clinicians (obstetricians and midwives). The aim of this study was to evaluate clinician-centred interventions designed to increase the rate of VBAC. METHODS: The bibliographic databases of The Cochrane Library, PubMed, PsychINFO and CINAHL were searched for randomised controlled trials, including cluster randomised trials that evaluated the effectiveness of any intervention targeted directly at clinicians aimed at increasing VBAC rates. Included studies were appraised independently by two reviewers. Data were extracted independently by three reviewers. The quality of the included studies was assessed using the quality assessment tool, 'Effective Public Health Practice Project'. The primary outcome measure was VBAC rates. RESULTS: 238 citations were screened, 255 were excluded by title and abstract. 11 full-text papers were reviewed; eight were excluded, resulting in three included papers. One study evaluated the effectiveness of antepartum x-ray pelvimetry (XRP) in 306 women with one previous CS. One study evaluated the effects of external peer review on CS birth in 45 hospitals, and the third evaluated opinion leader education and audit and feedback in 16 hospitals. The use of external peer review, audit and feedback had no significant effect on VBAC rates. An educational strategy delivered by an opinion leader significantly increased VBAC rates. The use of XRP significantly increased CS rates. CONCLUSIONS: This systematic review indicates that few studies have evaluated the effects of clinician-centred interventions on VBAC rates, and interventions are of varying types which limited the ability to meta-analyse data. A further limitation is that the included studies were performed during the late 1980s-1990s. An opinion leader educational strategy confers benefit for increasing VBAC rates. This strategy should be further studied in different maternity care settings and with professionals other than physicians only.

Labour characteristics of women achieving successful vaginal birth after caesarean section in three European countries.

OBJECTIVE: Knowledge about labour characteristics of women achieving successful vaginal birth after caesarean section (VBAC) might be used to improve labour and birth management. This study examined sociodemographic and labour process-related factors regarding a) differences between countries, b) the comparison of successful VBAC with unplanned caesarean section, and c) predictors for the success of planned VBAC in three European countries. DESIGN: We analysed observational data collected within the OptiBIRTH trial, a cluster-randomised controlled trial. SETTING: Fifteen study sites in Ireland, Italy and Germany, five in each country. PARTICIPANTS: 790 participants going into labour for planned VBAC. MEASUREMENTS: Descriptive statistics and random-effects logistic regression models were applied. FINDINGS: The pooled successful VBAC-rate was 74.6%. Italy had the highest proportion of women receiving none of the four intrapartum interventions amniotomy (ARM), oxytocin, epidural or opioids (42.5% vs Ireland: 26.8% and Germany: 25.3%, p < 0.001). Earlier performance of ARM was associated with successful VBAC (3.50 hrs vs 6.08 hrs, p = 0.004). A positive predictor for successful vaginal birth was a previous vaginal birth (OR=3.73, 95% CI [2.17, 6.44], p < 0.001). The effect of ARM increased with longer labour duration (OR for interaction term=1.06, 95% CI [1.004, 1.12], p = 0.035). Higher infant birthweight (OR per kg=0.34, 95% CI [0.23, 0.50], p < 0.001), ARM (reference spontaneous rupture of membranes (SROM), OR=0.20, 95% CI [0.11, 0.37], p < 0.001) and a longer labour duration (OR per hour=0.93, 95% CI [0.90, 0.97], p < 0.001) decreased the odds of a vaginal birth. KEY CONCLUSION: Women with a previous vaginal birth, an infant with a lower birth weight, SROM and a shorter labour duration were most likely to have a successful vaginal birth. If SROM did not occur, an earlier ARM increased the odds of a vaginal birth. IMPLICATION FOR PRACTICE: Labour progress should be accelerated by fostering endogenous uterine contractions. With slow labour progress and intact membranes, ARM might increase the chance of a vaginal birth.

Preference of birth mode and postnatal health related quality of life after one previous caesarean section in three European countries.

OBJECTIVES: Women who have had a caesarean section may have a preference for birth mode during their subsequent pregnancy, either 'vaginal birth after caesarean' (VBAC) or 'elective repeat caesarean section' (ERCS). A mismatch between the preferred and actual birth mode may result in an impaired postnatal Health Related Quality of Life (HRQoL). This study examined the associations between antenatal birth mode preferences, the actual birth mode and postnatal HRQoL in women with one previous caesarean section in three European countries. DESIGN: Prospective longitudinal survey, as a part of a cluster randomised trial (OptiBIRTH) SETTING: Fifteen maternity units in three European countries: Germany (5), Ireland (5) and Italy (5). PARTICIPANTS: Women (≥ aged 18 years) living in Germany, Ireland and Italy with one previous caesarean section. The sample consisted of 862 women with complete antenatal and postpartum data. MEASUREMENTS: Women's preference for birth mode after one previous caesarean section was assessed at inclusion to the trial, and HRQoL was assessed antenatally and at three months postpartum using the Short-Form Six-Dimension health survey. Based on women's preferences and actual birth mode six groups were determined: "match VBAC-VBAC" (preference for vaginal birth, actual mode of birth vaginal birth), "match ERCS-ERCS" (preference for caesarean section, actual mode of birth elective repeat caesarean section), "match ERCS-EMCS" (preference for caesarean section, actual mode of birth emergency repeat caesarean section), "mismatch VBAC-ERCS" (preference for vaginal birth, actual mode of birth elective repeat caesarean section), "mismatch VBAC-EMCS" (preference for vaginal birth, actual mode of birth emergency repeat caesarean section) and "no preference". Associations between the preferred and actual birth mode were examined using univariate and multivariate analyses. FINDINGS: Women with preference for vaginal birth but who gave birth by elective repeat caesarean section (mismatch VBAC-ERCS) had a lower postnatal HRQoL compared to women with a preference for vaginal birth who actually had a birth vaginally (match VBAC-VBAC, p = 0.02). Poor antenatal HRQoL scores (p < 0.01) and maternal readmission postpartum (p = 0.03) are cofounding factors for poorer postnatal HRQoL scores. KEY CONCLUSIONS: The results show that women with a preference for a vaginal birth who gave birth by an elective repeat caesarean section had a significantly lower HRQoL at three months postnatal. The long-term consequences and psychological health of women who do not achieve a vaginal birth after caesarean require further consideration and research. IMPLICATIONS FOR PRACTICE: Attention should be given to the long-term impact of a mismatch in preferred and actual mode on the psychological health of women.

Process evaluation for OptiBIRTH, a randomised controlled trial of a complex intervention designed to increase rates of vaginal birth after caesarean section.

BACKGROUND: Complex interventions encompassing several interconnecting and interacting components can be challenging to evaluate. Examining the underlying trial processes while an intervention is being tested can assist in explaining why an intervention was effective (or not). This paper describes a process evaluation of a pan-European cluster randomised controlled trial, OptiBIRTH (undertaken in Ireland, Italy and Germany), that successfully used both quantitative and qualitative methods to enhance understanding of the underlying trial mechanisms and their effect on the trial outcome. METHODS: We carried out a mixed methods process evaluation. Quantitative and qualitative data were collected from observation of the implementation of the intervention in practice to determine whether it was delivered according to the original protocol. Data were examined to assess the delivery of the various components of the intervention and the receipt of the intervention by key stakeholders (pregnant women, midwives, obstetricians). Using ethnography, an exploration of perceived experiences from a range of recipients was conducted to understand the perspective of both those delivering and those receiving the intervention. RESULTS: Engagement by stakeholders with the different components of the intervention varied from minimal intensity of women's engagement with antenatal classes, to moderate intensity of engagement with online resources, to high intensity of clinicians' exposure to the education sessions provided. The ethnography determined that, although the overall culture in the intervention site did not change, smaller, more individual cultural changes were observed. The fidelity of the delivery of the intervention scored average quality marks of 80% and above on repeat assessments. CONCLUSION: Nesting a process evaluation within the trial enabled the observation of the mode of action of the intervention in its practice context and ensured that the intervention was delivered with a good level of consistency. Implementation problems were identified as they arose and were addressed accordingly. When dealing with a complex intervention, collecting and analysing both quantitative and qualitative data, as we did, can greatly enhance the process evaluation. TRIAL REGISTRATION: Current Controlled Trials Register, ISRCTN10612254 . Registered on 3 April 2013.

Vaginal birth after caesarean: Views of women from countries with low VBAC rates.

PROBLEM AND BACKGROUND: Vaginal birth after caesarean section is a safe option for the majority of women. Seeking women's views can be of help in understanding factors of importance for achieving vaginal birth in countries where the vaginal birth rates after caesarean is low. AIM: To investigate women's views on important factors to improve the rate of vaginal birth after caesareanin countries where vaginal birth rates after previous caesarean are low. METHODS: A qualitative study using content analysis. Data were gathered through focus groups and individual interviews with 51 women, in their native languages, in Germany, Ireland and Italy. The women were asked five questions about vaginal birth after caesarean. Data were translated to English, analysed together and finally validated in each country. FINDINGS: Important factors for the women were that all involved in caring for them were of the same opinion about vaginal birth after caesarean, that they experience shared decision-making with clinicians supportive of vaginal birth, receive correct information, are sufficiently prepared for a vaginal birth, and experience a culture that supports vaginal birth after caesarean. DISCUSSION AND CONCLUSION: Women's decision-making about vaginal birth after caesarean in these countries involves a complex, multidimensional interplay of medical, psychosocial, cultural, personal and practical considerations. Further research is needed to explore if the information deficit women report negatively affects their ability to make informed choices, and to understand what matters most to women when making decisions about vaginal birth after a previous caesarean as a mode of birth.

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).

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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10612254 , registered 3 April 2013.

Women-centred interventions to increase vaginal birth after caesarean section (VBAC): A systematic review.

OBJECTIVE: to evaluate the effectiveness of women-centred interventions during pregnancy and birth to increase rates of vaginal birth after caesarean. DESIGN: we searched bibliographic databases for randomised trials or cluster randomised trials on women-centred interventions during pregnancy and birth designed to increase VBAC rates in women with at least one previous caesarean section. Comparator groups included standard or usual care or an alternative treatment aimed at increasing VBAC rates. The methodological quality of included studies was assessed independently by two authors using the Effective Public Health Practice Project quality assessment tool. Outcome data were extracted independently from each included study by two review authors. FINDINGS: in total, 821 citations were identified and screened by title and abstract; 806 were excluded and full text of 15 assessed. Of these, 12 were excluded leaving three papers included in the review. Two studies evaluated the effectiveness of decision aids for mode of birth and one evaluated the effectiveness of an antenatal education programme. The findings demonstrate that neither the use of decision aids nor information/education of women have a significant effect on VBAC rates. Nevertheless, decision-aids significantly decrease women's decisional conflict about mode of birth, and information programmes significantly increase their knowledge about the risks and benefits of possible modes of birth. KEY CONCLUSIONS: few studies evaluated women-centred interventions designed to improve VBAC rates, and all interventions were applied in pregnancy only, none during the birth. There is an urgent need to develop and evaluate the effectiveness of all types of women-centred interventions during pregnancy and birth, designed to improve VBAC rates. IMPLICATIONS FOR PRACTICE: decision-aids and information programmes during pregnancy should be provided for women as, even though they do not affect the rate of VBAC, they decrease women's decisional conflict and increase their knowledge about possible modes of birth.