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.

The BD Odon Device™: an update of its current state.

The BD Odon Device™ was designed as an alternative to conventional methods for assisting vaginal delivery, especially in low-resource settings. This a systematic review of published data concerning the BD Odon Device™ until March 2020 listed in Pubmed, Google Scholar, SCOPUS and Web of Science.Five studies testing the device were found, three in models and two in women with uncomplicated deliveries. According to their results, the device seems easy to use, safe, effective and requires simple and fast training, so it may become a good alternative to vacuum extractor or forceps, especially in places where there is less specialised staff, low-resources settings. The study protocol of the first study in complicated second stages has already been published. There is still few information about the BD Odon Device™ in scientific literature, however more research concerning the device is expected to take place in a near future.Impact StatementWhat is already known on this subject? The Odon DeviceTM is a device under development that aims to be a useful tool to assist vaginal deliveries.What do the results of this study add? This is a review of the current state of the development of the Odon DeviceTM. Further tests in humans are planned in the future in order to evaluate its safety and efficacy.What are the implications of these findings for clinical practice and/or further research? The Odon DeviceTM may be a promising tool to assist vaginal deliveries, especially in low-resource countries and countries with high rates of C-section during second stage of labour, but further research is needed to evaluate its safety and efficacy.

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.

Evaluation of Suzor forceps training by studying obstetric anal sphincter injuries: a retrospective study.

BACKGROUND: Instrumental deliveries are an unavoidable part of obstetric practice. Dedicated training is needed for each instrument. To identify when a trainee resident can be entrusted with instrumental deliveries by Suzor forceps by studying obstetric anal sphincter injuries. METHODS: A French retrospective observational study of obstetric anal sphincter injuries due to Suzor forceps deliveries performed by trainee residents was conducted from November 2008 to November 2016 at Limoges University Hospital. Perineal lesion risk factors were studied. Sequential use of a vacuum extractor and then forceps was also analyzed. RESULTS: Twenty-one residents performed 1530 instrumental deliveries, which included 1164 (76.1%) using forceps and 89 (5.8%) with sequential use of a vacuum extractor and then forceps. Third and fourth degree perineal tears were diagnosed in 82 patients (6.5%). Residents caused fewer obstetric anal sphincter injuries after 23.82 (+/- 0.8) deliveries by forceps (p = 0.0041), or after 2.36 (+/- 0.7) semesters of obstetrical experience (p = 0.0007). No obese patient (body mass index> 30) presented obstetric anal sphincter injuries (p = 0.0013). There were significantly fewer obstetric anal sphincter injuries after performance of episiotomy (p <  0.0001), and more lesions in the case of the occipito-sacral position (p = 0.028). Analysis of sequential instrumentation did not find any additional associated risk. CONCLUSION: Training in the use of Suzor forceps requires extended mentoring in order to reduce obstetric anal sphincter injuries. A stable level of competence was found after the execution of at least 24 forceps deliveries or after 3 semesters (18 months) of obstetrical experience.

Differential effects of different delivery methods on progression to severe postpartum hemorrhage between Chinese nulliparous and multiparous women: a retrospective cohort study.

BACKGROUND: Delivery methods are associated with postpartum hemorrhage (PPH) both in nulliparous and multiparous women. However, few studies have examined the difference in this association between nulliparous and multiparous women. This study aimed to explore the difference of maternal and neonatal characteristics and delivery methods between Chinese nulliparous and multiparous women, and then examine the differential effects of different delivery methods on PPH between these two-type women. METHODS: Totally 151,333 medical records of women who gave birth between April 2013 to May 2016 were obtained from the electronic health records (EHR) in a northern province, China. The severity of PPH was estimated and classified into blood loss at the level of < 900 ml, 900-1500 ml, 1500-2100 ml, and > 2100 ml. Neonatal and maternal characteristics related to PPH were derived from the same database. Multiple ordinal logistic regression was used to estimate associations. RESULTS: Medical comorbidities, placenta previa and accreta were higher in the nulliparous group and the episiotomy rate was higher in the multiparous group. Compared with spontaneous vaginal delivery (SVD), the adjusted odds (aOR) for progression to severe PPH due to the forceps-assisted delivery was much higher in multiparous women (aOR: 9.32; 95% CI: 3.66-23.71) than in nulliparous women (aOR: 1.70; 95% CI: 0.91-3.18). The (aOR) for progression to severe PPH due to cesarean section (CS) compared to SVD was twice as high in the multiparous women (aOR: 4.32; 95% CI: 3.03-6.14) as in the nulliparous women (aOR: 2.04; 95% CI: 1.40-2.97). However, the (aOR) for progression to severe PPH due to episiotomy compared to SVD between multiparous (aOR: 1.24; 95% CI: 0.96-1.62) and nulliparous women (aOR: 1.55; 95% CI: 0.92-2.60) was not significantly different. The (aOR) for progression to severe PPH due to vacuum-assisted delivery compared to SVD in multiparous women (aOR: 2.41; 95% CI: 0.36-16.29) was not significantly different from the nulliparous women (aOR: 1.05; 95% CI: 0.40-2.73). CONCLUSIONS: Forceps-assisted delivery and CS methods were found to increase the risk of severity of the PPH. The adverse effects were even greater for multiparous women. Episiotomy and the vacuum-assisted delivery, and SVD were similar to the risk of progression to severe PPH in either nulliparous or multiparous women. Our findings have implications for the obstetric decision on the choice of delivery methods, maternal and neonatal health care, and obstetric quality control.

Operative Vaginal Birth of a Critically Endangered Gorilla With Forceps Assistance.

BACKGROUND: An obstetrician on standby assessed an 18-year-old primiparous captive gorilla with a term singleton fetus with a protracted labor course. CASE: After it was determined that an arrest of descent had occurred, a viable, 2,280 g male neonate was delivered through an operative vaginal birth with forceps assistance without major complications. CONCLUSION: Given the numerous anatomic and biochemical similarities of humans and other great apes, it is possible that the high maternal mortality and stillbirth rates of gorillas could be reduced by using the same principles of obstetric management in a multidisciplinary fashion.

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.

Duration of Operative Vaginal Delivery and Adverse Obstetric Outcomes.

OBJECTIVE: This study aimed to evaluate whether the number of vacuum pop-offs, the number of forceps pulls, or the duration of operative vaginal delivery (OVD) is associated with adverse maternal and perinatal outcomes. STUDY DESIGN: This is a secondary analysis of a multicenter observational cohort of women who underwent an attempted OVD. Women were stratified by the duration of OVD and the number of pop-offs (vacuum) or pulls (forceps) attempted. Severe perineal lacerations, failed OVD, and a composite adverse neonatal outcome were compared by the duration of OVD and number of pop-offs or pulls. RESULTS: Of the 115,502 women in the primary cohort, 5,325 (4.6%) underwent an attempt at OVD: 3,594 (67.5%) with vacuum and 1,731 (32.5%) with forceps. After adjusting for potential confounders, an increasing number of pop-offs was associated with an increased odds of the composite adverse neonatal outcome. However, an increasing duration of vacuum exhibited a stronger association with the composite adverse neonatal outcome. Similarly, the number of forceps pulls was less strongly associated with the composite adverse neonatal outcome compared with the duration of forceps application. CONCLUSION: The duration of OVD may be more associated with adverse neonatal outcomes than the number of pop-offs or pulls.

Advanced technology in obstetric education: a high-fidelity simulator for operative vaginal delivery.

A high-fidelity simulator is described here, specifically designed for vacuum extraction and forceps delivery training. The main purpose behind its development is to remedy the current limited opportunity for training in operative vaginal delivery (OVD), making it easier for young obstetricians to become proficient in this important area of obstetrics. Its introduction into teaching hospitals and academic departments may also help older obstetricians maintain their own competence during periods of inactivity, ensuring patient safety.

The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study.

BACKGROUND: Assisted vaginal birth 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 assisted vaginal birth (forceps and ventouse) are often not utilised in settings where there is most clinical need, resulting in maternal and neonatal morbidity and mortality which could have been prevented. The BD Odon Device is a new device for assisted vaginal birth that may be able to address this unmet need. However, before dissemination, the device requires evaluation in robust clinical trials. A feasibility study to investigate the clinical impact, safety, and acceptability of the BD Odon Device for assisted vaginal birth is therefore planned. This will provide further information on acceptability, recruitment, and the outcome data required to design a future randomised controlled trial of the BD Odon Device versus Kiwi ventouse. METHODS: Forty women who require an assisted vaginal birth for a recognised clinical indication will have the birth assisted with the BD Odon Device. The primary outcome is successful vaginal birth completed with the BD Odon Device. Secondary clinical outcomes include maternal and neonatal outcomes, and maternal and practitioner satisfaction. Safety data will be reviewed following every birth. DISCUSSION: A future randomised controlled trial of the BD Odon Device versus the current standard instrument (the Kiwi ventouse) is planned. The findings of the ASSIST Study will inform the randomised controlled trial design. TRIAL REGISTRATION: ISRCTN, ISRCTN10203171 . Prospectively registered on 27 July 2018.

The impact of variations in obstetric practice on maternal birth trauma.

INTRODUCTION AND HYPOTHESIS: Forceps delivery and length of second stage are risk factors of maternal birth trauma, i.e., levator ani muscle (LAM) avulsion and anal sphincter trauma. The cesarean section (CS) rate has recently become the key performance indicator because of its increase worldwide. Attempts to reduce CS rates seem to have led to an increase in forceps deliveries and longer second stages. This study aimed to determine the association between variations in obstetric practice (between hospitals) and maternal birth trauma. METHODS: This was a retrospective ancillary analysis involving 660 nulliparous women carrying an uncomplicated singleton term pregnancy in a prospective perinatal intervention trial at two Australian tertiary obstetric units. They had been seen antenatally and at 3-6 months postpartum for a standardized clinical assessment between 2007 and 2014. Primary outcome measures were sonographically diagnosed LAM and external anal sphincter (EAS) trauma. RESULTS: The incidence of LAM avulsion (11.5% vs. 21.3%, P = 0.01) and composite trauma, i.e., LAM avulsion ± EAS injury (29.2% vs. 39.7%, P = 0.03) were higher in one of the two hospitals, where the forceps delivery rate was also higher (10.9% vs. 2.6%, P < 0.001). BMI (OR 0.9, P = 0.02), length of second stage (OR 1.01, P = 0.02) and forceps delivery (OR 5.24, P < 0.001) were significant predictors of the difference in LAM avulsion incidence between the hospitals. Maternal age (OR 1.06, P < 0.04) and forceps delivery (OR 8.66, P < 0.001) were significant predictors for composite trauma. CONCLUSIONS: A higher incidence of LAM avulsion and composite trauma in one of the two hospitals was largely explained by a higher forceps delivery rate.

A simple model to predict the complicated operative vaginal deliveries using vacuum or forceps.

BACKGROUND: Complicated operative vaginal deliveries are associated with high neonatal morbidity and maternal trauma, especially if the procedure is unsuccessful and a cesarean delivery is needed. The decision to perform an operative vaginal delivery has traditionally been based on a subjective assessment by digital vaginal examination combined with the clinical expertise of the obstetrician. Currently there is no method for objectively quantifying the likelihood of successful delivery. Intrapartum ultrasound has been introduced in clinical practice to help predict the progression and final method of delivery. OBJECTIVE: The aim of this study was to compare predictive models for identifying complicated operative vaginal deliveries (vacuum or forceps) based on intrapartum transperineal ultrasound in nulliparous women. STUDY DESIGN: We performed a prospective cohort study in nulliparous women at term with singleton pregnancies and full dilatation who underwent intrapartum transperineal ultrasound evaluation prior to operative vaginal delivery. Managing obstetricians were blinded to the ultrasound data. Intrapartum transperineal ultrasound (angle of progression, progression distance, and midline angle) was performed immediately before instrument application, both at rest and concurrently with pushing. Intrapartum evaluation of fetal biometric parameters (estimated fetal weight, head circumference, and biparietal diameter) was also carried out. An operative vaginal delivery was classified as complicated when 1 or more of the following complications occurred: ≥3 tractions needed; third- to fourth-degree perineal tear; severe bleeding during episiotomy repair (decrease of ≥2.5 g/dL in the hemoglobin level); or significant traumatic neonatal lesion (subdural-intracerebral hemorrhage, epicranial subaponeurotic hemorrhage, skeletal injuries, injuries to spine and spinal cord, or peripheral and cranial nerve injuries). Six predictive models were evaluated (information available in Table 2). RESULTS: We recruited 84 nulliparous patients, of whom 5 were excluded because of the difficulty of adequately evaluating the biparietal diameter and head circumference. A total of 79 nulliparous patients were studied (47 vacuum deliveries, 32 forceps deliveries) with 13 cases in the occiput-posterior position. We identified 31 cases of complicated operative vaginal deliveries (19 vacuum deliveries and 12 forceps deliveries). No differences were identified in obstetric, neonatal, or intrapartum characteristics between the 2 study groups (operative uncomplicated vaginal delivery vs operative complicated vaginal delivery), with the following exceptions: estimated fetal weight (3243 ± 425 g vs 3565 ± 330 g; P = .001), biparietal diameter (93.2 ± 2.1 vs 95.2 ± 2.3 mm; P = .001), head circumference (336 ± 12 vs 348 ± 6.4 mm; P = .001), sex (female 62.5% vs 29.0%; P = .010), newborn weight (3258 ± 472 g vs 3499 ± 383 g; P = .027), and number of tractions (median, interquartile range) (1 [1-2] vs 4 [3-5]; P < .0005). To predict complicated operative deliveries, all 6 of the studied models presented an area under the receiver-operating characteristics curve between 0.863 and 0.876 (95% confidence intervals, 0.775-0.950 and 0.790-0.963; P < .0005). The results of the study met the criteria of interpretability and parsimony (simplicity), allowing us to identify a binary logistic regression model based on the angle of progression and head circumference; this model has an area under the receiver-operating characteristics curve of 0.876 (95% confidence interval, 0.790-0.963; P < .0005) and a calibration slope B of 0.984 (95% confidence interval, 0.0.726-1.243; P < .0005). CONCLUSION: The combination of the angle of progression and the head circumference can predict 87% of complicated operative vaginal deliveries and can be performed in the delivery room.

Single prior caesarean section and risk of anal sphincter injury.

INTRODUCTION AND HYPOTHESIS: Injury to the anal sphincter at vaginal delivery remains the leading cause of faecal incontinence in women. Previous studies reported an increased incidence of obstetric anal sphincter injury (OASI) in women attempting vaginal birth after caesarean section (VBAC). The aim of the paper was to establish whether women in their second pregnancy, with one previous uterine scar, are at a higher risk of OASI compared with nulliparous women. METHODS: All primiparous and secundiparous women with a previous caesarean section who delivered from 2008 to 2017 were analysed in a single-centre retrospective study. The primary endpoint was OASI. Labour characteristics in both groups were compared, and a multiple regression model was created. RESULTS: There were 8573 vaginal deliveries of nulliparous women and 3453 deliveries of women in their second pregnancy with a previous caesarean section, of whom 550 had a successful VBAC. There was no significant difference in the rate of OASI between primiparous women and those who had a successful VBAC: 3.5% (297/8573) versus 3.1% (17/550), P = 0.730). Foetal macrosomia (>4 kg) and forceps delivery were risk factors for sphincter injury, while episiotomy and epidural anaesthesia were protective. CONCLUSIONS: VBAC does not confer an increased risk of OASI after a first delivery by caesarean section when compared with nulliparous women. The rate of successful VBAC may be contributory and suggests that the risk conferred by VBAC may be unit-specific. Unit and national-level audit is necessary to investigate this risk further.

Video-Based Teaching in Patient and Instrument Selection for Operative Vaginal Deliveries.

OBJECTIVE: Worldwide, the rate of operative vaginal deliveries has decreased, and as a result trainees are lacking exposure and training. The aim of this study was to determine whether a video-based masterclass can improve trainees' confidence, comfort, and knowledge in performing second stage labour assessments and selecting appropriate patients and instruments for operative vaginal deliveries. METHODS: Current University of Toronto obstetrics and gynaecology residents were invited to participate. The intervention included two videos on second stage assessment: (1) selecting the appropriate patient and (2) selecting the appropriate instrument for an operative vaginal delivery. Trainees' comfort and confidence were assessed pre- and post-intervention. A focus group was conducted that assessed trainees' knowledge acquisition. Descriptive thematic analysis was performed, and common themes were extracted. RESULTS: On average, residents have performed more vacuum deliveries than forceps deliveries as primary operators (26.4 vs. 7.9). Following the video intervention, there was a statistically significant improvement (P ≤ 0.05) in trainees' comfort in the following areas: (1) understanding the maternal pelvis, (2) choosing instruments, (3) choosing forceps, (4) deciding the location of delivery, (5) identifying favourable clinical factors, and (6) identifying poor prognostic clinical factors. There was no difference in trainees' self-confidence. Major themes from focus group data included new knowledge gained on second stage assessment techniques, new approaches to existing knowledge, and the multiple challenges and barriers that exist to learning. CONCLUSION: Video-based education on second stage labour assessment and operative vaginal delivery improves trainees' comfort and serves as a valuable complementary tool to clinical learning.

A review of randomized trials comparisons of epidural with parenteral forms of pain relief during labour and its impact on operative and cesarean delivery rate.

OBJECTIVES: The aim of this review was to summarise the available literature on different modalities of labour pain relief (epidural vs. parenteral) and to assess their impact on the rate of caesarean section deliveries and instrumental deliveries, and on the need to support the uterine contractile function. MATERIAL AND METHODS: The PubMed, Web of Science and Cochrane databases were reviewed to identify articles describing the effect of labour pain relief on the course of labour. This review includes 16 studies with 7150 patients. RESULTS: The analysis of the obtained data revealed that epidural analgesia (EA) or combined epidural and spinal anaesthesia (CESA) provided significantly better labour pain relief when compared with parenteral opioids. Conduction anaesthesia was not associated with an increase in the caesarean section delivery rate. Some authors concluded that conduction anaesthesia was associated with the need for assisted delivery. CONCLUSIONS: Epidural analgesia is a well-recognised method of labour pain relief. It is associated with the parturient's higher satisfaction when compared to parenteral opioids. EA does not directly increase the caesarean section delivery rate, yet it can lead to instrumental deliveries (vacuum-assisted, obstetrics forceps) and a need to pharmacologically support the uterine contractile function. Further studies are required to evaluate the effect of EA on the course of labour, and methods of minimising its adverse effects.

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.

BACKGROUND: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. RESULTS: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. CONCLUSIONS: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. TRIAL REGISTRATION: ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

Uso del balón cervical vs. prostaglandinas endocervicales para la inducción del parto en embarazo a término: revisión breve de literatura / Use of the cervical balloon vs. endocervical prostaglandins for the induction of labor in term pregnancy: literature brief review / Usando a bola cervical vs prostaglandinas endocervicais para indução do parto em gestação a termo: breve revisão da literatura

ResumenLas prácticas del cuidado del embarazo y el parto varían ampliamente entre los países, las instituciones y los diferentes equipos encargados del cuidado obstétrico: en este contexto con prácticas tan diversas, la práctica clínica basada en la evidencia permite que el accionar de los profesionales encargados del cuidado obstétrico se fundamente en la mejor evidencia disponible. El objetivo del presente estudio es analizar la mejor evidencia científica disponible sobre los efectos adversos del uso del balón cervical durante y posterior a la labor de parto, en comparación con el uso de prostaglandinas endocervicales para la inducción del parto en mujeres con embarazo a término. La secuencia de etapas para la recolección de la información se inició con la aplicación del mapa de búsqueda en las bases de datos MEDLINE, PUBMED y COCHRANE LIBRARY, a partir de los siguientes criterios de filtro de información: artículos publicados entre los años 2010 al 2015, mujeres gestantes de cualquier edad, únicamente se incluyó estudios como ensayos aleatorizados controlados, revisiones sistemáticas, meta-análisis o guías de práctica clínica y de preferencia artículos científicos en idioma inglés o portugués. Esta búsqueda y análisis de la evidencia encontrada se realizó durante los meses de abril y mayo del año 2015 por dos revisores. Los resultados obtenidos para el análisis crítico fueron revisados minuciosamente a través de la plataforma informática FCL 2.0 con las plantillas de ensayo clínico y revisión sistemática incluidas en los anexos. Se concluye que la utilización del balón endocervical comparado con el uso de prostaglandinas endocervicales presenta menos efectos adversos de manera específica durante la labor del parto. En relación con los efectos adversos posteriores, no se encuentra mayor diferencia entre uno u otro método.

AbstractPregnancy and childbirth care practices vary widely across countries, institutions, and different obstetrical care teams: in this context with such diverse practices, evidence-based clinical practice allows the Obstetric care is based on the best available evidence. The objective of the present study is to analyze the best available scientific evidence on the adverse effects of cervical balloon use during and after labor, compared to the use of endocervical prostaglandins for induction of labor in women with term pregnancy. The sequence of steps for the collection of information was initiated with the application of the search map in the databases MEDLINE, PUBMED and COCHRANE LIBRARY, based on the following information filter criteria: articles published between the years 2010 to 2015, Pregnant women of any age, only included studies such as randomized controlled trials, systematic reviews, meta-analyzes or guidelines of clinical practice and preferably scientific papers in English or Portuguese. This search and analysis of the evidence found was carried out during the months of April and May of the year 2015 by two reviewers. The results obtained for the critical analysis were carefully reviewed through the FCL 2.0 computer platform with the clinical trial templates and systematic review included in the annexes. It is concluded that the use of the endocervical balloon compared to the use of endocervical prostaglandins presents less adverse effects specifically during labor. In relation to the subsequent adverse effects, no greater difference is found between one or the other method.

ResumoPráticas de cuidados a gravidez eo parto variam amplamente entre os países, instituições e diferentes equipas de cuidados obstétricos; neste contexto como práticas diversas, a prática clínica baseada em evidências permite que as ações dos profissionais responsáveis pela assistência obstétrica é baseada na melhor evidência disponível. O objetivo deste estudo é analisar a melhor evidência científica disponível sobre os efeitos adversos durante e após o parto com o uso de bola cervical em comparação com o uso de prostaglandina endocervical para indução do parto em mulheres com gravidez a termo. A sequência dos passos para a recolha de dados começa com a busca do mapa aplicação em Medline, PubMed e os dados Cochrane Library, onde os seguintes critérios de filtro de informação artigos introduzidos foram seleccionados publicação período entre 2010 e 2015, a população foi delimitada a mulheres grávidas de qualquer idade, digite apenas ensaios estudos clínicos randomizados, revisões sistemáticas, meta-análises ou diretrizes de prática clínica e artigos científicos de preferência em Inglês ou Português foram incluídos. Esta pesquisa e análise da evidência encontrada foi realizado durante os meses de Abril e Maio de 2015, dois colaboradores. Os resultados obtidos para a análise crítica foram cuidadosamente controlados através da plataforma FCL computador 2,0 modelos ensaio clínico e revisão sistemática estão incluídos nos anexos. Concluiu-se que o uso de bola endocervical em comparação com a utilização de prostaglandinas endocervicais tem menos efeitos adversos especificamente durante o trabalho de parto. Em ligação com os efeitos adversos subsequentes não é maior diferença entre qualquer um dos métodos.

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.

The role of operative vaginal birth in the 21st century and a way forward.

Effective devices and effective, validated training can improve operative vaginal birth outcomes for women and their babies. TWEETABLE ABSTRACT: Effective devices and effective, validated training can improve operative vaginal birth outcomes for women and their babies.