Dataset Information

Feasibility of Conducting a Trial Assessing Benefits and Risks of Planned Caesarean Section Versus Planned Vaginal Birth: A Cross-Sectional Study.

ABSTRACT:

Introduction

Though 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.

Methods

A 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.

Results

Few 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 practice

Important 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.

SUBMITTER: Amyx MM

PROVIDER: S-EPMC7922524 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

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.

Project description:ObjectivesTo assess the feasibility of conducting a randomised placebo-controlled trial of corticosteroids prior to planned caesarean section from 35+0 to 39+6 weeks.DesignA triple-blind, placebo-controlled, parallel, trial randomised at the participant level (1:1 ratio). Additional feasibility data obtained by questionnaires from trial participants and women who declined trial participation, and focus groups with local site researchers and clinicians.SettingThree obstetric units in New Zealand including tertiary and secondary care; public and private care, and research active and non-active units.ParticipantsWomen undergoing a planned caesarean section from 35+0 to 39+6 weeks; local site researchers and clinicians.InterventionsTwo doses of 11.4 mg betamethasone or saline placebo. Questionnaires and focus group meetings.Primary and secondary outcome measuresPrimary outcome: trial recruitment rate of eligible women.Secondary outcomestrial recruitment by gestational age, site and delivery indication; proportion of babies who completed measurements of blood glucose concentrations as per protocol; overall incidence neonatal respiratory distress requiring >60 min of respiratory support; overall incidence of neonatal hypoglycaemia, and barriers and enablers to trial participation by participants, researchers and clinicians.ResultsThe recruitment rate was 8.9% (88/987) overall and 11.2% (88/789) for those approached about the trial. Neonatal blood glucose concentrations were measured as per protocol in 87/92 (94.6%) babies. For potential participants, key enablers to participation were contributing to research, a feeling of relevance and a good understanding; key barriers were a lack of understanding and concerns over safety. For researchers and clinicians, themes representing enablers and barriers included relevance, communication and awareness, influences on women's decision-making, resource challenges and trial process practicalities.ConclusionsSome women are willing to participate in a randomised placebo-controlled trial of corticosteroids prior to a planned caesarean section birth at late preterm and term gestations. Participation in such a trial can be enhanced.

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.

Project description: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.

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.

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.

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.