OptiBIRTH: a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section.
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SUBMITTER: Clarke M
PROVIDER: S-EPMC7059398 | biostudies-literature | 2020 Mar
REPOSITORIES: biostudies-literature
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OptiBIRTH: a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section.
Clarke Mike M Devane Declan D Gross Mechthild M MM Morano Sandra S Lundgren Ingela I Sinclair Marlene M Putman Koen K Beech Beverley B Vehviläinen-Julkunen Katri K Nieuwenhuijze Marianne M Wiseman Hugh H Smith Valerie V Daly Deirdre D Savage Gerard G Newell John J Simpkin Andrew A Grylka-Baeschlin Susanne S Healy Patricia P Nicoletti Jane J Lalor Joan J Carroll Margaret M van Limbeek Evelien E Nilsson Christina C Stockdale Janine J Fobelets Maaike M Begley Cecily C
BMC pregnancy and childbirth 20200306 1
<h4>Background</h4>Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are low in many countries.<h4>Methods</h4>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 ...[more]
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Project description:ObjectiveTo compare outcomes at 3 months post partum for women randomised to give birth by planned caesarean section (CS) or by planned vaginal birth (VB) in the Twin Birth Study (TBS).DesignWe invited women in the TBS to complete a 3-month follow-up questionnaire.SettingTwo thousand and eight hundred and four women from 25 countries.PopulationTwo thousand and five hundred and seventy women (92% response rate).MethodsWomen randomised between 13 December 2003 and 4 April 2011 in the TBS completed a questionnaire and outcomes were compared using an intention-to-treat approach.Main outcome and measuresBreastfeeding, quality of life, depression, fatigue and urinary incontinence.ResultsWe found no clinically important differences between groups in any outcome. In the planned CS versus planned VB groups, breastfeeding at any time after birth was reported by 84.4% versus 86.4% (P = 0.13); the mean physical and mental Short Form (36) Health Survey (SF-36) quality of life scores were 51.8 versus 51.6 (P = 0.65) and 46.7 versus 46.0 (P = 0.09), respectively; the mean Multidimensional Assessment of Fatigue score was 20.3 versus 20.8 (P = 0.14); the frequency of probable depression on the Edinburgh Postnatal Depression Scale was 14.0% versus 14.8% (P = 0.57); the rate of problematic urinary incontinence was 5.5% versus 6.4% (P = 0.31); and the mean Incontinence Impact Questionnaire-7 score was 20.5 versus 20.4 (P = 0.99). Partner relationships, including painful intercourse, were similar between the groups.ConclusionFor women with twin pregnancies randomised to planned CS compared with planned VB, outcomes at 3 months post partum did not differ. The mode of birth was not associated with problematic urinary incontinence or urinary incontinence that affected the quality of life. Contrary to previous studies, breastfeeding at 3 months was not increased with planned VB.Tweetable abstractPlanned mode of birth for twins doesn't affect maternal depression, wellbeing, incontinence or breastfeeding.
| S-EPMC5014197 | biostudies-literature
Project description:BACKGROUND: Uncertainty exists about benefits and harms of a planned vaginal birth after caesarean (VBAC) compared with elective repeat caesarean (ERC). We conducted a prospective restricted cohort study consisting of a patient preference cohort study, and a small nested randomised trial to compare benefits and risks of a planned ERC with planned VBAC. METHODS AND FINDINGS: 2,345 women with one prior caesarean, eligible for VBAC at term, were recruited from 14 Australian maternity hospitals. Women were assigned by patient preference (n = 2,323) or randomisation (n = 22) to planned VBAC (1,225 patient preference, 12 randomised) or planned ERC (1,098 patient preference, ten randomised). The primary outcome was risk of fetal death or death of liveborn infant before discharge or serious infant outcome. Data were analysed for the 2,345 women (100%) and infants enrolled. The risk of fetal death or liveborn infant death prior to discharge or serious infant outcome was significantly lower for infants born in the planned ERC group compared with infants in the planned VBAC group (0.9% versus 2.4%; relative risk [RR] 0.39; 95% CI 0.19-0.80; number needed to treat to benefit 66; 95% CI 40-200). Fewer women in the planned ERC group compared with women in the planned VBAC had a major haemorrhage (blood loss ? 1,500 ml and/or blood transfusion), (0.8% [9/1,108] versus 2.3% [29/1,237]; RR 0.37; 95% CI 0.17-0.80). CONCLUSIONS: Among women with one prior caesarean, planned ERC compared with planned VBAC was associated with a lower risk of fetal and infant death or serious infant outcome. The risk of major maternal haemorrhage was reduced with no increase in maternal or perinatal complications to time of hospital discharge. Women, clinicians, and policy makers can use this information to develop health advice and make decisions about care for women who have had a previous caesarean. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53974531
| S-EPMC3302845 | biostudies-literature
Project description:BackgroundBirth by caesarean section (CS) is associated with aberrant gut microbiome development and greater disease susceptibility later in life. We investigated whether oral administration of maternal vaginal microbiota to infants born by CS could restore their gut microbiome development in a pilot single-blinded, randomised placebo-controlled trial (Australian New Zealand Clinical Trials Registry, ACTRN12618000339257).MethodsPregnant women scheduled for a CS underwent comprehensive antenatal pathogen screening. At birth, healthy neonates were randomised to receive a 3 ml solution of either maternal vaginal microbes (CS-seeded, n = 12) or sterile water (CS-placebo, n = 13). Vaginally-born neonates were used as the reference control (VB, n = 22). Clinical assessments occurred within the first 2 h of birth, and at 1 month and 3 months of age. Infant stool samples and maternal vaginal extracts from CS women underwent shotgun metagenomic sequencing. The primary outcome was gut microbiome composition at 1 month of age. Secondary outcomes included maternal strain engraftment, functional potential of the gut microbiome, anthropometry, body composition, and adverse events.FindingsDespite the presence of viable microbial cells within transplant solutions, there were no observed differences in gut microbiome composition or functional potential between CS-seeded and CS-placebo infants at 1 month or 3 months of age. Both CS groups displayed the characteristic signature of low Bacteroides abundance, which contributed to a number of biosynthesis pathways being underrepresented when compared with VB microbiomes. Maternal vaginal strain engraftment was rare. Vaginal seeding had no observed effects on anthropometry or body composition. There were no serious adverse events associated with treatment.InterpretationOur pilot findings question the value of vaginal seeding given that oral administration of maternal vaginal microbiota did not alter early gut microbiome development in CS-born infants. The limited colonisation of maternal vaginal strains suggest that other maternal sources, such as the perianal area, may play a larger role in seeding the neonatal gut microbiome.FundingHealth Research Council of New Zealand, A Better Start - National Science Challenge.
| S-EPMC8254083 | biostudies-literature
Project description:BackgroundThe OptiBIRTH study incorporates a multicentre cluster randomised trial in 15 hospital sites across three European countries. The trial was designed to test a complex intervention aimed at improving vaginal birth after caesarean section (VBAC) rates through increasing women's involvement in their care. Prior to developing a robust standardised model to conduct the health economic analysis, an analysis of a hypothetical cohort was performed to estimate the costs and health effects of VBAC compared to elective repeat caesarean delivery (ERCD) for low-risk women in four European countries.MethodsA decision-analytic model was developed to estimate the costs and the health effects, measured using Quality Adjusted Life Years (QALYs), of VBAC compared with ERCD. A cost-effectiveness analysis for the period from confirmation of pregnancy to 6 weeks postpartum was performed for short-term consequences and during lifetime for long-term consequences, based on a hypothetical cohort of 100,000 pregnant women in each of four different countries; Belgium, Germany, Ireland and Italy. A societal perspective was adopted. Where possible, transition probabilities, costs and health effects were adapted from national data obtained from the respective countries. Country-specific thresholds were used to determine the cost-effectiveness of VBAC compared to ERCD. Deterministic and probabilistic sensitivity analyses were conducted to examine the uncertainty of model assumptions.ResultsWithin a 6-week time horizon, VBAC resulted in a reduction in costs, ranging from €3,334,052 (Germany) to €66,162,379 (Ireland), and gains in QALYs ranging from 6399 (Italy) to 7561 (Germany) per 100,000 women birthing in each country. Compared to ERCD, VBAC is the dominant strategy in all four countries. Applying a lifetime horizon, VBAC is dominant compared to ERCD in all countries except for Germany (probabilistic analysis, ICER: €8609/QALY). In conclusion, compared to ERCD, VBAC remains cost-effective when using a lifetime time.ConclusionsIn all four countries, VBAC was cost-effective compared to ERCD for low-risk women. This is important for health service managers, economists and policy makers concerned with maximising health benefits within limited and constrained resources.
| S-EPMC5896042 | biostudies-literature
Project description:IntroductionThough interest is growing for trials comparing planned delivery mode (vaginal delivery [VD]; cesarean section [CS]) in low-risk nulliparous women, appropriate study design is unclear. Our objective was to assess feasibility of three designs (preference trial [PCT], randomized controlled trial [RCT], partially randomized patient preference trial [PRPPT]) for a trial comparing planned delivery mode in low-risk women.MethodsA cross-sectional survey of low-risk, nulliparous pregnant women (N = 416) and healthcare providers (N = 168) providing prenatal care and/or labor/delivery services was conducted in Argentina (2 public, 2 private hospitals). Proportion of pregnant women and providers willing to participate in each design and reasons for not participating were determined.ResultsFew women (< 15%) or professionals (33.3%) would participate in an RCT, though more would participate in PCTs (88% women; 65.9% professionals) or PRPPTs (44.4% public, 63.4% private sector women; 44.0% professionals). However, most women would choose vaginal delivery in the PCT and PRPPT (> 85%). Believing randomization unacceptable (RCT, PRPPT) and desiring choice of delivery mode (RCT) were women's reasons for not participating. For providers, commonly cited reasons for not participating included unacceptability of performing CS without medical indication, difficulty obtaining informed consent, discomfort enrolling patients (all designs), and violating women's right to choose (RCT).Conclusions for practiceImportant limitations were found for each trial design evaluated. The necessity of stronger evidence regarding delivery mode in low-risk women suggests consideration of additional designs, such as a rigorously designed cohort study or an RCT within an obstetric population with equivocal CS indications.
| S-EPMC7922524 | biostudies-literature
Project description:OBJECTIVE:Does planned caesarean compared with planned vaginal birth lower the risk of problematic urinary stress, faecal, or flatal incontinence? DESIGN:Women between 320/7 and 386/7 weeks of gestation with a twin pregnancy were randomised to planned caesarean or planned vaginal birth. SETTING:The trial took place at 106 centres in 25 countries. POPULATION:A total of 2305 of the 2804 women enrolled in the study completed questionnaires at 2 years (82.2% follow-up): 1155 in the planned caesarean group and 1150 in the planned vaginal birth group. METHODS:A structured self-administered questionnaire completed at 2 years postpartum. MAIN OUTCOME MEASURES:The primary maternal outcome of the Twin Birth Study was problematic urinary stress, or fecal, or flatal incontinence at 2 years RESULTS: Women in the planned caesarean group had lower problematic urinary stress incontinence rates compared with women in the planned vaginal birth group [93/1147 (8.11%) versus 140/1143 (12.25%); odds ratio, 0.63; 95% confidence interval, 0.47-0.83; P = 0.001]. Among those with problematic urinary stress incontinence, quality of life (measured using the Incontinence Impact Questionnaire, IIQ-7) was not different for planned caesarean versus planned vaginal birth groups [mean (SD): 18.4 (21.0) versus 19.1 (21.5); P = 0.82]. There were no differences in problematic faecal or flatal incontinence, or in other maternal outcomes. CONCLUSIONS:Among women with a twin pregnancy and no prior history of urinary stress incontinence, a management strategy of planned caesarean compared with planned vaginal birth reduces the risk of problematic urinary stress incontinence at 2 years postpartum. Our findings show that the prevalence but not the severity of urinary stress incontinence was associated with mode of birth. FUNDING:Canadian Institutes of Health Research (CIHR) (grant no. MCT-63164). TWEETABLE ABSTRACT:For women with twins, planned caesarean compared with planned vaginal birth is associated with decreased prevalence but not severity of urinary stress incontinence at 2 years.
| S-EPMC6282843 | biostudies-other
Project description:Aims and objectivesThis research was conducted to explore the effectiveness of employing the healthcare failure mode and effect analysis method in the management of trial of labour after caesarean, with the aims of increasing vaginal birth after caesarean section rate and reducing potential risks that might cause severe complications.BackgroundPreviously high caesarean section rate in China and the "two children" policy leads to the situation where multiparas are faced with the choice of another caesarean or trial of labour after caesarean. Despite evidences showing the benefits of vaginal birth after caesarean, obstetricians and midwives in China tend to be conservative due to limited experience and insufficient clinical routines. Thus, its management needs further optimisation in order to make the practice safe and sound.DesignA prospective quality improvement programme using the healthcare failure mode and effect analysis.MethodsWith the structured methodology of healthcare failure mode and effect analysis, we determined core processes of antepartum and intrapartum management, conducted risk priority numbers and devised remedial protocols for failure modes with high risks. The programme was then implemented as a clinical routine under the agreement of the institutional review board and vaginal birth after caesarean success rates were compared before and after the quality improvement programme, both descriptively and statistically. Standards for Quality Improvement Reporting Excellence 2.0 checklist was chosen on reporting the study process.ResultsSeventy failure modes in seven core processes were identified in the management process, with 14 redressed for actions. The 1-year follow-up trial of labour after caesarean and vaginal birth after caesarean rate was increased compared with the previous 3 years, with a vaginal birth after caesarean rate of 86.36%, whereas the incidence of uterine rupture was not compromised.ConclusionsThe application of healthcare failure mode and effect analysis can not only promote trial of labour after caesarean and vaginal birth after caesarean rate, but also maintaining a low risk of uterine rupture.Relevance to clinical practiceThis modified vaginal birth after caesarean management protocol has been shown effective in increasing its successful rate, which can be continued for further comparison of severe complications to the previous practice.
| S-EPMC7328791 | biostudies-literature
Project description:IntroductionWith the wide adoption of the two-child policy in China since 2016, a large percentage of women with a history of caesarean delivery plan to have a second child. Accordingly, the rate of vaginal birth after caesarean (VBAC) delivery is increasing. Women attempting repeat VBAC may experience multiple morbidities, which is also one of the leading causes of maternal and perinatal mortality. However, it remains to be addressed how we evaluate factors for successful VBAC. This study aims to use a novel approach to identify a set of potential predictive factors for successful VBAC, especially for Chinese women, to be included in prediction models which can be most applicable to pregnant women in China. We plan to assess all potential predictive factors collected through a comprehensive literature review. Then the certainty of the evidence for the identified potential predictive factors will be assessed using the Grading of Recommendations Assessment, Development and Evaluation process. Finally, a two-round international Delphi survey will be conducted to determine the level of consensus.Methods and analysisThis study will apply a methodology through an evidence-based approach. A long list of potential predictive factors for successful VBAC will be extracted and identified through the following stages: First, an up-to-date systematic review of the published literature will be conducted to extract identified potential predictive factors for successful VBAC. Second, an online Delphi survey will be performed to achieve expert consensus on which factors should be included in future prediction models. The online questionnaires will be developed in the field of patient, maternal and fetal-related factors. A two-round international Delphi survey will be distributed to the expert panel in the field of perinatal medicine using Google Forms. Experts will be asked to score each factor using the 9-point Likert rating scale to establish potential predictive factors for the successful VBAC. The expert panel will determine on whether to include, potentially include or exclude predictive factors, based on a systematic review of clinical evidence and the Delphi method.Ethics and disseminationThe study was approved by the Institutional Review Board of the Jiaxing Maternity and Children Healthcare Hospital (approval number: 2019-79). The results of this study will be submitted to international peer-reviewed journals or conferences in perinatal medicine or obstetrics.
| S-EPMC8103394 | biostudies-literature
Project description:BackgroundIn the absence of medical necessity, opting for caesarean sections exposes mothers and neonates to increased risks of enduring long-term health problems and mortality. This ultimately results in greater economic burden when compared to the outcomes of spontaneous vaginal births. In Switzerland around 33% of all births are by caesarean section. However, the rate of caesarean sections without medical indication is still unknown. Therefore, we devise an identification strategy to differentiate caesarean sections without medical indication using routine data. In addition, we aim to categorize the influencing factors for women who undergo spontaneous vaginal births as opposed to those with caesarean sections without medical indication.MethodWe use Swiss Federal Statistics data including 98.3% of all women giving birth from 2014 to 2018. To determine non-medically indicated caesarean sections in our dataset, we base our identification strategy on diagnosis-related groups, diagnosis codes, and procedure classifications. Subsequently, we compare characteristics of women who give birth by non-medically CS and external factors such as the density of practicing midwives to women with spontaneous vaginal birth. Logistic regression analysis measures the effect of factors, such as age, insurance class, income, or density of practicing midwives on non-medically indicated caesarean sections.ResultsAround 8% of all Swiss caesarean sections have no medical indication. The regression analysis shows that higher age, supplemental insurance, higher income, and living in urban areas are associated with non-medically indicated caesarean sections, whereas a higher density of midwives decreases the likelihood of caesarean sections without medical indication.ConclusionsBy identifying non-medically indicated caesarean sections using routine data, it becomes feasible to gain insights into the characteristics of impacted mothers as well as the external factors involved. Illustrating these results, our recommendation is to revise the incentive policies directed towards healthcare professionals. Among others, future research may investigate the potential of midwife-assisted pregnancy programs on strengthening spontaneous vaginal births in absence of medical complications.
| S-EPMC10605562 | biostudies-literature
Project description:BackgroundVaginal birth after caesarean section (VBAC) is an alternative to a caesarean section (CS) in the absence of repeat or new indications for primary CS. There is a knowledge gap regarding the trend and successful VBAC in Ethiopia. Therefore this systematic review and meta-analysis aimed to assess the trend, pooled prevalence of successful VBAC and its predictors in Ethiopia.MethodsElectronic databases (SCOPUS, CINAHL, Embase, PubMed and Web of Science), Google Scholar and lists of references were used to search works of literature in Ethiopia. Stata version 14 was used for analysis and the odds ratios of the outcome variable were determined using the random effects model. Heterogeneity among the studies was assessed by computing values for I2 and p-values. Also, sensitivity analyses and funnel plots were done to assess the stability of pooled values to outliers and publication bias, respectively.ResultsA total of 12 studies with a sample size of 2080 were included in this study. The overall success rate of VBAC was 52% (95% confidence interval 42 to 65). Cervical dilatation ≥4 cm at admission, having a prior successful vaginal delivery and VBAC were the predictors of successful VBAC.ConclusionsMeta-analyses and sensitivity analyses showed the stability of the pooled odds ratios and the funnel plots did not show publication bias. The pooled prevalence of successful VBAC was relatively low compared with existing evidence. However, the rate was increasing over the last 3 decades, which implies it needs more strengthening and focus to decrease maternal morbidity and mortality by CS complications. Promoting VBAC by emphasizing factors favourable for its success during counselling mothers who previously delivered by CS to enhance the prevalence of VBAC.
| S-EPMC11218884 | biostudies-literature