| 1. |
- Fobelets, M., et al.
(author)
-
Health economic analysis of a cluster-randomised trial (OptiBIRTH) designed to increase rates of vaginal birth after caesarean section
- 2019
-
In: BJOG: An International Journal of Obstetrics and Gynaecology. - : Wiley. - 1470-0328 .- 1471-0528. ; 126:8, s. 1043-1051
-
Journal article (peer-reviewed)abstract
- Objective: To perform a health economic analysis of an intervention designed to increase rates of vaginal birth after caesarean, compared with usual care. Design: Economic analysis alongside the cluster-randomised OptiBIRTH trial (Optimising childbirth by increasing vaginal birth after caesarean section (VBAC) through enhanced women-centred care). Setting: Fifteen maternity units in three European countries – Germany (five), Ireland (five), and Italy (five) – with relatively low VBAC rates. Population: Pregnant women with a history of one previous lower-segment caesarean section; sites were randomised (3:2) to intervention or control. Methods: A cost–utility analysis from both societal and health-services perspectives, using a decision tree. Main outcome measures: Costs and resource use per woman and infant were compared between the control and intervention group by country, from pregnancy recognition until 3months postpartum. Based on the caesarean section rates, and maternal and neonatal morbidities and mortality, the incremental cost–utility ratios were calculated per country. Results: The mean difference in costs per quality-adjusted life years (QALYs) gained from a societal perspective between the intervention and the control group, using a probabilistic sensitivity analysis, was: €263 (95%CI €258–268) and 0.008QALYs (95%CI 0.008–0.009QALYs) for Germany, €456 (95%CI €448–464) and 0.052QALYs (95%CI 0.051–0.053QALYs) for Ireland, and €1174 (95%CI €1170–1178) and 0.006QALYs (95%CI 0.005–0.007 QALYs) for Italy. The incremental cost–utility ratios were €33,741/QALY for Germany, €8785/QALY for Ireland, and €214,318/QALY for Italy, with a 51% probability of being cost-effective for Germany, 92% for Ireland, and 15% for Italy. Conclusion: The OptiBIRTH intervention was likely to be cost-effective in Ireland and Germany. Tweetable abstract: The OptiBIRTH intervention (to increase VBAC rates) is likely to be cost-effective in Germany and Ireland. © 2019 Royal College of Obstetricians and Gynaecologists
|
|
| 2. |
- Fobelets, M., et al.
(author)
-
Preference of birth mode and postnatal health related quality of life after one previous caesarean section in three European countries
- 2019
-
In: Midwifery. - : Elsevier BV. - 0266-6138. ; 79
-
Journal article (peer-reviewed)abstract
- 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. © 2019 Elsevier Ltd
|
|
| 3. |
- Healy, P., et al.
(author)
-
Process evaluation for OptiBIRTH, a randomised controlled trial of a complex intervention designed to increase rates of vaginal birth after caesarean section
- 2018
-
In: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 19
-
Journal article (peer-reviewed)abstract
- 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.
|
|
| 4. |
- Begley, Cecily, 1954, et al.
(author)
-
Outcome measures in studies on the use of oxytocin for the treatment of delay in labour: A systematic review
- 2014
-
In: Midwifery. - : Elsevier BV. - 0266-6138. ; 30:9, s. 975-982
-
Research review (peer-reviewed)abstract
- Objectives: to identify primary and secondary outcome measures in randomised trials, and systematic reviews of randomised trials, measuring effectiveness of oxytocin for treatment of delay in the first and second stages of labour, and to identify any positive health-focussed outcomes used. Design: eight relevant citation databases were searched up to January 2013 for all randomised trials, and systematic reviews of randomised trials, measuring effectiveness of oxytocin for treatment of delay in labour. Trials of active management of labour or partogram action lines were excluded. 1918 citations were identified. Two reviewers reviewed all citations and extracted data. Twenty-six individual trials and five systematic reviews were included. Primary and secondary outcome measures were documented and analysed using frequency distributions. Findings: most frequent primary outcomes were caesarean section (n=15, 46%), length of labour (n=14, 42%), measurements of uterine activity (n=13, 39%) and mode of vaginal birth (n=9, 27%). Maternal satisfaction was identified a priori by one review and included as a secondary outcome by three papers. No further positive health-focussed outcomes were identified. Key conclusions: outcomes used to measure the effectiveness of oxytocin for treatment of delay in labour are heterogeneous and tend to focus on adverse events. Implications for practice: it is recommended that, in future randomised trials of oxytocin use for delay in labour, some women-centred and health-focussed outcome measures should be used, which may instil a more salutogenic culture in childbirth. © 2014 The Authors.
|
|
| 5. |
|
|
| 6. |
|
|
| 7. |
|
|
| 8. |
- Nilsson, Christina, 1959, et al.
(author)
-
Women-centred interventions to increase vaginal birth after caesarean section (VBAC): A systematic review
- 2015
-
In: Midwifery. - : Elsevier BV. - 0266-6138 .- 1532-3099. ; 31:7, s. 657-663
-
Journal article (peer-reviewed)abstract
- 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. (C) 2015 Elsevier Ltd. All rights reserved.
|
|
| 9. |
|
|
