Assisted vaginal birth in 21st century: current practice and new innovations.

Assisted vaginal birth rates are falling globally with rising cesarean delivery rates. Cesarean delivery is not without consequence, particularly when carried out in the second stage of labor. Cesarean delivery in the second stage is not entirely protective against pelvic floor morbidity and can lead to serious complications in a subsequent pregnancy. It should be acknowledged that the likelihood of morbidity for mother and baby associated with cesarean delivery increases with advancing labor and is greater than spontaneous vaginal birth, irrespective of the method of operative birth in the second stage of labor. In this article, we argue that assisted vaginal birth is a skilled and safe option that should always be considered and be available as an option for women who need assistance in the second stage of labor. Selecting the most appropriate mode of birth at full dilatation requires accurate clinical assessment, supported decision-making, and personalized care with consideration for the woman's preferences. Achieving vaginal birth with the primary instrument is more likely with forceps than with vacuum extraction (risk ratio, 0.58; 95% confidence interval, 0.39-0.88). Midcavity forceps are associated with a greater incidence of obstetric anal sphincter injury (odds ratio, 1.83; 95% confidence interval, 1.32-2.55) but no difference in neonatal Apgar score or umbilical artery pH. The risk for adverse outcomes is minimized when the procedure is conducted by a skilled accoucheur who selects the most appropriate instrument likely to achieve vaginal birth with the primary instrument. Anticipation of potential complications and dynamic decision-making are just as important as the technique for safe instrument use. Good communication with the woman and the birthing partner is vital and there are various recommendations on how to achieve this. There have been recent developments (such as OdonAssist) in device innovation, training, and strategies for implementation at a scale that can provide opportunities for both improved outcomes and reinvigoration of an essential skill that can save mothers' and babies' lives across the world.

The OdonAssist inflatable device for assisted vaginal birth-the ASSIST II study (United Kingdom).

BACKGROUND: Decreasing rates of assisted vaginal birth have been paralleled with increasing rates of cesarean deliveries over the last 40 years. The OdonAssist is a novel device for assisted vaginal birth. Iterative changes to clinical parameters, device design, and technique have been made to improve device efficacy and usability. OBJECTIVE: This study aimed to determine if the feasibility, safety, and efficacy of the OdonAssist device were sufficient to justify conducting a future randomized controlled trial. STUDY DESIGN: An open-label nonrandomized study of 104 participants having a clinically indicated assisted vaginal birth using the OdonAssist was undertaken at Southmead Hospital, Bristol, United Kingdom. Data were also collected from participants who consented to participate in the study but for whom trained OdonAssist operators were not available, providing a nested cohort. The primary clinical outcome was the proportion of births successfully expedited with the OdonAssist. Secondary outcomes included clinical, patient-reported, operator-reported, device and health care utilization. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90. Given that the number of successful OdonAssist births was ≥61 out of 104, the hypothesis of a poor rate of 50% was rejected in favor of a good rate of ≥65%. RESULTS: Between August 2019 and June 2021, 941 (64%) of the 1471 approached, eligible participants consented to participate. Of these, 104 received the OdonAssist intervention. Birth was assisted in all cephalic vertex fetal positions, at all stations ≥1 cm below the ischial spines (with or without regional analgesia). The OdonAssist was effective in 69 of the 104 (66%) cases, consistent with the hypothesis of a good efficacy rate. There were no serious device-related maternal or neonatal adverse reactions, and there were no serious adverse device effects. Only 4% of neonatal soft tissue bruising in the successful OdonAssist group was considered device-related, as opposed to 20% and 23% in the unsuccessful OdonAssist group and the nested cohort, respectively. Participants reported high birth perception scores. All practitioners found the device use to be straightforward. CONCLUSION: Recruitment to an interventional study of a new device for assisted vaginal birth is feasible; 64% of eligible participants were willing to participate. The success rate of the OdonAssist was comparable to that of the Kiwi OmniCup when introduced in the same unit in 2002, meeting the threshold for a randomized controlled trial to compare the OdonAssist with current standard practice. There were no disadvantages of study participation in terms of maternal and neonatal outcomes. There were potential advantages of using the OdonAssist, particularly reduced neonatal soft tissue injury. The same application technique is used for all fetal positions, with all operators deeming the device straightforward to use. This study provides important data to inform future study design.

The use of bubble charts in analyzing second stage cesarean delivery rates.

BACKGROUND: The incidence of second stage cesarean delivery has been rising globally because of the failure or the anticipated difficulty of performing instrumental delivery. Yet, the best way to interpret the figure and its optimal rate remain to be determined. This is because it is strongly influenced by the practice of other 2 modes of birth, namely cesarean delivery performed before reaching the second stage and assisted vaginal birth during the second stage. In this regard, a bubble chart that can display 3-dimensional data through its x-axis, y-axis, and the size of each plot (presented as a bubble) may be a suitable method to evaluate the relationship between the rates of these 3 modes of births. OBJECTIVE: This study aimed to conduct an epidemiologic study on the incidence of second stage cesarean deliveries rates among >300,000 singleton term births in 10 years from 8 obstetrical units and to compare their second stage cesarean delivery rates in relation to their pre-second stage cesarean delivery rates and assisted vaginal birth rates using a bubble chart. STUDY DESIGN: The territory-wide birth data collected between 2009 and 2018 from all 8 public obstetrical units (labelled as A to H) were reviewed. The inclusion criteria were all singleton pregnancies with cephalic presentation that were delivered at term (≥37 weeks' gestation). Pre-second stage cesarean delivery rate was defined as all elective cesarean deliveries and those emergency cesarean deliveries that occurred before full cervical dilatation was achieved as a proportion of the total number of births. The second stage cesarean delivery rate and assisted vaginal birth rate were calculated according to the respective mode of delivery as a proportion of the number of cases that reached full cervical dilatation. The rates of these 3 modes of births were compared among the parity groups and among the 8 units. Using a bubble chart, each unit's second stage cesarean delivery rate (y-axis) was plotted against its pre-second stage cesarean delivery rate (x-axis) as a bubble. Each unit's second stage cesarean delivery to assisted vaginal birth ratio was represented by the size of the bubble. RESULTS: During the study period, a total of 353,434 singleton cephalic presenting term pregnancies were delivered in the 8 units, and 180,496 (51.1%) were from nulliparous mothers. When compared with the multiparous group, the nulliparous group had a significantly lower pre-second stage cesarean delivery rate (18.58% vs 21.26%; P<.001) but a higher second stage cesarean delivery rate (0.79% vs 0.22%; P<.001) and a higher assisted vaginal birth rate (17.61% vs 3.58%; P<.001). Using the bubble of their averages as a reference point in the bubble chart, the 8 units' bubbles were clustered into 5 regions indicating their differences in practice: unit B and unit H were close to the average in the center. Unit A and unit F were at the upper right corner with a higher pre-second stage cesarean delivery rate and second stage cesarean delivery rate. Unit D and unit E were at the opposite end. Unit C was at the upper left corner with a low pre-second stage cesarean delivery rate but a high second stage cesarean delivery rate, whereas unit G was at the opposite end. Unit C and unit G were also in the extremes in terms of pre-second stage cesarean delivery to assisted vaginal birth ratio (0.09 and 0.01, respectively). Although some units seemed to have very similar second stage cesarean delivery rates, their obstetrical practices were differentiated by the bubble chart. CONCLUSION: The second stage cesarean delivery rate must be evaluated in the context of the rates of pre-second stage cesarean delivery and assisted vaginal birth. A bubble chart is a useful method for analyzing the relationship among these 3 variables to differentiate the obstetrical practice between different units.

Mode of birth in subsequent pregnancy when first birth was vacuum extraction or second stage cesarean section at a tertiary referral hospital in Uganda.

INTRODUCTION: The trends of increasing use of cesarean section (CS) with a decrease in assisted vaginal birth (vacuum extraction or forceps) is a major concern in health care systems all over the world, particularly in low-resource settings. Studies show that a first birth by CS is associated with an increased risk of repeat CS in subsequent births. In addition, CS compared to assisted vaginal birth (AVB), attracts higher health service costs. Resource-constrained countries have low rates of AVB compared to high-income countries. The aim of this study was to compare mode of birth in the subsequent pregnancy among women who previously gave birth by vacuum extraction or second stage CS in their first pregnancy at Mulago National Referral Hospital, Uganda. METHODS: This was a retrospective cohort study that involved interviews of 81 mothers who had a vacuum extraction or second stage CS in their first pregnancy at Mulago hospital between November 2014 to July 2015. Mode of birth in the subsequent pregnancy was compared using Chi-2 square test and a Fisher's exact test with a 0.05 level of statistical significance. RESULTS: Higher rates of vaginal birth were achieved among women who had a vacuum extraction (78.4%) compared to those who had a second stage CS in their first pregnancy (38.6%), p < 0.001. CONCLUSIONS AND RECOMMENDATIONS: Vacuum extraction increases a woman's chance of having a subsequent spontaneous vaginal birth compared to second stage CS. Health professionals need to continue to offer choice of vacuum extraction in the second stage of labor among laboring women that fulfill its indication. This will help curb the up-surging rates of CS.

Engaging women to set the research agenda for assisted vaginal birth.

INTRODUCTION: Public and patient involvement can provide crucial insights to optimise research by enhancing relevance and appropriateness of studies. The World Health Organization (WHO) engaged in an inclusive process to ensure that both technical experts and women had a voice in defining the research gaps and needs to increase or reintroduce the use of assisted vaginal birth (AVB) in settings where this intervention is needed but unavailable or underused. METHODS: We describe the methods and outcomes of online workshops led by WHO to obtain women representatives' perspectives about AVB research gaps and needs. RESULTS: After technical experts created a list of research questions based on various evidence syntheses, WHO organised four online workshops with 31 women's representatives from 27 mostly low- and middle-income (LMIC) countries. Women rated the importance and priority of the research questions proposed by the technical experts, improving and broadening some of them, added new questions, and voiced their main concerns and views about AVB. Women helped to put the research questions into context in their communities, highlighted neglected factors/dimensions that influence practices and affect women's experience during labour and childbirth, underscored less salient consequences of AVB, and highlighted the main concerns of women about research on AVB. The consolidated vision of technical experts and women's representatives resulted in a technical brief published by WHO. The technical brief is expected to stimulate global research and action closely aligned with women's priorities. CONCLUSIONS: We describe a successful experience of engaging women, mostly from LMICs, in the identification of research gaps and needs to reintroduce AVB use. This process contributed to better aligning research questions with women's views, concerns, and priorities. Given the scarcity of reports about engaging women from LMICs to optimise research, this successful experience can serve as an inspiration for future work. PATIENT OR PUBLIC CONTRIBUTION: Women representatives were involved at every stage of the workshops described in full in this manuscript.

"To get the baby out off the hook": a prospective, longitudinal, multicenter, observational study about decision making in vacuum-assisted operative vaginal delivery.

BACKGROUND: Since operative vaginal delivery may be risky for women and might cause neonatal complications, the aim of this study is to assess appropriateness of the procedure. This is a prospective, longitudinal, multicenter, observational study and it was conducted in three Italian Obstetric Units (Pisa, Massa Carrara and Prato). All term pregnant women, either nulliparous and multiparous, with singleton pregnancy and a cephalic fetus, with spontaneous or induced labour, requiring vacuum-assisted delivery were enrolled. Indications to operative vaginal delivery were grouped as alterations of fetal cardiotocography (CTG) patterns, delay/arrest of second stage of labour or elective shortening of second stage of labour. A board consisting of five among authors evaluated appropriateness of the procedure. RESULTS: Overall, 466 women undergoing operative vaginal deliveries were included. Cardiotocography, classified as ACOG category 2 or 3 was the indication for vacuum assisted delivery in 253 patients (54.29%). Among these, 66 women (26.1%) had an operative vaginal delivery which was then considered to be inappropriate, while in 114 cases (45.1%) CTG traces resulted to be unreadable. CONCLUSION: Decision making process, which leads clinicians to go for operative vaginal delivery, is often influenced by shortness of time and complexity of the situation. Therefore, clinicians tend to intervene performing vacuum delivery without adopting critical analysis and without adequately considering the clinical situation. Operative vaginal delivery might be a risky procedure and should be performed only when clinically indicated and after adequate critical analysis.

Outcomes of the novel Odon Device in indicated operative vaginal birth.

BACKGROUND: No new method of assisting vaginal birth has been introduced into clinical practice since the development of the vacuum extractor in the 1950s. The Odon Device is a new device that employs a circumferential air cuff over the fetal head to assist birth. In this study, the Odon Device has been used to assist vaginal birth for standard clinical indications. OBJECTIVE: This study aimed to investigate the clinical impact, safety, and acceptability of the Odon Device to women, their babies, and clinicians and to assess the feasibility of recruiting women to an interventional intrapartum research study. STUDY DESIGN: This is a nonrandomized, single-arm interventional feasibility study of the Odon Device for operative vaginal birth undertaken in a single maternity unit: Southmead Hospital, Bristol, United Kingdom. The Odon Device was used to assist birth in 40 women who required the birth to be assisted for suspected fetal compromise and/or prolonged second stage of labor. The primary clinical outcome was the proportion of births successfully assisted with the Odon Device, and the primary feasibility outcome was the proportion of eligible women who were approached and who agreed to participate. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90. RESULTS: Between October 2018 and January 2019, 298 of 384 approached, eligible women (77.6%) consented to participate. Of these women, 40 received the intervention-the use of the Odon Device. Birth was assisted in all cephalic (occiput anterior, occiput transverse, and occiput posterior) fetal positions, at all stations at or below the ischial spine and with or without regional analgesia. The Odon Device was effective in 19 of 40 cases (48%). Of the 40 births, 21 (52.5%) required additional assistance: 18 of 40 births (45%) were completed using nonrotational forceps, 1 of 40 births (3%) required rotational forceps, and 2 of 40 births (5%) required an emergency cesarean delivery. There was no serious maternal or neonatal adverse event related to the use of the device, and there was no serious adverse device effect. There were 4 devices (10%) that were ineffective because of a manufacturing fault. Furthermore, 39 of 40 women (98%) reported a high birth perception score. All practitioners were able to use the device as intended, although some steps in using the device were reported to be easier to perform (setup and deflation of air chamber) than others (application of the device and withdrawal of the applicator). CONCLUSION: Recruitment to an interventional study of a new device for operative vaginal birth was feasible; 78% of eligible women were willing to participate, often expressing an aspiration for an alternative to forceps and vacuum. The success rate of the Odon Device was lower than reported success rates of vacuum and forceps; however, in this study, the device had been used to assist birth for standard clinical indications. There was no significant maternal or neonatal safety concern associated with the use of the device, although the number of births studied was small. Further feasibility study to establish iterative changes to the device, technique, and clinical indications is necessary.

Training and expertise in undertaking assisted vaginal delivery (AVD): a mixed methods systematic review of practitioners views and experiences.

BACKGROUND: During childbirth, complications may arise which necessitate an expedited delivery of the fetus. One option is instrumental assistance (forceps or a vacuum-cup), which, if used with skill and sensitivity, can improve maternal/neonatal outcomes. This review aimed to understand the core competencies and expertise required for skilled use in AVD in conjunction with reviewing potential barriers and facilitators to gaining competency and expertise, from the point of view of maternity care practitioners, funders and policy makers. METHODS: A mixed methods systematic review was undertaken in five databases. Inclusion criteria were primary studies reporting views, opinions, perspectives and experiences of the target group in relation to the expertise, training, behaviours and competencies required for optimal AVD, barriers and facilitators to achieving practitioner competencies, and to the implementation of appropriate training. Quality appraisal was carried out on included studies. A mixed-methods convergent synthesis was carried out, and the findings were subjected to GRADE-CERQual assessment of confidence. RESULTS: 31 papers, reporting on 27 studies and published 1985-2020 were included. Studies included qualitative designs (3), mixed methods (3), and quantitative surveys (21). The majority (23) were from high-income countries, two from upper-middle income countries, one from a lower-income country: one survey included 111 low-middle countries. Confidence in the 10 statements of findings was mostly low, with one exception (moderate confidence). The review found that AVD competency comprises of inter-related skill sets including non-technical skills (e.g. behaviours), general clinical skills; and specific technical skills associated with particular instrument use. We found that practitioners needed and welcomed additional specific training, where a combination of teaching methods were used, to gain skills and confidence in this field. Clinical mentorship, and observing others confidently using the full range of instruments, was also required, and valued, to develop competency and expertise in AVD. However, concerns regarding poor outcomes and litigation were also raised. CONCLUSION: Access to specific AVD training, using a combination of teaching methods. Complements, but does not replace, close clinical mentorship from experts who are positive about AVD, and opportunities to practice emerging AVD skills with supportive supervision. Further research is required to ascertain effective modalities for wider training, education, and supportive supervision for optimal AVD use.

During the late stages of childbirth, complications can occur which require rapid birth of the baby. This can be facilitated with instruments (usually forceps or a suction cup) or by surgery (caesarean section). In some circumstances, instrumental birth (also termed assisted vaginal delivery, AVD) may be a better option than caesarean section. AVD requires practitioners to develop skills, competence and expertise in the procedure. Our aim for this review was to examine practitioners', funders' and policy makers' views about competence and expertise in AVD, how they can best gain this, the barriers and facilitators to implementing training packages, and their views, opinions and perspectives of their training. We included 27 studies (published 1985­2020), mostly from high-income countries. We had moderate confidence on one findings statement, with the rest assessed with low confidence. We found that practitioners valued extra training in AVD, observing others using the different instruments, and opportunities for clinical supervision, mentorship to gain experience, competence and expertise. We also found that, from the practitioners' perspective, competence encompasses a number of inter-related skill sets; non-technical skills (e.g. effective communication with the labouring woman), broad clinical skills (e.g. capacity to assess the whole clinical picture) and technical instrumental skills (e.g. correct application of a vacuum cup to the fetal head, or capacity to turn the baby so it is in the right position). Practitioners also identified a number of barriers and facilitators that supported (or did not support) their training needs and development.

Birth tears after spontaneous and vacuum-assisted births with different vacuum cup systems - a retrospective cohort study.

Objectives Birth tears are a common complication of vaginal childbirth. We aimed to evaluate the outcomes of birth tears first by comparing the mode of vaginal birth (VB) and then comparing different vacuum cups in instrumental VBs in order to better advise childbearing women and obstetrical professionals. Methods In a retrospective cohort study, we analyzed nulliparous and multiparous women with a singleton pregnancy in vertex presentation at ≥37 + 0 gestational weeks who gave birth vaginally at our tertiary care center between 06/2012 and 12/2016. We compared the distribution of tear types in spontaneous births (SBs) vs. vacuum-assisted VBs. We then compared the tear distribution in the vacuum group when using the Kiwi Omnicup or Bird's anterior metal cup. Outcome parameters were the incidence and distribution of the different tear types dependent on the mode of delivery and type of vacuum cup. Results A total of 4549 SBs and 907 VBs were analyzed. Birth tear distribution differed significantly between the birth modes. In 15.2% of women with an SB an episiotomy was performed vs. 58.5% in women with a VB. Any kind of perineal tear was seen in 45.7% after SB and in 32.7% after VB. High-grade obstetric anal sphincter injuries (OASIS) appeared in 1.1% after SB and in 3.1% after VB. No significant changes in tear distribution were found between the two different VB modes. Conclusions There were more episiotomies, vaginal tears and OASIS after VB than after SB. In contrast, there were more low-grade perineal and labial tears after SB. No significant differences were found between different vacuum cup systems, just a slight trend toward different tear patterns.

Operative vaginal delivery: a review of four national guidelines.

There is a broad range in the rates of operative vaginal deliveries (OVD) worldwide, which reflects the variety of local practice patterns, the number of trained clinicians and the lack of international evidence-based guidelines. The aim of this study was to review and compare the recommendations from published guidelines on OVD. Thus, a descriptive review of guidelines from the Royal College of Obstetricians and Gynaecologists (RCOG), the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the American College of Obstetricians and Gynecologists (ACOG) on instrumental vaginal birth was conducted. All the guidelines point out that the use of any instrument should be based on the clinical circumstances and the experience of the operator. The indications, the contraindications, the prerequisites and the classification for OVD are overall very similar in the reviewed guidelines. Further, they all agree that episiotomy should not be performed routinely. The RCOG, the RANZCOG and the SOGC describe some interventions which may promote spontaneous vaginal birth and therefore reduce the need for OVD. They also highlight the importance of adequate postnatal care and counseling. There is no consensus on the actual technique that should be used, including the type of forceps or vacuum cup, the force and duration of traction or the number of detachments allowed. Hence, there is need for international practice protocols, so as to encourage the clinicians to use OVD when indicated, minimize the complications and reduce rates of cesarean delivery.

No. 381-Assisted Vaginal Birth.

OBJECTIVES: To provide evidence-based guidelines for safe and effective assisted vaginal birth. OUTCOMES: Prerequisites, indications, contraindications, along with maternal and neonatal morbidity associated with assisted vaginal birth. EVIDENCE: Medline database was searched for articles published from January 1, 1985, to February 28, 2018 using the key words "assisted vaginal birth," "instrumental vaginal birth," "operative vaginal delivery," "forceps delivery," "vacuum delivery," "ventouse delivery." The quality of evidence is described using the Evaluation of Evidence criteria outlined in the Report of the Canadian Task Force on Preventive Health Care. VALIDATION: These guidelines were approved by the Clinical Practice Obstetrics Committee and the Board of the Society of Obstetricians and Gynaecologists of Canada.

Assessment of cerebral perfusion with contrast-enhanced ultrasound during constriction of the neck mimicking malposition of the BD Odon Device™: a study in newborn piglets.

OBJECTIVE: The BD Odon Device™ is a new instrument for operative vaginal birth with potential for preventing maternal, fetal and newborn morbidity/mortality during a complicated second stage of labour. The device is a plastic sleeve with an air chamber inflated around the baby's head which is gently pulled through the birth canal. The aim was to monitor changes in cerebral circulation during constriction of the neck to evaluate a risk of potential malposition of the device. DESIGN: Randomised prospective study. POPULATION OR SAMPLE: Twelve newborn piglets. METHODS: The anaesthetised piglets were exposed to hypoxia until base excess was -20 mmol/l and/or mean arterial blood pressure had decreased to 20 mmHg. At reoxygenation, an air chamber was inflated around the neck to 300 mmHg and the piglets randomised into three groups: 10 (n = 5), 5 (n = 5) or 2 (n = 2) minutes' occlusion. Cerebral perfusion was evaluated with transcranial contrast-enhanced ultrasound at four time-points, and analysed in the carotid arteries, basal ganglia, cortex and whole brain. Statistical analysis used ANOVA, linear mixed model, Kruskal-Wallis H-test. MAIN OUTCOME MEASURES: Perfusion parameters; peak intensity, time to peak intensity, upslope, mean transit time, area under the curve. RESULTS: The haemodynamic response was comparable between groups. Perfusion parameters showed a slight increase at end hypoxia followed by a decrease during occlusion, especially in the cortex (P = 0.00-0.2). After deflation, perfusion returned towards baseline values. CONCLUSIONS: Simulation of malposition of the Odon Device was performed using a newborn hypoxic piglet model. Considerable compression of the neck vessels was applied, with only a moderate decrease in perfusion and with restoration of haemodynamics/cerebral perfusion after decompression. TWEETABLE ABSTRACT: Malposition of Odon Device™ in a piglet model revealed a reversible decrease in cerebral perfusion during neck constriction.

Association of the Kiwi OmniCup system with maternal and neonatal morbidity: A retrospective cohort study.

OBJECTIVE: To discuss the effect of the Kiwi OmniCup system on reducing adverse maternal and neonatal outcomes and provide a reference for assisted vaginal delivery methods. METHODS: Women who gave birth to singleton term neonates in a cephalic presentation and underwent assisted vaginal delivery from 2017 to 2021 were eligible for inclusion in the study; they were divided into a Kiwi OmniCup system group and a forceps group. Binary logistic regression analysis was used to observe and compare maternal and neonatal outcomes. The primary outcomes were severe maternal and neonatal morbidity. Severe maternal morbidity was defined as the occurrence of at least one of the following outcomes: third- or fourth-degree perineal lacerations, refractory postpartum hemorrhage, thrombotic events, amniotic fluid embolism, admission to the intensive care unit, and maternal death. Severe neonatal morbidity was defined as the occurrence of at least one of the following outcomes: neonatal asphyxia requiring resuscitation or intubation, neonatal head and face injuries, neonatal fracture, and admission to the neonatal intensive care unit for longer than 24 h. RESULTS: The rate of severe neonatal morbidity in the forceps group was significantly higher than that in the Kiwi OmniCup system group, the differences between the two groups were significant (27.2% vs. 42.3%, P < 0.001), and there was no significant difference in the rate of severe maternal morbidity between the two groups (30% vs. 30%, P > 0.05). Binary logistic regression analysis showed that Kiwi OmniCup system-assisted delivery reduced severe neonatal morbidity (adjusted odds ratio 0.49; 95% confidence interval 0.33-0.73) and did not increase severe maternal morbidity compared with forceps-assisted delivery. CONCLUSION: The Kiwi OmniCup system, which can reduce the incidence of severe neonatal morbidity without increasing the incidence of serious adverse maternal outcomes, is worthy of clinical promotion.

Exploring the reporting standards of RCTs involving invasive procedures for assisted vaginal birth: A systematic review.

OBJECTIVE: Assisted vaginal birth (AVB) is a complex intervention involving medical devices, comprising multiple components. This complexity creates difficulties when designing and conducting randomised controlled trials (RCTs), in terms of describing, standardising and monitoring the intervention, and accounting for differing clinician expertise. This review examines the reporting standards of complex interventions involving a medical device, in the context of AVB RCTs. STUDY DESIGN: Searches were undertaken from the start of indexing to March 2021, and limited to RCTs, feasibility and pilot studies including at least one device for AVB. RCTs were selected if they included participants having an AVB with any device, with or without a comparator group. Reporting details were assessed according to the Consolidating Standards of Reporting Trials extension for non-pharmacological treatments (CONSORT-NPT), focusing on intervention descriptions, standardization, adherence and clinician expertise. Screening of abstracts, full-text articles and data extraction was performed by two independent reviewers. RESULTS: Of 4098 abstracts and 83 full-text articles, 39 papers were included, investigating 80 interventions. Twenty-seven different named devices were identified. Intervention descriptions were provided in 20 (55%) papers with varying levels of detail and with only one covering the entire procedure. Standardization of interventions was mentioned in 25 papers (64%). Only eight (21%) papers reported any form of adherence to the intended procedure. Some data regarding expertise were reported in 25 (64%) papers. CONCLUSIONS: Despite some compliance with reporting standards, there is a lack of detail regarding intervention description, standardization, adherence and expertise in RCTs of AVB. This creates difficulties in understanding how intervention delivery was intended and what actually occurred. Clearer guidelines for the reporting of invasive procedures and devices are required.

The Odon Device™ for assisted vaginal birth: a feasibility study to investigate safety and efficacy-The ASSIST II study.

BACKGROUND: The Odon Device™ is a new device for assisted vaginal birth that employs an air cuff around the fetal head for traction. Assisted vaginal birth (AVB) is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for AVB (forceps and ventouse) are often not used in settings where there is most clinical need often due to lack of training and resources, resulting in maternal and neonatal morbidity and mortality which could have been prevented. This is often due to a lack of trained operators as well as difficulties in the sterilisation and maintenance of AVB devices. This novel, single use device has the potential to mitigate these difficulties as it is single use and is potentially simpler to use than forceps and ventouse. All the studies of the Odon Device to date (pre-clinical, preliminary developmental and clinical) suggest that the Odon Device does not present a higher risk to mothers or babies compared to current standard care, and recruitment to intrapartum research exploring the device is feasible and acceptable to women. The first study in which the Odon Device was used in clinically indicated conditions (the ASSIST Study) reported a lower efficacy than those reported with established devices. The reasons need to be explored, specifically focussing on learning curve, the technique of the doctors using this new device and potential modifications to device design. A follow-on clinical study to further investigate the efficacy and safety of the Odon Device in its indicated use, the ASSIST II Study, is therefore being undertaken. METHODS: The primary feasibility outcome is study feasibility (recruitment and retention rates) whilst the primary clinical outcome successful vaginal birth completed with the Odon Device. Key secondary feasibility outcomes include participant withdrawal, compliance in data collection and acceptability of the device to women and operators. Secondary clinical outcomes include maternal, neonatal and device outcomes. Safety data will be reviewed following every birth exploring maternal, neonatal and device risks. Using A'Hern approach for sample size calculation, we aim to recruit 104 women requiring an assisted vaginal birth for a recognised clinical indication. Assuming an AVB success rate of 65% or more, a one-sided alpha risk of 5% and power of 90%. DISCUSSION: The data from the ASSIST II Study will provide the information required regarding acceptability, recruitment, outcome data collection, device design, technique of device use and operator learning curve in order to design a future randomised controlled trial of the Odon Device versus current modes of assisted vaginal birth. TRIAL REGISTRATION: ISRCTN registration: 38829082 (prospectively registered July 26, 2019).

Exploring standardisation, monitoring and training of medical devices in assisted vaginal birth studies: protocol for a systematic review.

INTRODUCTION: Assisted vaginal birth (AVB) can markedly improve maternal and neonatal outcomes arising from complications in the second stage of labour. Historically, both forceps and ventouse devices have been used to assist birth; however, they are not without risk and are associated with complications, such as cephalohaematoma, retinal haemorrhage and perineal trauma. As new devices are developed to overcome the limitations of existing techniques, it is necessary to establish their efficacy and effectiveness within randomised controlled trials (RCTs). A major challenge of evaluating complex interventions (ie, invasive procedures/devices used to assist vaginal birth) is ensuring they are delivered as intended. It can be difficult to standardise intervention delivery and monitor fidelity, and account for the varying expertise of clinicians (accoucher expertise). This paper describes the protocol for a systematic review aiming to investigate the reporting of device standardisation, monitoring and training in trials evaluating complex interventions, using AVB as a case study. METHODS AND ANALYSIS: Relevant keywords and subject headings will be used to conduct a comprehensive search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and ClinicalTrials.gov, for RCTs and pilot/feasibility studies evaluating AVB. Abstracts will be screened and full-text articles of eligible studies reviewed for inclusion. Information relating to the following categories will be extracted: standardisation of device use (ie, descriptions of operative steps, including mandatory/flexible parameters), monitoring of intervention delivery (ie, intervention fidelity, confirming that an intervention is delivered as intended) and accoucher expertise (ie, entry criteria for participation, training programmes and previous experience with the device). Risk of bias of included studies will be assessed. ETHICS AND DISSEMINATION: Ethical approval is not required because primary data will not be collected. Findings will be disseminated by publishing in a peer-reviewed journal and presentations at relevant conferences.