| 1. |
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| 2. |
- Begley, Cecily, 1954, et al.
(författare)
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Evaluation of an intervention to increase vaginal birth after caesarean section through enhanced women-centred care: The OptiBIRTH randomised trial (ISRCTN10612254)
- 2017
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Ingår i: 31th ICM Triennial Congress.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Background: Vaginal birth after a previous caesarean (VBAC) is a safe alternative to repeat caesarean section (CS), is the preferred option of most women and may reduce overall CS rates.1 However, VBAC rates vary; e.g., rates in Germany, Ireland and Italy are considerably lower (29-36%) than those in the Netherlands, Sweden and Finland (45-55%). Purpose/Objective: To evaluate the effectiveness of an intervention to maximise VBAC rates. The OptiBIRTH Project was funded by a European Union Grant: FP7-HEALTH-2012-INNOVATION-1-HEALTH.2012.3.2-1. Agreement No:305208 Method: A cluster randomised trial was used. A sample size of 12 maternity units was required, each recruiting 120 consenting women, to detect an absolute 15% difference in successful VBACs (increase from 25% in control to 40% in intervention groups), using an ICC of 0.05, with power of >80% and an alpha of 0.05. To allow for loss to follow-up, 15 trial units were randomised across three countries with low VBAC rates (Germany, Ireland and Italy) and the trial commenced April 2014. An evidence-based intervention was introduced in all intervention sites. Control sites had usual care. Interim analysis by an independent Data Monitoring Committee at mid-point permitted continuation. Data were analysed using intention to treat. Key Findings: Recruitment closed October 2015, with the last babies born in December 2015, and data analysis will be completed in April 2016. The primary outcome, comparison of annual VBAC rates for each hospital before and after introduction of the intervention will be presented, and selected secondary outcomes for the recruited women including: mode of birth, perineal trauma, breastfeeding, uterine rupture, wound breakdown, perinatal mortality, Apgar scores, and admission to neonatal intensive care unit. Discussion: If the OptiBIRTH intervention increases VBAC rates safely, its introduction across Europe could prevent 160,000 unnecessary CSs every year, saving maternity services >€150 million annually and contributing to the normalisation of birth for thousands of women. References: 1 Cunningham et al (2010). National Institute of Health Consensus Development Conference Statement: Vaginal birth after caesarean. Obstet & Gynecol 115(6): 1279-1295. 2 EURO-PERISTAT 2008: CD006066.EURO-PERISTAT Project (2008). European Perinatal Health Report. (www.europeristat.com).
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| 3. |
- Clarke, Mike, et al.
(författare)
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OptiBIRTH: a cluster randomised trial of acomplex intervention to increase vaginalbirth after caesarean section
- 2020
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Ingår i: BMC Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393 .- 1471-2393.
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Tidskriftsartikel (refereegranskat)abstract
- Background: Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are lowin many countries.Methods: OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC ratesthrough an unblinded cluster randomised trial in 15 maternity units with VBAC rates < 35% in Germany, Ireland andItaly. Sites were matched in pairs or triplets based on annual birth numbers and VBAC rate, and randomised, 1:1 or 2:1, intervention versus control, following trial registration. The intervention involved evidence-based education ofclinicians and women with one previous caesarean section (CS), appointment of opinion leaders, audit/peer review,and joint discussions by women and clinicians. Control sites provided usual care. Primary outcome was annualhospital-level VBAC rates before the trial (2012) versus final year of the trial (2016). Between April 2014 and October2015, 2002 women were recruited (intervention 1195, control 807), with mode-of-birth data available for 1940women.Results: The OptiBIRTH intervention was feasible and safe across hospital settings in three countries. There was nostatistically significant difference in the change in the proportion of women having a VBAC between interventionsites (25.6% in 2012 to 25.1% in 2016) and control sites (18.3 to 22.3%) (odds ratio adjusted for differences betweenintervention and control groups (2012) and for homogeneity in VBAC rates at sites in the countries: 0.87, 95% CI:0.67, 1.14, p = 0.32 based on 5674 women (2012) and 5284 (2016) with outcome data. Among recruited womenwith birth data, 4/1147 perinatal deaths > 24 weeks gestation occurred in the intervention group (0.34%) and 4/782in the control group (0.51%), and two uterine ruptures (one per group), a rate of 1:1000.Conclusions: Changing clinical practice takes time. As elective repeat CS is the most common reason for CS inmultiparous women, interventions that are feasible and safe and that have been shown to lead to decreasingrepeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. Thismay best be done using an implementation science approach that can modify evidence-based interventions inresponse to changing clinical circumstances.Trial registration: The OptiBIRTH trial was registered on 3/4/2013. Trial registration number ISRCTN10612254.
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| 4. |
- Lundgren, Ingela, 1957, et al.
(författare)
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Clinician-centred interventions to increase vaginal birth after caesarean section (VBAC): a systematic review
- 2015
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Ingår i: BMC Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 15:16
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundThe 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.MethodsThe 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.Results238 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.ConclusionsThis 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.
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| 5. |
- Lundgren, Ingela, 1957, et al.
(författare)
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Clinicians views of factors of importance for improving the rate of vaginal births after caesarean section (VBAC) - A study from countries with high and low VBAC-rates
- 2014
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Ingår i: Optimising Childbirth Across Europe, 9-10 April 2014. Brussels, Belgium..
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Introduction: This study is a part of the ongoing 4-year OptiBIRTH project, which is funded by EU and involving eight European countries. The key aim of the project is to promote increased VBAC rates across Europe. Repeat caesarean section (CS) following previous CS is one of the most significant factors contributing to increased CS rates in the EU. Even though VBAC is the recommended option associated with better outcomes for both mothers and babies, vaginal birth rates after CS vary widely through healthcare settings and countries across Europe. It is important to obtain a deeper knowledge about clinician’s views on VBAC in different countries to understand important factors for improving VBAC rates. The findings of this study will assist in the development of educational interventions targeted towards both clinicians and women, and tested in an upcoming randomised trial in three European countries with low VBAC rates. Aim of the study: The aim with this study was to investigate clinicians’ views on important factors for improving the rate of VBAC in women. Research methodology: Individual interviews, telephone interviews and focus groups interviews with clinician’s (doctors and midwives as well as GPs in different maternity care settings and in rural and urban regions) have been conducted in six countries during 2012-2013; Finland, the Netherlands, Sweden (high VBAC rate), Ireland, Italy, Germany (low VBAC rate). In total about 115 clinicians were interviewed. They answered five questions about VBAC and participation in decision-making. The interviews were analysed using content analysis. Ethical approval: Approval was obtained from study sites in each country. Study findings and conclusions: Findings from this ongoing study will be presented at the congress under the domains: important factors for VBAC, barriers for VBAC, views on decision-making, and support for VBAC.
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| 6. |
- Lundgren, Ingela, 1957, et al.
(författare)
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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.
- 2016
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Ingår i: BMC Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393 .- 1471-2393. ; 16:1
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 7. |
- Lundgren, Ingela, 1957, et al.
(författare)
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How can the VBAC rates be improved – according to midwives and obstetricians in six European countries.
- 2017
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Ingår i: 31th ICM Trienníal Congress 18-22 June 2017.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Background: The most common reason for caesarean section (CS) is repeat CS following previous CS. Vaginal birth after CS (VBAC) rates vary widely in different healthcare settings and countries. Interview studies 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’, a research project funded by EU aiming to increase VBAC rates across Europe through enhanced woman-centred maternity care. Purpose/Objective: To investigate the views of clinicians on factors of importance for improving VBAC rates. Method: Individual interviews and focus group interviews with clinicians in six countries with high and low VBAC rates were conducted during 2012–2013. 115 clinicians participated: 61 midwives and 54 physicians. Five questions about VBAC were used and interviews were analysed using content analysis. The analysis was performed in each country in the native language, translated into English, analysed together, and finally categories were validated in each country. Key Findings: According to midwives and obstetricians from countries with high VBAC rates, the important factors for improving the VBAC rate are a common approach, obstetricians’ final decision on the mode of birth, support during birth, and the strengthening of women’s trust in VBAC. Therefore the structure of the maternity care system in the country, cooperation between midwives and obstetricians, and the care offered during pregnancy and birth should be focused. Findings from the low VBAC countries will be presented at the conference and shows similarities in some aspects but also major differences. Discussion: Similarities and differences between factors of importance for improving the VBAC rate are related to both the care structure, and the views and attitudes of midwives and physicians, which has implications for the care of women post CS.
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| 8. |
- Morano, Sandra, et al.
(författare)
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Emotions in labour: Italian obstetricians’ experiences of presence during childbirth
- 2018
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Ingår i: Journal of Reproductive and Infant Psychology. - : Informa UK Limited. - 0264-6838 .- 1469-672X. ; 36:1, s. 30-41
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The present study represents a qualitative research aimed to explore the obstetricians’ psychological experiences of birth. Background: During labour the role of obstetricians assumes a fundamental importance in hospitalised childbirth. However, literature analysis has shown that the psychological side of birth has been investigated only considering the woman’s and midwife’s points of view. The obstetricians’ psychological experiences have not been considered enough and only a few studies at a quantitative level have been performed. Methods: Seven focus groups for a total of 72 obstetricians were conducted in hospital contexts in Italy. The qualitative methodology of grounded theory was adopted. Findings: The results were divided into three different core themes: obstetricians’ approaches to delivery, critical aspects about relationships in the delivery room, and obstetricians’ feelings and emotions in the delivery room. Each theme was subdivided into different subthemes. Conclusion: The results highlight different ways obstetricians approach their profession, the complex and multifaceted relationship with the woman and the extraordinary variety of feelings and emotions, which enrich, but also may complicate, life in the delivery room. Further studies could provide more details to help researchers to develop new and more effective strategies to support obstetricians’ training and work.
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| 9. |
- Nicoletti, Paola, et al.
(författare)
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Association of Liver Injury From Specific Drugs, or Groups of Drugs, With Polymorphisms in HLA and Other Genes in a Genome-Wide Association Study
- 2017
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Ingår i: Gastroenterology. - : W B SAUNDERS CO-ELSEVIER INC. - 0016-5085 .- 1528-0012. ; 152:5, s. 1078-1089
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND & AIMS: We performed a genome-wide association study (GWAS) to identify genetic risk factors for druginduced liver injury (DILI) from licensed drugs without previously reported genetic risk factors. METHODS: We performed a GWAS of 862 persons with DILI and 10,588 population-matched controls. The first set of cases was recruited before May 2009 in Europe (n = 137) and the United States (n = 274). The second set of cases were identified from May 2009 through May 2013 from international collaborative studies performed in Europe, the United States, and South America. For the GWAS, we included only cases with patients of European ancestry associated with a particular drug (but not flucloxacillin or amoxicillin-clavulanate). We used DNA samples from all subjects to analyze HLA genes and single nucleotide polymorphisms. After the discovery analysis was concluded, we validated our findings using data from 283 European patients with diagnosis of DILI associated with various drugs. RESULTS: We associated DILI with rs114577328 (a proxy for A* 33: 01 a HLA class I allele; odds ratio [OR], 2.7; 95% confidence interval [CI], 1.9 - 3.8; P = 2.4 x 10(-8)) and with rs72631567 on chromosome 2 (OR, 2.0; 95% CI, 1.6 - 2.5; P = 9.7 x 10(-9)). The association with A* 33: 01 was mediated by large effects for terbinafine-, fenofibrate-, and ticlopidine-related DILI. The variant on chromosome 2 was associated with DILI from a variety of drugs. Further phenotypic analysis indicated that the association between DILI and A* 33: 01 was significant genome wide for cholestatic and mixed DILI, but not for hepatocellular DILI; the polymorphism on chromosome 2 was associated with cholestatic and mixed DILI as well as hepatocellular DILI. We identified an association between rs28521457 (within the lipopolysaccharide-responsive vesicle trafficking, beach and anchor containing gene) and only hepatocellular DILI (OR, 2.1; 95% CI, 1.6 - 2.7; P = 4.8 x 10(-9)). We did not associate any specific drug classes with genetic polymorphisms, except for statin-associated DILI, which was associated with rs116561224 on chromosome 18 (OR, 5.4; 95% CI, 3.0 - 9.5; P = 7.1 x 10(-9)). We validated the association between A* 33: 01 terbinafine-and sertraline-induced DILI. We could not validate the association between DILI and rs72631567, rs28521457, or rs116561224. CONCLUSIONS: In a GWAS of persons of European descent with DILI, we associated HLA-A* 33: 01 with DILI due to terbinafine and possibly fenofibrate and ticlopidine. We identified polymorphisms that appear to be associated with DILI from statins, as well as 2 non-drug-specific risk factors.
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| 10. |
- Nicoletti, Paola, et al.
(författare)
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Drug-Induced Liver Injury due to Flucloxacillin : Relevance of Multiple Human Leukocyte Antigen Alleles
- 2019
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Ingår i: Clinical Pharmacology and Therapeutics. - : John Wiley & Sons. - 0009-9236 .- 1532-6535. ; 106:1, s. 245-253
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Tidskriftsartikel (refereegranskat)abstract
- Some patients prescribed flucloxacillin (similar to 0.01%) develop drug-induced liver injury (DILI). HLA-B*57:01 is an established genetic risk factor for flucloxacillin DILI. To consolidate this finding, identify additional genetic factors, and assess relevance of risk factors for flucloxacillin DILI in relation to DILI due to other penicillins, we performed a genomewide association study involving 197 flucloxacillin DILI cases and 6,835 controls. We imputed single-nucleotide polymorphism and human leukocyte antigen (HLA) genotypes. HLA-B*57:01 was the major risk factor (allelic odds ratio (OR) = 36.62; P = 2.67 x 10(-97)). HLA-B*57:03 also showed an association (OR = 79.21; P = 1.2 x 10(-6)). Within the HLA-B protein sequence, imputation showed valine(97), common to HLA-B*57:01 and HLA-B*57:03, had the largest effect (OR = 38.1; P = 9.7 x 10(-97)). We found no HLA-B*57 association with DILI due to other isoxazolyl penicillins (n = 6) or amoxicillin (n = 15) and no significant non-HLA signals for any penicillin-related DILI.
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