Which type of forceps is better for nonrotational operative births? A simulation study comparing Thierry spatulas and Simpson-Braun and Kielland forceps.

OBJECTIVE: Obstetric forceps play an important role in safe childbirth, yet there is a lack of distinction between various forceps types in clinical practice. This study aimed to evaluate and compare perineal pressure and forces on the baby during nonrotational forceps-assisted births using Simpson-Braun forceps, Kielland forceps, and Thierry spatulas on a simulation model. METHODS: This experimental study involved six obstetricians conducting 108 forceps-assisted births on a simulation model. Instruments were assessed for their impact on perineal pressure, traction force, and operator-assessed difficulty. RESULTS: Thierry's spatulas exerted the lowest force on the baby, while Kielland forceps exhibited the lowest perineal pressure, though not statistically significant. An experienced obstetrician demonstrated less perineal pressure with Simpson forceps. Notably, no significant differences in difficulty were observed between instruments. CONCLUSION: This study highlights distinctions in forceps performance, with Thierry spatulas applying the least force on the fetal head, while an experienced obstetrician fared better with Simpson forceps in terms of perineal pressure. Kielland forceps remain a viable alternative for nonrotational forceps births, showing comparable outcomes.

The use of intrapartum ultrasound in operative vaginal birth: a retrospective cohort study.

BACKGROUND: Poor outcomes from operative vaginal birth have been associated with failure to recognize malposition, breakdown in interdisciplinary communication, and deviation from accepted guidelines. We recently implemented a safety bundle including routine intrapartum ultrasound and a structured time-out and procedural checklist aiming to reduce maternal and perinatal morbidity from operative vaginal birth. OBJECTIVE: This study aimed to compare births where intrapartum ultrasound was used and those where it was not used during a safety bundle implementation period at Monash Health. STUDY DESIGN: We performed a retrospective cohort study at Monash Health during the transitional phase of implementing an operative vaginal birth safety bundle. We studied all women with operative vaginal birth and fully dilated cesarean delivery with a singleton cephalic term fetus. We compared births for which intrapartum ultrasound was used and those for which it was not. The primary outcome was neonates delivered in an unexpected position. Neonatal and maternal morbidity were also assessed, including a neonatal composite of Apgar score <7 at 5 minutes, cord lactate >8 mmol/L, need for resuscitation, significant birth trauma, or neonatal intensive care unit admission. To control for confounding by indication, we estimated propensity scores for the probability of using intrapartum ultrasound for each case based on maternal and labor characteristics, and adjusted the effect estimates for the propensity scores using multivariable logistic regression models. RESULTS: From August 2022 to July 2023, there were 1205 operative vaginal births or fully dilated cesarean deliveries at Monash Health, including 743 (61.7%) forceps, 346 (28.7%) vacuum, and 116 (9.6%) fully dilated cesarean deliveries. Over this time, we observed increased uptake of intrapartum ultrasound from 26% in August 2022 to 60% (P<.001) in July 2023, of the time-out from 21% to 58% (P<.001), and the checklist from 33% to 80% (P<.001) of operative second-stage births. Among the births where intrapartum ultrasound was used (n=509), compared with those where it was not (n=696), there were significantly more forceps births (67% vs 58%; adjusted odds ratio, 1.35; 95% confidence interval, 1.05-1.74; P=.021) and a reduction in vacuum births (24% vs 32%; adjusted odds ratio, 0.77; 95% confidence interval, 0.58-1.01; P=.059). There were no significant differences in fully dilated cesarean delivery or maternal morbidity. Intrapartum ultrasound use was associated with significantly fewer infants being delivered in an unexpected position (0.2% vs 2.2%; adjusted odds ratio, 0.08; 95% confidence interval, 0.00-0.44; P=.019) and a significant reduction in composite neonatal morbidity (22% vs 25%; adjusted odds ratio, 0.73; 95% confidence interval, 0.54-0.97; P=.031). CONCLUSION: During the implementation of a safety bundle, the use of ultrasound before operative vaginal birth was associated with fewer infants delivered in an unexpected position and reduced neonatal morbidity.

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.

Variation in Episiotomy Use Among Nulliparous Individuals by Maternity Care Provider and Associated Rates of Obstetric Anal Sphincter Injury.

OBJECTIVES: To quantify variation in the association between episiotomy and obstetric anal sphincter injury (OASI) by maternity care provider in spontaneous and operative vaginal deliveries (SVDs and OVDs). METHODS: Population-based retrospective cohort study of vaginal, term deliveries among nullipara in Canada (2004-2015). Adjusted rate ratios (ARRs) and 95% CIs were estimated using log-binomial regression to quantify the associations between episiotomy and OASI, stratified by care provider (obstetrician [OB], family physician [FP], or registered midwife [RM]) while adjusting for potential confounders. RESULTS: The study included 631 642 deliveries. Episiotomy use varied by provider: among SVDs, the episiotomy rate was 19.6%, 14.4%, and 8.4% in the OB, FP, and RM groups, respectively. The rate of OASI was higher among SVDs with versus without episiotomy (5.8% vs 4.6%). Conversely, OASI occurred less frequently in operative vaginal deliveries with episiotomy (15.3%) compared with those without (16.7%). In all provider groups, the ARR for OASI was increased with episiotomy in SVD and decreased with episiotomy with forceps delivery. No differences in these associations were observed by provider except among vacuum delivery (ARR with episiotomy vs. without, OB: 0.88, 95% CI 0.84-0.92; FP: 0.89, 95% CI 0.83-0.96, RM: 1.22, 95% CI 1.02-1.48). CONCLUSIONS: In nullipara, irrespective of maternity care provider, there is a positive association between episiotomy and OASI among SVDs and an inverse association between episiotomy and deliveries with forceps. The relationship between episiotomy and OASI is modified by maternity care providers among vacuum deliveries.

Consent Practices for Assisted Vaginal Births (AVB) at Two Tertiary Care Hospitals: A Retrospective Review of Physician Documentation.

OBJECTIVE: To determine whether assisted vaginal birth (AVB) consent documentation, a surrogate for in vivo consent, aligns with Canadian practice guidelines at 2 Canadian tertiary-level obstetric centres. METHODS: This was a retrospective review of AVBs (vacuum and forceps) from July 2019 to December 2019 at 2 tertiary-level hospitals with template-based (Site 1) or dictation-based (Site 2) documentation. We extracted, from obstetric and neonatal charts, AVB type, physician and documenter types (resident/fellow/family doctor/generalist obstetrics and gynecology [OBGYN]/maternal-fetal medicine), and consent elements (present/absent) based on a predetermined checklist. Data were summarized and comparisons were made using chi-square test, Fisher exact test, and logistic regression, where appropriate. RESULTS: We identified 551 AVBs (156 forceps, 395 vacuum) with most documentation completed by generalist OBGYNs or residents (333/551, 60.5%). Most vacuum-assisted deliveries documented no specific maternal (366/395, 92.7%) or neonatal (364/395, 92.2%) risks, and 107/156 (68.6%) and 106/156 (67.9%) forceps-assisted deliveries lacked specific documentation of maternal and neonatal risk, respectively. At Site 2, postpartum hemorrhage risk at vacuum-assisted deliveries was more commonly documented (6/90 [6.7%] vs. 2/395 [0.7%], P = 0.002) as was at least 1 neonatal risk and risk of obstetrical anal sphincter injury at forceps-assisted deliveries (50/133 [37.6%] vs. 0/23 [0%], P < 0.001) and (43/133 [32.3%] vs. 0/23 [0%], P = 0.001), respectively. CONCLUSIONS: Opportunity to improve AVB consent documentation exists, warranting quality improvement initiatives.

"Assisted vaginal birth using the Paily obstetric forceps vs Ventouse - A randomized clinical trial".

OBJECTIVE: Instruments used in assisted vaginal birth have seen little innovation for decades. Due to the risk of trauma and technical difficulty incurred during forceps delivery, instrumental deliveries are on a decline, and the global rate of primary cesarean birth is rising. The novel Paily Obstetric Forceps (POF) features a compact, lighter design with thinner blades, designed to increase operator comfort and minimize maternal and neonatal injuries. We aim to determine the feasibility and safety of POF in achieving vaginal birth compared to a ventouse device with a 50 mm silastic cup. STUDY DESIGN: We conducted a single-blinded, parallel arm, randomized clinical trial of the novel POF vs a ventouse device, in patients undergoing indicated assisted vaginal birth, at a tertiary care obstetric unit. We randomized 100 patients to be allocated on a 1:1 ratio to both intervention arms. Primary outcome was the proportion of successful instrumental deliveries. Secondary outcomes were the number of pulls required during traction and any maternal or neonatal adverse events. RESULTS: The POF was significantly more successful in achieving vaginal birth than the ventouse device (n = 50/50, 100 % vs n = 42/50, 84 %, p = 0.006). Operators reported requiring significantly fewer pulls during POF traction than ventouse. POF demonstrated a higher risk for maternal trauma (RR = 3.2, 95 % CI = 1.5 to 6.9, NNH = 2.7) but a lower risk for neonatal injury (RR = 0.6, 95 % CI = 0.3 to 1, NNH = 5.7). Maternal and neonatal recovery durations were comparable. There were no incidences of maternal or neonatal mortality. CONCLUSION: The POF can be used in indicated assisted vaginal birth with superior success rates and better neonatal outcomes than ventouse. Other obstetric forceps must be standardized to conduct larger superiority trials of forceps designs.

Influence of introducing a maneuverable vacuum extractor cup on maternal hospital stay after instrumental birth. Retrospective cohort study / Repercusión de la introducción de la ventosa obstétrica maniobrable en un centro hospitalario sobre la estancia materna tras parto instrumental. Estudio de cohortes retrospectivo

Objectives: The aim of our study is to evaluate the impact of the introduction of a maneuverable vacuum extractor cup on the length of hospital stay after assisted vaginal birth in nulliparous women in a hospital where no vacuum devices were used. Methods: This single center retrospective analytical study included two groups of nulliparous women who had undergone an assisted vaginal birth. The 2 groups differ according to the availability or not of a maneuverable vacuum extractor cup. The first group includes the last 54 instrumental births until May 2017, when only obstetric forceps and Thierry's spatulas were available in our center; the second group includes the first 54 instrumental births since May 2018 in our center, when obstetric forceps, Thierry's spatulas and maneuverable vacuum extractor cup were available. Maneuverable vacuum extractor cups had been available for 12 months in the second group. Results: In the no vacuum cup group, Kjelland forceps and Thierry's spatulas were used in 29 (53.7%) and 25 (46.3%) of the 54 assisted vaginal births, respectively. In the vacuum available group, a vacuum cup was chosen in 30 (55.6%), Kjelland forceps were used in 18 (33.3%) and Thierry's spatulas in 6 (11.1%) of the assisted vaginal births. 22 women (40.7%) had a postpartum hospital stay longer than 3 days in the group with no maneuverable vacuum extractor cup availability, versus 3 women (5.6%) in the group with availability of a maneuverable vacuum extractor cup, p<0.001. Average postpartum hospital stay length was 3.17±0.803 days versus 2.81±0.585, p<0.001. There was also a significant reduction in the number of episiotomies. Conclusion: The introduction of a maneuverable vacuum extractor cup in a center where only forceps and Thierry's spatulas had been used resulted in a decrease in postpartum hospital stay in nulliparous women.(AU)

Objetivos: El objetivo de nuestro estudio es evaluar el impacto de la introducción de una ventosa obstétrica con cazoleta maniobrable en la duración de la estancia hospitalaria tras parto instrumental en mujeres nulíparas en un hospital donde no se utilizaban ventosas obstétricas. Métodos: Este estudio de cohortes retrospectivo unicéntrico incluyó 2 grupos de mujeres nulíparas sometidas a parto instrumental. Los 2 grupos se diferencian según la disponibilidad o no de ventosa obstétrica en el centro. El primer grupo se compone de las últimas 54 mujeres a las que se les asistió un parto instrumental hasta mayo del 2017, cuando solo había disponibilidad de fórceps obstétricos y espátulas de Thierry en nuestro centro; el segundo grupo se compone de las primeras 54 mujeres a las que se les asistió un parto instrumental desde mayo del 2018 en nuestro centro, cuando había disponibilidad de fórceps obstétricos, de espátulas de Thierry y de ventosa obstétrica con cazoleta maniobrable (esta última desde hacía 12 meses). Resultados: En el grupo sin disponibilidad de ventosa obstétrica, se utilizaron fórceps de Kjelland y espátulas de Thierry en 29 (53,7%) y 25 (46,3%) de los 54 partos instrumentales, respectivamente. En el grupo con disponibilidad de ventosa, se usó la ventosa en 30 (55,6%), fórceps de Kjelland en 18 (33,3%) y espátulas de Thierry en 6 (11,1%) de los partos instrumentales; 22 mujeres (40,7%) tuvieron una estancia hospitalaria tras el parto mayor de 3 días en el grupo sin disponibilidad de ventosa, frente a 3 mujeres (5,6%) en el grupo con disponibilidad de ventosa, p<0,001. La duración media de la estancia hospitalaria tras el parto fue de 3,17±0,803 días frente a 2,81±0,585, p<0,001. También hubo una reducción significativa en el número de episiotomías.(AU)

Rapid Cycle Deliberate Practice Versus Traditional Simulation to Improve Resident Performance in Forceps Deliveries.

This study aimed to assess the effectiveness of rapid cycle deliberate practice (RCDP) in improving obstetrics and gynaecology residents' performance and skill retention in forceps-assisted vaginal deliveries. Thirty-three residents were randomly assigned to RCDP or traditional debriefing. Performance was evaluated using an objective structured assessment of technical skills (OSATS) tool. There were no significant differences in immediate performance scores between groups (P = 0.082). At 4-6 months, both groups demonstrated improved performance scores (traditional, P = 0.001; RCDP, P = 0.001). Seventy-six percent of residents in the RCDP group indicated "real-time" feedback was advantageous. Three residents suggested this method was less beneficial at a senior level.

Survey of Mode of Delivery and Maternal and Perinatal Outcomes in Canada.

OBJECTIVE: To identify determinants of cesarean delivery (CD) and examine associations between mode of delivery (MOD) and maternal and perinatal outcomes. METHODS: We conducted a retrospective analysis of a Canadian multicentre birth cohort derived from provincial data collected in 2008/2009. Maternal and perinatal characteristics and outcomes were compared between vaginal and cesarean birth and between the following MOD subgroups: spontaneous vaginal delivery (VD), assisted VD, planned cesarean delivery (CD), and intrapartum CD. Multivariate regression identified determinants of CD and the effects of MOD and previous CD on maternal and perinatal outcomes. RESULTS: The cohort included 264 755 births (72.1% VD and 27.9% CD) from 91 participating institutions. Determinants of CD included maternal age, parity, previous CD, chronic hypertension, diabetes, urinary tract infection or pyelonephritis, gestational hypertension, vaginal bleeding, labour induction, pre-term gestational age, low birth weight, large for gestational age, malpresentation, and male sex. CD was associated with greater risk of maternal and perinatal morbidity and mortality. Subgroup analysis demonstrated higher risk of adverse pregnancy outcomes with assisted VD and intrapartum CD than spontaneous VD. Planned CD reduced the risk of obstetric wound hematoma and perinatal mortality but increased maternal and neonatal morbidity. Previous CD increased the risk of maternal and neonatal morbidity among multiparous women. CONCLUSIONS: The CD rate in Canada is consistent with global trends reflecting demographic and obstetric intervention factors. The risk of adverse pregnancy outcomes with CD warrants evaluation of interventions to safely prevent nonessential cesarean birth.

Coincidental finding of a giant bladder calculus and squamous cell carcinoma of bladder: A case report.

Chronic irritation of bladder by urinary bladder calculus is a known risk factor for bladder cancer. The use of Wrigley's obstetrical forceps in general surgical practice is a rare event. Herein, we report a case of a giant urinary bladder calculus which was removed by Wrigley's obstetrical forceps during open cystolithotomy. The bladder biopsy showed squamous cell carcinoma of the bladder. With this report, we aim to create an awareness among surgeons about the role of the Wrigley's obstetrical forceps during open cystolithotomy, and the role of taking urinary bladder biopsy from chronically inflamed/unhealthy sites.

Patient Satisfaction with Informed Consent for Cesarean and Operative Vaginal Delivery.

OBJECTIVE: To evaluate patient satisfaction with the informed consent process for elective cesarean delivery (CD), emergency CD, and operative vaginal delivery (OVD). METHODS: A cross-sectional, survey-based study was conducted among patients on the postpartum floor of our institution. Patients were approached after delivery to complete a previously pilot-tested questionnaire, based on validated literature. One hundred eighty-four surveys were included in the analysis. Levels of patient satisfaction were compared across modes of delivery using χ2 tests of independence. Secondary objectives included evaluating the relationship between satisfaction scores and the patient's recall of the consent process and emotional state during the consent process. RESULTS: A significant association was found between patient satisfaction with the consent process and mode of delivery (P < 0.001). Those in the elective and emergency CD groups were significantly more likely to express high rates of satisfaction compared with those in the OVD group (odds ratio [OR] 9.03; 95% CI 2.80-29.10 and OR 3.97; 95% CI 1.34-11.76, respectively). High levels of satisfaction were significantly more common among those who had greater recall of the consent process (OR 25.2; 95% CI 7.34-87.04) and those who reported low levels of distress during the process (OR 15.1; 95% CI 4.70-48.66). CONCLUSION: Informed consent during OVD is associated with lower rates of patient satisfaction compared with CD. Efforts are needed to improve the consent process for OVD to increase patient satisfaction and promote patient-centred care.

Identification of Essential Steps in Outlet Forceps-Assisted Vaginal Delivery: A Delphi Study.

OBJECTIVE: To achieve expert consensus using the Delphi methodology on the sub-steps considered essential in an outlet forceps-assisted vaginal delivery (FAVD). The purpose of this work is to help inform a framework for standardized training and objective assessment in the procedure. METHODS: A Delphi survey was conducted with an international panel of experts in FAVD. Using an online platform, experts rated sub-steps of FAVD on a 5-point Likert scale to indicate whether they considered them essential. Responses were returned to the panel until consensus was reached (Cronbach α ≥ 0.80) with an intraclass correlation coefficient ≥0.75. All sub-steps with a rate of agreement ≥80% are proposed to be included in a future evaluation instrument. RESULTS: After the first iteration of the Delphi procedure, a response rate of 42% was reached (n = 21); the second iteration was only sent to those who had participated in the initial iteration, reaching a response rate of 100%. Of 42 sub-steps rated in the first round, 24 (57.1%) achieved consensus, 8 (19%) were rejected, and 10 (23.8%) were re-rated in the second round. After 2 iterations, 28 sub-steps were agreed upon by the experts to be essential in FAVD. CONCLUSIONS: A panel of experts identified a total of 28 sub-steps essential to FAVD. This list could inform the development of an objective assessment framework and evaluation tool for this procedure. Further research should focus on the standardization, applicability, validation, and introduction of this tool in medical training, with a focus on real-life, high-fidelity simulation and online educational tools.

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).

An Initiative to Increase Resident Performance of Operative Vaginal Deliveries.

The objective of this single-centre, action research study was to increase resident experience performing operative vaginal deliveries. The secondary objective was to assess the incidence of maternal and neonatal complications. The rate of forceps deliveries increased in the post-training period (1.8%-4.0%; P < 0.001) but the overall rate of operative vaginal delivery did not change. The composite maternal complications rate following forceps delivery was lower in the post- training period (P = 0.006). There were no significant differences in maternal or neonatal complications with vacuum delivery between the periods before and after the initiative. Experiential training of residents may be a viable alternative to simulation training as it does not require expensive state-of-the-art simulation technology.

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.

Association of Cesarean Delivery with Childhood Hospitalization for Infections Before 13 Years of Age.

OBJECTIVES: To determine the association between cesarean delivery and childhood infections up to 13 years of age. STUDY DESIGN: We conducted a longitudinal cohort study of 731 803 children born between 2006 and 2016 at all hospitals in the province of Quebec, Canada. We followed children born by cesarean, operative vaginal, and nonoperative vaginal delivery up to 13 years of age. Outcomes included hospitalization for otitis media, respiratory, infectious enteritis, and other infections. We estimated hazard ratios with 95% CIs for the association between mode of delivery and childhood infections, adjusted for patient characteristics. RESULTS: At age 3-4 years, cesarean delivery was associated with a 1.07-fold greater risk of otitis media (95% CI, 1.03-1.11), a 1.15-fold greater risk of respiratory infection (95% CI, 1.09-1.22), and a 1.13-fold greater risk of infectious enteritis (95% CI, 1.03-1.25) compared with nonoperative vaginal delivery. However, operative vaginal delivery was associated with these same outcomes. Both cesarean and operative vaginal delivery were more strongly associated with infection hospitalization before age 1 year, but associations disappeared after 5 years. CONCLUSIONS: Cesarean delivery is associated with infection hospitalization before but not after age 5 years. However, associations were also present for operative vaginal delivery, which suggests that mechanisms other than exposure to maternal vaginal flora explain the relationship.

Análise da percepção de puérperas sobre a assistência ao parto em uma maternidade do Tocantins / Analysis of the perception of puerperal women about maternity care assistance in a maternity of Tocantins

Objetivo: No decorrer dos séculos, o parto migrou do ambiente domiciliar para o hospitalar, sendo então repleto de procedimentos que, embora tenham o intuito de ajudar, nem sempre são adequados ou baseados em evidências. Por isso, o objetivo deste estudo é identificar os procedimentos realizados com parturientes durante o parto em uma maternidade do Tocantins, além de caracterizar o perfil dessas pacientes. Método: Foi aplicado um questionário a 70 puérperas de parto normal, maiores e menores de idade, durante quatro meses. O questionário de referência foi o utilizado do estudo Nascer no Brasil. Resultados: A maioria das pacientes se autodeclarou parda, tinha ao menos o ensino médio completo e era maior de 18 anos. Mais da metade delas tiveram alguma alteração no períneo, 25% sofreram manobra de Kristeller e 88% submeteram-se à litotomia. Além disso, a grande maioria avaliou o serviço da maternidade como bom/ótimo/excelente. Conclusão: A assistência ao parto no Tocantins ainda se divide em práticas adequadas e técnicas ultrapassadas. Trata-se de um estudo original e um dos primeiros nesse sentido realizado no estado mais novo do Brasil.(AU)

Objective: Throughout the centuries, childbirth has migrated from the home environment to the hospital, being then full of procedures that although they are intended to help, are not always adequate or based on evidence. Therefore, the objective of this study is to identify the procedures performed with parturients during childbirth in a maternity hospital in Tocantins, in addition to characterizing the profile of these patients. Method: A questionnaire was applied to 70 mothers of normal birth, older and younger, for four months. The reference questionnaire was used in the Nascer no Brasil study. Results: Most patients declared themselves to be brown, had at least completed high school, and were over 18 years old. More than half of them had some alteration in the perineum, 25% underwent a Kristeller maneuver and 88% underwent lithotomy. In addition, the vast majority rated the maternity service as good/excellent/excellent. Conclusion: Assistance to childbirth in Tocantins is still divided into outdated technical and appropriate practices. This is an original study and one of the first in this sense carried out in the newest state of Brazil.(AU)

No. 148-Guidelines for Operative Vaginal Birth.

OBJECTIVE: To provide guidelines for operative vaginal birth in the management of the second stage of labour. OPTIONS: Non-operative techniques, episiotomy, and Caesarean section are compared to operative vaginal birth. OUTCOME: Reduced fetal and maternal morbidity and mortality. EVIDENCE: MEDLINE and Cochrane databases were searched using the key words ''vacuum" and "birth" as well as "forceps" and "birth" for literature published in English from january 1970 to June 2004. The level of evidence and quality of rec-ommendations made are described using the Evaluation of Evidence from the Canadian Task Force on the Periodic Health Examination. RECOMMENDATIONS: VALIDATION: The Clinical Practice Obstetrics Committee and Executive and Council of the Society of Obstetricians and Gynaecologists of Canada approved these guidelines.

A qualitative study showing women's participation and empowerment in instrumental vaginal births.

BACKGROUND: An instrumental birth with a ventouse or forceps is a complicated birth, possibly resulting in fear of childbirth which could influence the entire birth experience negatively. Patients who are actively involved in their care have a stronger sense of satisfaction and a sense of participation can contribute to shorter hospital stays. AIM: To describe the experience of participation for women involved in an instrumental delivery with ventouse or forceps. METHOD: Qualitative semi-structured interviews with 16 women who gave birth aided by a ventouse or forceps. Their answers were analyzed through qualitative content analysis. In addition the women were asked to evaluate their experience during the delivery. Using a numerical scale (NRS) the birth experience was graded by choosing a number between 0 (worst possible experience) and 10 (best conceivable experience). FINDINGS: Two themes were extracted from the data: To be part of a team and To feel empowered. Five categories were identified from the women's descriptions of the experience of involvement during the instrumental delivery: to cooperate; to understand; to have contact; to participate, and to not be involved. Those women who rated their experience as low grade, described a lack of involvement in their childbirth compared to those women who rated their experience as high. CONCLUSION: This study shows how cooperation and empowerment of the woman are two key factors in order for the women to have a positive experience of their instrumental vaginal births. The study also shows that empowerment is created when the woman is actively engaged and participates in the birth process which gives her the feeling of being part of the team, creating an environment based on mutual understanding.