Novel device for assisted vaginal birth: using integrated qualitative case study methodology to optimise Odon Device use within a feasibility study in a maternity unit in the Southwest of England.

OBJECTIVE: When novel devices are used 'in human' for the first time, their optimal use is uncertain because clinicians only have experience from preclinical studies. This study aimed to investigate factors that might optimise use of the Odon Device for assisted vaginal birth. DESIGN: We undertook qualitative case studies within the ASSIST Study, a feasibility study of the Odon Device. Each 'case' was defined as one use of the device and included at least one of the following: observation of the attempted assisted birth, and an interview with the obstetrician, midwife or woman. Data collection and thematic analysis ran iteratively and in parallel. SETTING: Tertiary referral National Health Service maternity unit in the Southwest of England. PARTICIPANTS: Women requiring a clinically indicated assisted vaginal birth. INTERVENTION: The Odon Device, an innovative device for assisted vaginal birth. PRIMARY AND SECONDARY OUTCOME MEASURES: Determining the optimal device technique, device design and defining clinical parameters for use. RESULTS: Thirty-nine cases involving an attempted Odon-assisted birth were included in this study, of which 19 resulted in a successful birth with the device. Factors that improved use included optimisation of device technique, device design and clinical parameters for use. Technique adaptations included: applying the device during, rather than between, contractions; having a flexible approach to the application angle; and deflating the air cuff sooner than originally proposed. Three design modifications were proposed involving the deflation button and sleeve. Although use of the device was found to be appropriate in all fetal positions, it was considered contraindicated when the fetal station was at the ischial spines. CONCLUSIONS: Case study methodology facilitated the acquisition of rapid insights into device function in clinical practice, providing key insights regarding use, design and key clinical parameters for success. This methodology should be considered whenever innovative devices are introduced into clinical practice. TRIAL REGISTRATION NUMBER: ISRCTN10203171.

Women's experiences of the Odon Device to assist vaginal birth and participation in intrapartum research: a qualitative study in a maternity unit in the Southwest of England.

OBJECTIVE: To investigate women's experiences of having a birth assisted by the Odon Device (an innovative device for assisted vaginal birth) and participation in intrapartum research. DESIGN: Qualitative semistructured interviews and observations undertaken in the context of case study work embedded in the ASSIST feasibility study. SETTING: A tertiary referral National Health Service (NHS) maternity unit in the Southwest of England, between 8 October 2018 and 26 January 2019. PARTICIPANTS: Eight women, four operators and 11 midwives participated with eight observations of the assisted vaginal birth, eight interviews with women in the postnatal period, 39 interviews/reflections with operators and 19 interviews with midwives. Women in the case study research were recruited from participants in the main ASSIST Study. INTERVENTION: The Odon Device, an innovative device for assisted vaginal birth. RESULTS: Thirty-nine case studies were undertaken. Triangulation of data sources (participant observation, interviews with women, operators and midwives) enabled the exploration of women's experiences of the Odon Device and recruitment in the intrapartum trial. Experiences were overwhelmingly positive. Women were motivated to take part by a wish for a kinder birth, and because they perceived both the recruitment and research processes (including observation) to be highly acceptable, regardless of whether the Odon-assisted birth was successful or not. CONCLUSIONS: Interviews and observations from multiple stakeholders enabled insight into women's experiences of an innovative device for assisted vaginal birth. Applying these qualitative methods more broadly may illuminate perspectives of key stakeholders in future intrapartum intervention research and beyond. TRIAL REGISTRATION NUMBER: ISRCTN10203171; ASSIST Study registration; https://doi.org/10.1186/ISRCTN10203171.

Intrapartum and neonatal mortality in low-risk term women in midwife-led care and obstetrician-led care at the onset of labor: A national matched cohort study.

INTRODUCTION: Midwife-led models of care have been the subject of debate for many years. We conducted a study to compare intrapartum and neonatal mortality rates in midwife-led (primary) vs obstetrician-led (secondary) care at the onset of labor in low-risk term women. MATERIAL AND METHODS: We performed an unmatched and a propensity score matched cohort study using data from the national perinatal audit registry (PAN) and from the national perinatal registry (PERINED) of the Netherlands. We included women with singleton pregnancies (without congenital anomalies or antepartum fetal death) who gave birth at term between 2010 and 2012. We excluded the following major risk factors: non-vertex position of the fetus, previous cesarean birth, hypertension, diabetes mellitus, prolonged rupture of membranes (≥24 hours), vaginal bleeding in the second half of pregnancy, nonspontaneous start of labor and post-term pregnancy (≥42 weeks). The primary outcome was intrapartum or neonatal mortality up to 28 days after birth. Secondary outcome measures were mode of delivery and a 5-minute Apgar score <7. RESULTS: We included 259 211 women. There were 100/206 642 (0.48‰) intrapartum and neonatal deaths in the midwife group and 23/52 569 (0.44‰) in the obstetrician group (odds ratio [OR] 1.11, 95% CI 0.70-1.74). Propensity score matched analysis showed mortality rates of 0.49‰ (26/52 569) among women in midwife-led care and 0.44‰ (23/52 569) for women in obstetrician-led care (OR 1.13, 95% CI 0.65-1.98). In the midwife group there were significantly lower rates of vaginal instrumental deliveries (8.4% vs 13.0%; matched OR 0.65, 95% CI 0.62-0.67) and intrapartum cesarean sections (2.6% vs 8.2%; matched OR 0.32, 95% CI 0.30-0.34), and fewer neonates with low Apgar scores (<7 after 5 minutes) (0.69% vs 1.11%; matched OR 0.61, 95% CI 0.53-0.69). CONCLUSIONS: Among low-risk term women, there were comparable intrapartum and neonatal mortality rates for women starting labor in midwife-led vs obstetrician-led care, with lower intervention rates and fewer low Apgar scores in the midwife group.

Public provision of emergency obstetric care: a case study in two districts of Pakistan.

OBJECTIVES: Pakistan is one out of five countries where together half of the global neonatal deaths occur. As the provision of services and facilities is one of the key elements vital to reducing this rate as well as the maternal mortality rate, this study investigates the status of the delivery of essential obstetric care provided by the public health sector in two districts in Khyber Pakhtunkhwa in 2015 aiming to highlight areas where critical improvements are needed. SETTING: We analysed data from a survey of 22 primary and secondary healthcare facilities as well as 85 community midwives (CMWs) in Haripur and Nowshera districts. PARTICIPANTS: Using a structured questionnaire we evaluated the performance of emergency obstetric care (EmOC) signal functions and patient statistics in public health facilities. Also, 102 CMWs were interviewed about working hours, basic and specialised delivery service provision, referral system and patient statistics. PRIMARY OUTCOME MEASURES: We investigate the public provision of emergency obstetric care using seven key medical services identified by the United Nations (UN). RESULTS: Deliveries by public health cadres account for about 30% of the total number of births in these districts. According to the UN benchmark, only a small fraction of basic EmOC (2/18) and half of the comprehensive EmOC (2/4) facilities of the recommended minimum number were available to the population in both districts. Only a minority of health facilities and CMWs carry out several signal functions. Only 8% of the total births in one of the study districts are performed in public EmOC health facilities. CONCLUSIONS: Both districts show a significant shortage of available public EmOC service provisions. Development priorities need to be realigned to improve the availability, accessibility and quality of EmOC service provisions by the public health sector alongside with existing activities to increase institutional births.

Birth Outcomes for Midwifery Clients Who Begin Postdates Induction of Labour Under Midwifery Care Compared With Those Who Are Transferred to Obstetrical Care.

OBJECTIVE: This study sought to compare clinical outcomes of midwifery clients who had postdates induction of labour with oxytocin under midwifery care with those transferred to obstetrical care. METHODS: This was a retrospective cohort study using 2006-2009 Ontario Midwifery Program data. All low-risk Ontario midwifery clients who had postdates oxytocin induction were included. Groups were established according to the planned care provider at onset of induction. The primary outcome was Cesarean section (CS). The secondary outcome was a composite of stillbirth, neonatal death, or serious morbidity. Other outcomes included assisted vaginal delivery, pharmaceutical pain relief, and use of episiotomy. We stratified by parity and used logistic regression to conduct analyses controlling for maternal age (Canadian Task Force Classification II-2). RESULTS: For nulliparas, postdates induction with oxytocin under midwifery care decreased the odds of interventions including assisted vaginal delivery (OR 0.68; 95% CI 0.48-0.97), episiotomy (OR 0.49; 95% CI 0.34-0.70), and pharmaceutical pain relief (OR 0.57; 95% CI 0.36-0.90), with no difference in odds of neonatal morbidity or mortality (OR 0.71; 95% CI 0.25-2.04) when compared with induction under obstetrical care. For multiparas, the use of pharmaceutical pain relief was significantly lower in the midwifery group (OR 0.65; 95% CI 0.44-0.96). CONCLUSION: For low-risk midwifery clients at 41 weeks or more gestation, the odds of Caesarean section and neonatal morbidity and mortality are similar when induction of labour with oxytocin under the care of a midwife is compared with induction of labour under obstetrical care, and rates of intervention are decreased.

Getting the first birth right: A retrospective study of outcomes for low-risk primiparous women receiving standard care versus midwifery model of care in the same tertiary hospital.

BACKGROUND: There is national and international concern for increasing obstetric intervention in childbirth and rising caesarean section rates. Repeat caesarean section is a major contributing factor, making primiparous women an important target for strategies to reduce unnecessary intervention and surgeries in childbirth. AIM: The aim was to compare outcomes for a cohort of low risk primiparous women who accessed a midwifery continuity model of care with those who received standard public care in the same tertiary hospital. METHODS: A retrospective comparative cohort study design was implemented drawing on data from two databases held by a tertiary hospital for the period 1 January 2010 to 31 December 2011. Categorical data were analysed using the chi-squared statistic and Fisher's exact test. Continuous data were analysed using Student's t-test. Comparisons are presented using unadjusted and adjusted odds ratios, with 95% confidence intervals (CIs) and p-values with significance set at 0.05. RESULTS: Data for 426 women experiencing continuity of midwifery care and 1220 experiencing standard public care were compared. The study found increased rates of normal vaginal birth (57.7% vs. 48.9% p=0.002) and spontaneous vaginal birth (38% vs. 22.4% p=<0.001) and decreased rates of instrumental birth (23.5% vs. 28.5% p=0.050) and caesarean sections (18.8% vs. 22.5% p=0.115) in the midwifery continuity cohort. There were also fewer interventions in this group. No differences were found in neonatal outcomes. CONCLUSION: Strategies for reducing caesarean section rates and interventions in childbirth should focus on primiparous women as a priority. This study demonstrates the effectiveness of continuity midwifery models, suggesting that this is an important strategy for improving outcomes in this population.

Impact of maternity care policy in Catalonia: a retrospective cross-sectional study of service delivery in public and private hospitals.

BACKGROUND: As a result of the growing number of interventions that are now performed in the context of maternity care, health authorities have begun to examine the possible repercussions for service provision and for maternal and neonatal health. In Spain the Strategy Paper on Normal Childbirth was published in 2008, and since then the authorities in Catalonia have sought to implement its recommendations. This paper reviews the current provision of maternity care in Catalonia. METHODS: This was a descriptive study. Hospitals were grouped according to their source of funding (public or private) and were stratified (across four strata) on the basis of the annual number of births recorded within their respective maternity service. Data regarding the distribution of obstetric professionals were taken from an official government survey of hospitals published in 2010. The data on obstetric interventions (caesarean, use of forceps, vacuum or non-specified instruments) performed in 2007, 2010 and 2012 were obtained by consulting discharge records of 44 public and 20 private hospitals, which together provide care in 98% of all births in Catalonia. Proportions and confidence intervals were calculated for each intervention performed in all full-term (37-42 weeks) singleton births. RESULTS: Analysis of staff profiles according to the stratification of hospitals showed that almost all the hospitals had more obstetricians than midwives among their maternity care staff. Public hospitals performed fewer caesareans [range between 19.20% (CI 18.84-19.55) and 28.14% (CI 27.73-28.54)] than did private hospitals [range between 32.21% (CI 31.78-32.63) and 39.43% (CI 38.98-39.87)]. The use of forceps has decreased in public hospitals. The use of a vacuum extractor has increased and is more common in private hospitals. CONCLUSIONS: Caesarean section is the most common obstetric intervention performed during full-term singleton births in Catalonia. The observed trend is stable in the group of public hospitals, but shows signs of a rise among private institutions. The number of caesareans performed in accredited public hospitals covers a limited range with a stable trend. Among public hospitals the highest rate of caesareans is found in non-accredited hospitals with a lower annual number of births.

Caseload midwifery compared to standard or private obstetric care for first time mothers in a public teaching hospital in Australia: a cross sectional study of cost and birth outcomes.

BACKGROUND: In many countries midwives act as the main providers of care for women throughout pregnancy, labour and birth. In our large public teaching hospital in Australia we restructured the way midwifery care is offered and introduced caseload midwifery for one third of women booked at the hospital. We then compared the costs and birth outcomes associated with caseload midwifery compared to the two existing models of care, standard hospital care and private obstetric care. METHODS: We undertook a cross sectional study examining the risk profile, birth outcomes and cost of care for women booked into one of the three available models of care in a tertiary teaching hospital in Australia between July 1st 2009 December 31st 2010. To control for differences in population or case mix we described the outcomes for a cohort of low risk first time mothers known as the 'standard primipara'. RESULTS: Amongst the 1,379 women defined as 'standard primipara' there were significant differences in birth outcome. These first time 'low risk' mothers who received caseload care were more likely to have a spontaneous onset of labour and an unassisted vaginal birth 58.5% in MGP compared to 48.2% for Standard hospital care and 30.8% with Private obstetric care (p < 0.001). They were also significantly less likely to have an elective caesarean section 1.6% with MGP versus 5.3% with Standard care and 17.2% with private obstetric care (p < 0.001). From the public hospital perspective, over one financial year the average cost of care for the standard primipara in MGP was $3903.78 per woman. This was $1375.45 less per woman than those receiving Private obstetric care and $1590.91 less than Standard hospital care per woman (p < 0.001). Similar differences in cost were found in favour of MGP for all women in the study who received caseload care. CONCLUSIONS: Cost reduction appears to be achieved through reorganising the way care is delivered in the public hospital system with the introduction of Midwifery Group Practice or caseload care. The study also highlights the unexplained clinical variation that exists between the three models of care in Australia.

Optimization of competency in obstetrical emergencies: a role for simulation training.

PURPOSE: In obstetrical emergency situations, optimal management requires the immediate coordinated actions of a multi-disciplinary and multi-professional team. This study investigated the influence of simulation training on four specific skills: self-confidence, handling of emergency situation, knowledge of algorithms and team communication. METHODS: Clinical algorithms were first presented to the participants. Training for six emergency situations (shoulder dystocia, postpartum haemorrhage, pre-eclampsia, maternal basic life support, neonatal resuscitation and operative vaginal birth) was performed using high- and low-fidelity simulation mannequins. General impression of the simulation training and the four above-mentioned skills were evaluated anonymously through a self-assessment questionnaire with a five-point Likert scale immediately after the training and 3 months later. RESULTS: From November 2010 to March 2012, 168 participants, distributed over six one-day courses, took part in the training. 156 participants returned the questionnaire directly after the course (92.9 %). The questionnaire return rate after 3 months was 36.3 %. The participants gave higher Likert scale answers for the questions on the four specific skills after 3 months compared to immediately after the course. The improvement was statistically significant (p ≤ 0.05) except for the question regarding team communication. CONCLUSION: Implementation of simulation training strengthens the professional competency.

Instrumental vaginal deliveries; are midwives safer practitioners? A retrospective cohort study.

OBJECTIVE: To compare obstetric morbidity of midwife-performed instrumental vaginal deliveries with those performed by doctors. DESIGN: Retrospective cohort study. SETTING: University Hospital, UK. POPULATION: Women undergoing an instrumental vaginal delivery of a singleton infant outside of the operating theater in Aberdeen Maternity Hospital, between June 2005 and June 2010. METHODS: Prospectively entered data were obtained from the hospital data management system. Obstetric outcomes of deliveries by midwives were compared with those performed by any doctor and, in a secondary analysis, with those by junior doctors (fewer than two years at 'registrar' level). Sociodemographic characteristics and clinical outcomes were compared using the chi-squared test, Mann-Whitney U-test and independent sample t-test. MAIN OUTCOME MEASURES: Third- or fourth-degree tears. RESULTS: Among 2540 women identified, 330 (13%) were delivered by midwives. Maternal and clinical characteristics were comparable in each group. Midwives were more likely to use ventouse as their instrument of choice. Women delivered by midwives were less likely to suffer a third- or fourth-degree tears than those delivered by doctors and junior doctors. This difference did not reach statistical significance once adjusted for instrument used: odds ratio 0.6 (95% confidence interval: 0.3-1.2) and odds ratio 0.6 (95% confidence interval: 0.3-1.1), respectively. CONCLUSIONS: Instrumental vaginal deliveries performed by trained midwives are associated with equivalent maternal morbidity to those performed by doctors once adjusted for midwives' preference for the ventouse. This study highlights the potential contribution of an advanced role for midwives in the labor ward.

Amniotomy and cord prolapse.

Research shows that artificially rupturing the amniotic sac (amniotomy) can cause umbilical cord prolapse. Amniotomy became a routine part of obstetrical care with the introduction of active management, without evidence of benefit. In the 30 years since active management was introduced, the rate at which amniotomy causes umbilical cord prolapse has not been directly studied. Two controlled studies from Turkey from 2002 and 2006 are the only published studies that provide enough data to extract the rate at which cord prolapse follows amniotomy. They show that 1 cord prolapse results from every 300 amniotomies (0.3%). There is data suggesting amniotomy may also increase neonatal GBS infection, maternal pain and fetal blood loss if placental blood vessels are punctured.

Effects of continuity of care by a primary midwife (caseload midwifery) on caesarean section rates in women of low obstetric risk: the COSMOS randomised controlled trial.

OBJECTIVE: To determine whether primary midwife care (caseload midwifery) decreases the caesarean section rate compared with standard maternity care. DESIGN: Randomised controlled trial. SETTING: Tertiary-care women's hospital in Melbourne, Australia. POPULATION: A total of 2314 low-risk pregnant women. METHODS: Women randomised to caseload received antenatal, intrapartum and postpartum care from a primary midwife with some care by 'back-up' midwives. Women randomised to standard care received either midwifery or obstetric-trainee care with varying levels of continuity, or community-based general practitioner care. PRIMARY OUTCOME: caesarean birth. Secondary outcomes included instrumental vaginal births, analgesia, perineal trauma, induction of labour, infant admission to special/neonatal intensive care, gestational age, Apgar scores and birthweight. RESULTS: In total 2314 women were randomised-1156 to caseload and 1158 to standard care. Women allocated to caseload were less likely to have a caesarean section (19.4% versus 24.9%; risk ratio [RR] 0.78; 95% CI 0.67-0.91; P = 0.001); more likely to have a spontaneous vaginal birth (63.0% versus 55.7%; RR 1.13; 95% CI 1.06-1.21; P < 0.001); less likely to have epidural analgesia (30.5% versus 34.6%; RR 0.88; 95% CI 0.79-0.996; P = 0.04) and less likely to have an episiotomy (23.1% versus 29.4%; RR 0.79; 95% CI 0.67-0.92; P = 0.003). Infants of women allocated to caseload were less likely to be admitted to special or neonatal intensive care (4.0% versus 6.4%; RR 0.63; 95% CI 0.44-0.90; P = 0.01). No infant outcomes favoured standard care. CONCLUSION: In settings with a relatively high baseline caesarean section rate, caseload midwifery for women at low obstetric risk in early pregnancy shows promise for reducing caesarean births.

Midwives, labour induction and the Wooden Spoon award Part 2.

Rates of labour induction without clear medical indication have risen exponentially. This trend has not been without consequence of increased perinatal mortality and morbidity. Midwives must understand the importance of educating pregnant women and other obstetrical providers, about the risks associated with labour induction. Maternal-child health policy that minimises unnecessary interventions is urgently needed and prevention strategies are described in the second part of this article. Midwives are challenged to consider their role in reducing unnecessary labour inductions in a rapidly changing birth culture reflecting high intervention.

Midwives, labour induction and the Wooden Spoon award part I.

Labour induction rates have rocketed, largely due to consumer demands and provider convenience. This increase has been a significant factor in rapidly increasing caesarean birth rates and adverse perinatal outcomes. It is important that midwives understand the risks associated with labour induction. The article overviews those factors contributing to increasing induction rates and the associated risks. Midwives are challenged to consider the evidence for an intervention contributing to a cascade of birth interventions.

Non-technical skills for obstetricians conducting forceps and vacuum deliveries: qualitative analysis by interviews and video recordings.

OBJECTIVE: Non-technical skills are cognitive and social skills required in an operational task. These skills have been identified and taught in the surgical domain but are of particular relevance to obstetrics where the patient is awake, the partner is present and the clinical circumstances are acute and often stressful. The aim of this study was to define the non-technical skills of an operative vaginal delivery (forceps or vacuum) to facilitate transfer of skills from expert obstetricians to trainee obstetricians. STUDY DESIGN: Qualitative study using interviews and video recordings. The study was conducted at two university teaching hospitals (St. Michael's Hospital, Bristol and Ninewells Hospital, Dundee). Participants included 10 obstetricians and eight midwives identified as experts in conducting or supporting operative vaginal deliveries. Semi-structured interviews were carried out using routine clinical scenarios. The experts were also video recorded conducting forceps and vacuum deliveries in a simulation setting. The interviews and video recordings were transcribed verbatim and analysed using thematic coding. The anonymised data were independently coded by the three researchers and then compared for consistency of interpretation. The experts reviewed the coded data for respondent validation and clarification. The themes that emerged were used to identify the non-technical skills required for conducting an operative vaginal delivery. RESULTS: The final skills list was classified into seven main categories. Four categories (situational awareness, decision making, task management, and team work and communication) were similar to the categories identified in surgery. Three further categories unique to obstetrics were also identified (professional relationship with the woman, maintaining professional behaviour and cross-monitoring of performance). CONCLUSION: This explicitly defined skills taxonomy could aid trainees' understanding of the non-technical skills to be considered when conducting an operative vaginal delivery and potentially reduce morbidity and improve the experience of delivery for the mother.