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OBJECTIVE: To investigate whether women undergoing their first vaginal delivery after a previous cesarean section (secundiparous) are at increased risk for obstetric anal sphincter injury (OASI) compared with primiparous women. METHODS: A retrospective cohort study of 85 428 women who delivered vaginally over a 10-year period in a single tertiary medical center. Incidence of OASI, risk factors, and clinical characteristics were compared between primiparous women who delivered vaginally and secundiparous women who underwent their first vaginal birth after cesarean section (VBAC). A multivariable logistic regression analysis was used to study the association between VBAC and OASI. RESULTS: Overall, 36 250 primiparous and 1602 secundiparous women were enrolled, 309 of whom had OASI. The rates of OASI were similar among secundiparous women who had VBAC and primiparous women who underwent vaginal delivery (15 [0.94%] vs 294 [0.81%], P = 0.58). The proportions of third- and fourth-degree tears were also similar among secundiparous and primiparous women who experienced OASI (87% vs 91.5%, and 13% vs 8.5%, respectively, P = 0.68). Furthermore, the rates of OASI were similar in both study groups, although secundiparous women who underwent VBAC had higher rates of birth weights exceeding 3500 g (414 [25.8%] vs 8284 [22.8%], P = 0.016), and higher rates of vacuum-assisted deliveries (338 [21%] vs 6224 [17.2%], P < 0.001). A multivariate logistic regression analysis failed to establish a statistically significant association between VBAC and OASI (odds ratio 0.672, 95% confidence interval 0.281-1.61, P = 0.37). CONCLUSIONS: No increased risk for OASI was found in secundiparous women who underwent VBAC compared with primiparous women at their first vaginal birth.

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OBJECTIVE: To compare maternal and fetal outcomes between early (<2 h) and delayed (>2 h) vacuum extraction (VE) deliveries. METHODS: We performed a retrospective cohort study in a single, university-affiliated medical center (2014-2021). We included term singleton pregnancies delivered by VE, allocated into one of two groups according to second stage duration: <2 h or >2 h. Primary outcome was maternal composite adverse outcome (included chorioamnionitis, 3-4 degree lacerations, and postpartum hemorrhage [PPH]). RESULTS: We included 2521 deliveries: 2261 (89.6%) with early VE and 260 (10.4%) with delayed VE. Study groups' characteristics were not different, except of parity. Maternal composite outcome almost reached a significance (P = 0.054) comparing between the groups. Comparing second stage length up to 2 h versus more, there was similar rate of advance maternal lacerations. However, extending the second stage to more than 3 h was associated with third degree lacerations compared to 2-3 h (9.8% vs 3%, P = 0.011). There were significantly more PPH events in the later VE group (P = 0.004), but the need for blood transfusions was similar. The rates of 5 min Apgar score ≤7 (P = 0.001) and umbilical artery pH <7.0 were significantly higher in group 2 compared with group 1. The effect was much more pronounced when second stage was >3 h. After conducting multiregression analysis, the results became insignificant. CONCLUSION: Our study suggests that VE performed in the late second stage of labor, up to 3 h, is safe as VE performed in the early stages regarding maternal and neonatal outcomes. Extra caution is needed with extended second stage to more than 3 h.

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PURPOSE: This study evaluated age-related maternal outcomes of vacuum-assisted vaginal deliveries (VAD). METHODS: This retrospective cohort study included all nulliparous women with singleton VAD in one academic institution. Study group parturients were maternal age ≥ 35 years and controls < 35. Power analysis revealed that 225 women/group would be sufficient to detect a difference in the rate of third- and fourth-degree perineal tears (primary maternal outcome) and umbilical cord pH < 7.15 (primary neonatal outcome). Secondary outcomes were maternal blood loss, Apgar scores, cup detachment, and subgaleal hematoma. Outcomes were compared between groups. RESULTS: From 2014 to 2019, 13,967 nulliparas delivered at our institution. Overall, 8810 (63.1%) underwent normal vaginal delivery, 2432 (17.4%) instrumental, and 2725 (19.5%) cesarean. Among 11,242 vaginal deliveries, 10,116 (90%) involved women < 35, including 2067 (20.5%) successful VAD vs. 1126 (10%) women ≥ 35 years with 348 (30.9%) successful VAD (p < 0.001). Rates of third- and fourth-degree perineal lacerations were 6 (1.7%) with advanced maternal age and 57 (2.8%) among controls (p = 0.259). Cord pH < 7.15 was similar: 23 (6.6%) study group and 156 (7.5%) controls (p = 0.739). CONCLUSION: Advanced maternal age and VAD are not associated with higher risk for adverse outcomes. Older, nulliparous women are more likely to undergo vacuum delivery than younger parturients.

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BACKGROUND: The vacuum assisted delivery represents, in France, the most used operative vaginal delivery technique. The purpose was to provide a preliminar quantification of the operator's hand kinematics while performing a vacuum assisted delivery. METHODS: A group of 21 participants composed of 12 trainees and 9 obstetricians were recorded performing a vacuum assisted delivery on a training dummy, the matching fetal presentation was a left occiput anterior position. FINDINGS: The mean movement was composed of a first phase corresponding to a descendant pull, followed by an ascendant finish of the gesture. No significative difference were found between the trainees and the obstetricians' mean gesture. INTERPRETATION: This is the first quantification of the clinical gesture associated with the vacuum assisted delivery.

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Introduction Preterm delivery (gestational age < 34 w) is a relative contraindication to vacuum extraction. Current data do not differentiate clearly between preterm delivery and low birthweight. We aimed to evaluate the impact of non-metal vacuum cup extraction on neonatal head injuries related to birth trauma in newborns with low birthweights (< 2500 g). Materials and Methods A retrospective cohort of 3377 singleton pregnancies delivered by vacuum extraction from 2014 to 2019. All were gestational age ≥ 34 w. We compared 206 (6.1%) neonates with low birthweights < 2500 g to 3171 (93.9%) neonates with higher birthweights, divided into 3 subgroups (2500-2999 g, 3000-3499 g, and ≥ 3500 g). A primary composite outcome of neonatal head injuries related to birth trauma was defined. Results The lowest rates of subgaleal hematoma occurred in neonates < 2500 g (0.5%); the rate increased with every additional 500 g of neonatal birthweight (3.5%, 4.4% and 8.0% in the 2500-2999 g, 3000-3499 g, and ≥ 3500 g groups, respectively; p = 0.001). Fewer cephalohematomas occurred in low birthweight neonates (0.5% in < 2500 g), although the percentage increased with every additional 500 g of birthweight (2.6%, 3.3% and 3.7% in the 2500-2999 g, 3000-3499 g, and ≥ 3500 g groups, respectively, p = 0.020). Logistic regression found increasing birthweight to be a significant risk factor for head injuries during vacuum extraction, with adjusted odds ratios of 8.12, 10.88, and 13.5 for 2500-2999 g, 3000-3499 g, and ≥ 3500 g, respectively (p = 0.016). NICU hospitalization rates were highest for neonates weighing < 2500 g (10.2%) compared to the other groups (3.1%, 1.7% and 3.3% in 2500-2999 g, 3000-3499 g, ≥ 3500 respectively, p < 0.001). Conclusions Vacuum extraction of neonates weighing < 2500 g at 34 w and beyond seems to be a safe mode of delivery when indicated, with lower rates of head injury related to birth trauma, compared to neonates with higher birthweights.

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Although the fetal head position has traditionally been evaluated by digital examination (DE), it has a failure rate ranging between 20 and 70%; hence, intrapartum transabdominal ultrasonography (TUS) has become relevant. We aimed to evaluate the utility of the TUS to identify the fetal head positions in vacuum-assisted deliveries. We performed a prospective observational study including 101 pregnant patients in active labor who required a vacuum-assisted delivery. The fetal head position was assessed by a DE and a TUS prior to vacuum cup placement. After delivery, the optimal vacuum cup placement was evaluated as the distance between the chignon and the flexion point ≤2 cm. The general concordance rate between the DE and TUS was 72.2%, with the poorest concordance rate for occiput posterior positions at 46.1%. In five cases (4.9%), it was not possible to determine the fetal head position through the DE. The correlation was higher in low and medium planes, with 77% and 68.1% concordance rates, respectively, while it was lower in high planes (60%). In 90.1% of cases, the vacuum cup placement was optimal. Our findings show that intrapartum transabdominal ultrasonography is a useful technique to identify the fetal head position allowing optimal placement of the vacuum cup necessary for correct vacuum-assisted delivery.

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OBJECTIVE: To evaluate the association between fetal head position during prevacuum assessment and adverse outcomes. METHOD: This retrospective cohort study included all vacuum-assisted deliveries using the Kiwi Omnicup over 5 years. Primary outcomes were third- or fourth-degree perineal tear, pH < 7.1, and subgaleal hematoma (SGH). AGAR, neonatal intensive care unit admission, cephalohematoma, Erb's palsy, third-stage duration, and postpartum hemorrhage were secondary. Outcomes were compared between the occiput posterior (OP) and occiput anterior (OA) positions. RESULTS: The study included 1960 patients. OP position was more likely to involve epidural analgesia (311 [82.5%] vs. 1216 [77%], P = 0.020), higher fetal head station (P = 0.001), higher percentage of cup detachments (121 cases [32.1%] vs. 307 [19.4%], P = 0.001), and longer procedure (5.5 ± 3.7 min vs. 4.7 ± 2.8 min, P = 0.001). OP was associated with umbilical cord pH < 7.1 (21 [5.5%] vs. 52 [3.9%], P = 0.032), NICU admissions (16 [4.2%] vs. 38 [2.4%], P = 0.049), SGH (18 [4.8%] vs. 38 [2.4%], P = 0.013), and high-degree perineal tears (12 [3.2%] vs. 26 [1.7%], with borderline significance, P = 0.051). SGH and high-grade tears remained significantly associated with OP position (P = 0.008 and P = 0.016, respectively) after adjusting for maternal age, nulliparity, diabetes, epidural anesthesia, preprocedure head station, and birth weight. CONCLUSION: OP position is an independent risk-factor for anal sphincter injury and SGH during vacuum-assisted delivery.

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This retrospective cohort study assessed the association between nuchal cord and adverse outcomes during vacuum-assisted delivery (VAD). Women with singleton pregnancies, 34−41-weeks gestation, who underwent VAD, from 2014 to 2020 were included. The primary outcome was umbilical cord pH ≤ 7.1. Secondary outcomes were neonatal intensive care unit admission, Apgar scores, pH < 7.15, subgaleal hematoma, shoulder dystocia and third/fourth-degree perineal tear. Outcomes were compared between neonates with (1059/3754, 28.2%) or without (71.8%) nuchal cord after VAD. No difference in cord pH ≤ 7.1 was found between groups. The nuchal cord group had a lower rate of nulliparity (729 (68.8%) vs. 2004 (74.4%), p = 0.001) and higher maternal BMI (23.6 ± 4.3 vs. 23.1 ± 5, p = 0.017). Nuchal cord was associated with higher rates of induction (207 (19.5%) vs. 431 (16%), p = 0.009) and lower birthweights (3185 ± 413 vs. 3223 ± 436 g, p = 0.013). The main indication for VAD in 830 (80.7%) of the nuchal cord group was non-reassuring fetal heart rate (NRFHR) vs. 1989 (75.6%) controls (p = 0.004). The second stage was shorter in the nuchal cord group (128 ± 81 vs. 141 ± 80 min, p < 0.001). Multivariate regression found nulliparity, induction and birthweight as independent risk factors for nuchal cord VAD. Although induction and NRFHR rates were higher in VAD with nuchal cord, the rate of umbilical cord acidemia was not.

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Introduction Vacuum extraction (VE) is an important modality in modern obstetrics, yet sometimes results in maternal or neonatal adverse outcomes, which can cause a lifetime disability. We aimed to characterize potential risk factors for adverse outcomes that in retrospect would have led the physician to avoid the procedure. Materials and Methods Retrospective cohort of 3331 singleton pregnancies, ≥ 34 w delivered by VE. 263 deliveries (7.9%) incurred a VE-related feto-maternal adverse outcome, defined as one or more of the following: 3-4th-degree perineal laceration, subgaleal hematoma, intracranial hemorrhage, shoulder dystocia, clavicular fracture, Erb's palsy or fracture of humerus. 3068 deliveries (92.1%) did not have VE-related adverse outcomes. Both groups were compared to determine potential risk factors for VE adverse outcomes. Results Multivariable regression found seven independent risk factors for VE-related feto-maternal adverse outcomes: Nulliparity - with an odds ratio (OR) of 1.82 (95% CI = 1.11-2.98, p = 0.018), epidural anesthesia (OR 1.99, CI = 1.42-2.80, p < 0.001), Ventouse-Mityvac (VM) cup (OR 1.86, CI = 1.35-2.54, p < 0.001), prolonged second stage as indication for VE (OR 1.54, CI = 1.11-2.15, p = 0.010), cup detachment (OR 1.66, CI = 1.18-2.34, p = 0.004), increasing procedure duration (OR 1.07 for every additional minute, CI = 1.03-1.11, p < 0.001) and increasing neonatal birthweight (OR 3.42 for every additional kg, CI = 2.33-5.02, p < 0.001). Occiput anterior (OA) position was a protective factor (OR 0.62, CI = 0.43-0.89, p = 0.010). Conclusions VE-related adverse outcomes can be correlated to clinical characteristics, such as nulliparity, epidural anesthesia, VM cup, prolonged second stage as indication for VE, cup detachment, prolonged procedure duration and increasing neonatal weight. OA position was a protective factor. This information may assist medical staff to make an informed decision whether to choose VE or cesarean delivery (CD).

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The design of obstetrical suction cups used for vacuum assisted delivery has not substantially evolved through history despite of its inherent limitations. The associated challenges concern both the decrease of risk of soft tissue damage and failure of instrumental delivery due to detachment of the cup. The present study firstly details some of the suction-based strategies that have been developed in wildlife in order to create and maintain an adhesive contact with potentially rough and uneven substratum in dry or wet environments. Such strategies have permitted the emergence of bioinspired suction-based devices in the fields of robotics or biomedical patches that are briefly reviewed. The objective is then to extend the observations of such suction-based strategies toward the development of innovative medical suction cups. We firstly conclude that the overall design, shape and materials of the suction cups could be largely improved. We also highlight that the addition of a patterned surface combined with a viscous fluid at the interface between the suction cup and scalp could significantly limit the detachment rate and the differential pressure required to exert a traction force. In the future, the development of a computational model including a detailed description of scalp properties should allow to experiment various designs of bioinspired suction cups.

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INTRODUCTION: During the second stage of labor, vacuum-assisted delivery is an alternative to forceps delivery and emergency cesarean section. Extensive research concerning perinatal outcomes has indicated that the risk of complications, although rare, is higher than with a spontaneous vaginal delivery. An important factor related to perinatal outcomes is the traction force applied. Our research group previously developed a digital extraction handle, the Vacuum Intelligent Handle-3 (VIH3), that measures and records traction force. The objective of this study was to compare traction force profiles in children with and without severe perinatal outcomes delivered with the digital handle. A secondary aim was to establish a safe force limit. MATERIAL AND METHODS: This was an observational case-control study at the delivery ward at Karolinska University Hospital, Sweden. In total, 573 children delivered with the digital handle between 2012 and 2018 were included. Cases were defined as a composite of severe perinatal outcomes, including subgaleal hematoma, intracranial hemorrhage, hypoxic ischemic encephalopathy 1-3, seizures or death. The cases in the cohort were matched 1:3 based on five matching variables. Traction profiles were analyzed using the MATLAB® software and conditional logistic regression. RESULTS: The incidence of severe perinatal outcomes was 2.3%. The 13 cases were matched with three controls each (n = 39). A statistically significant increased odds for higher total traction forces was seen in the case group (odds ratio [OR] 1.004; 95% confidence interval [CI] 1.001-1.007) and for the peak force (OR 1.022; 95% CI 1.004-1.041). Several procedure-related parameters were significantly increased in the case group. As expected, some neonatal characteristics also differed significantly. An upper force limit of 343 Newton minutes (Nmin) revealed an 86% reduction in severe perinatal outcomes (adjusted OR 0.14; 95% CI 0.04-0.5). CONCLUSIONS: Children with severe perinatal outcomes had traction force profiles with significantly higher forces. The odds for severe perinatal outcomes increased for every increase in Nmin and Newton used during the extraction procedure. A calculated total force level of 343 Nmin is suggested as an upper safety limit, but this must be tested prospectively to provide validity.

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This retrospective cohort study investigated the association between ultrasonographic estimated fetal weight (EFW) and adverse maternal and neonatal outcomes after vacuum-assisted delivery (VAD). It included women with singleton pregnancies at 34−41 weeks gestation, who underwent ultrasonographic pre-labor EFW and VAD in an academic institution, over 6 years. Adverse neonatal and maternal outcomes included shoulder dystocia, clavicular fracture, or third- and fourth-degree perineal tears. A receiver−operator characteristic curve was used to identify the optimal weight cut-off value to predict adverse outcomes. Fetuses above and below this point were compared. Multivariate analysis was used to control for factors that could lead to adverse outcomes. Eight-hundred and fifty women met the inclusion criteria and had sonographic EFW within two-weeks before delivery. Receiver−operator characteristic curve analysis found that ultrasonographic EFW 3666 g is the optimal threshold for adverse outcomes. Based on these results, outcomes were compared using EFW 3700 g. The average EFW in the ≥3700 g group (n = 220, 25.9%) was 3898 ± 154 g (average birthweight 3710 ± 324 g). In the group <3700 g (n = 630, 74.1%), average EFW was 3064 ± 411 g (birthweight 3120 ± 464 g). Shoulder dystocia and clavicular fractures were more frequent in the higher EFW group (6.4% and 2.3% vs. 1.6% and 0.5%, respectively; p < 0.05). Women in the ≥3700 g group experienced more third- and fourth-degree perineal tears (3.2% vs. 1%, p = 0.02). Multivariate logistic regression analysis found maternal age, diabetes and sonographic EFW ≥ 3700 g as independent risk-factors for adverse outcomes. Sonographic EFW ≥ 3700 g is an independent risk-factor for adverse outcomes in VAD. This should be considered when choosing the optimal mode of delivery.

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OBJECTIVE: Data regarding the risk factors for obstetrical anal sphincter injury (OASI) among nulliparous advanced maternal age (AMA) women are scarce. We aimed to evaluate the risk factors and the rate of OASI in this population. METHODS: A retrospective case-control study of nulliparous women aged ≥35 who delivered vaginally between March 2011 and August 2021. The study cohort included nulliparous AMA women, aged 35 years or older, delivering vaginally a singleton, vertex neonate. We excluded cases with missing data. Maternal and intrapartum characteristics were compared between OASI and no-OASI groups. We matched groups to the earliest gestational age in which OASI has occurred. RESULTS: A total of 3,635 women met inclusion criteria. Mean age of the participants was 38 years (range 35-56, interquartile range 36-39). The oldest age in which an OASI was diagnosed was 45. A total of 55 (1.5%) cases of OASI were diagnosed. Gestational age at delivery was higher in the OASI group compared to the no-OASI group (mean 396/7±12/7 vs. 391/7±23/7 weeks respectively, p=.039). The rate of induction of labor, oxytocin and epidural analgesia, prolonged second stage, mode of delivery, and rate of blood transfusion did not vary between groups. Estimated fetal weight was higher in the OASI group (3,324 ± 308 vs. 3,114 ± 566 g, p<.001). Sonographic abdominal circumference was higher in the OASI group (338 ± 13 vs. 328 ± 28 mm, p<.001). Mean birthweight was higher in the OASI group (3,286 ± 400 vs. 3,059 ± 541 g, p=.002) and the birthweight centile was higher as well (60 ± 26 vs. 52 ± 25, p=.024).In a multivariable regression analysis including birthweight, gestational age, operative vaginal delivery, epidural anesthesia, and hypertensive disorders-birthweight and hypertensive disorder were positively associated with an OASI odds ratio [OR 95% CI 1.6 (1.1-2.32) for every 500 g increase; 2.42 (1.006-5.82), respectively]. Epidural anesthesia was negatively associated with OASI [OR 95% CI 0.49) 0.27-0.87)]. CONCLUSIONS: Epidural anesthesia is the only modifiable risk factor and is protective against OASI among nulliparous AMA women. Birthweight and hypertensive disorders are also independent predictors of OASI in this population.

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BACKGROUND: Subgaleal hemorrhage (SGH) is a rare neonatal condition, mainly associated with instrumental delivery, mainly vacuum extractor (VE). The aim of this study was to develop a machine learning model that would allow a personalized prediction algorithm for Subgaleal hemorrhage (SGH) following vacuum extraction (VE), based on maternal and fetal variables collected during the first stage of labor. MATERIALS AND METHODS: A retrospective cohort study on data from a university affiliated hospital, recorded between January 2013 and February 2017. Balanced random forest algorithm was used to develop a machine learning model to predict personalized risk of the neonate developing SGH, in the eventuality that vacuum extraction was used during delivery. RESULTS: During the study period, 35,552 term, singleton spontaneous or induced trials of labor deliveries were included in this study. Neonatal SGH following vacuum extraction (SGH-VE) occurred in 109 cases (0.3%). Two machine learning models were developed: a proof of concept model (model A), based on a cohort limited to the (n=2955) instances of vacuum extraction, and the clinical support model (model B), based on all spontaneous or induced trials of labor (n=35,552). The models stratified parturients into high- and low-risk groups for development of SGH-VE. Model A showed a 2-fold increase in the high-risk group of parturients compared to the low risk group (OR=2.76, CI 95% 1.85-4.11). In model B, a 4-fold increase in the odds of SGH was observed in the high-risk group of parturients compared to the low risk group (OR=4.2, CI 2.2-8.1), while identifying 90.8% (99/109) of the SGH cases. CONCLUSIONS: Our machine learning-based model stratified births to high or low risk for SGH, making it an applicable tool for personalized decision-making during labor regarding the application of VE. This model may contribute to improved neonatal outcomes.

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OBJECTIVE: Data regarding the risk factors for obstetrical anal sphincter injury (OASI) among nulliparous adolescent women are scarce. We aimed to evaluate these risk factors. STUDY DESIGN: A retrospective case-control study of nulliparous women aged ≤ 21 who delivered vaginally between 3/2011 and 6/2021. Maternal and intrapartum characteristics were compared between OASI and no-OASI groups. RESULTS: Of 1,342 deliveries, 22 (1.6%) cases of OASI were diagnosed. Maternal anthropometric and demographic characteristics did not vary between study groups. Gestational comorbidity (diabetic and hypertensive disorders) was associated with an increased risk for an OASI [OR 95% CI 3.1 (1.1-8.6)]. The rate of prolonged second stage was associated with an OASI [OR 95% CI 2.5 (1.1-6.5)]. The mode of delivery was similar in both groups. There were no forceps deliveries in the OASI group. Birthweight and the proportion of newborns weighing more than 4,000 g were similar in both study groups. All sonographic biometric measurements did not vary between study groups. Women with an OASI had higher rate of blood transfusion [OR 95% CI 11.4 (3.1-42.0)]. In a multivariable regression analysis, including birthweight, vacuum assisted delivery, prolonged second stage and gestational comorbidity - gestational comorbidity was the only independent factor associated with the occurrence of an OASI [adjusted OR 95% CI 2.9 (1.05-8.17)]. CONCLUSION: Gestational comorbidity is the only predictor of OASI among nulliparous adolescent women.

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OBJECTIVE: To evaluate the association between neonatal weight centile and neonatal and maternal morbidity following vacuum-assisted delivery (VAD) among term nulliparous women. METHODS: A retrospective cohort study of all nulliparous women who delivered at term by VAD between 2011 and 2019. Deliveries were allocated into two groups and compared: (1) delivery of an small-for-gestational-age (SGA) neonate, and (2) delivery of an appropriate-for-gestational-age (AGA) neonate. RESULTS: Overall, 3116 women were included in the study; 2878 (92.4%) were AGA and 163 (5.2%) were SGA and comprised the study groups. Neonatal and maternal adverse outcomes did not vary between groups. Rates of composite neonatal adverse outcome for SGA and AGA neonates were 26 (16.0%) versus 462 (16.1%), respectively (P = 0.972). Duration of the second stage of labor and rate of prolonged second stage were significantly lower among the SGA group compared with the AGA group (P < 0.001 for both comparisons). Maternal rates of anal sphincter injury and postpartum hemorrhage did not differ between groups. CONCLUSION: Neonatal outcomes among SGA neonates delivered by VAD at term did not differ from those of AGA neonates. Maternal outcome did not differ. These data provide reassurance for practitioners to perform VAD in SGA neonates at term.

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OBJECTIVE: To develop a risk score for obstetric anal sphincter injury (OASI) occurrence among nulliparous women delivering vaginally, based on data available at admission for delivery and as labor progresses. METHODS: A retrospective study of all nulliparous women who delivered vaginally between March 2011 and January 2021. Characteristics were compared between OASI and no-OASI groups. Multivariable analyses were performed to identify independent risk factors for OASI occurrence. RESULTS: OASI occurred in 453 (1.7%) of 26 081 women who met the inclusion criteria. The following variables were independently associated with OASI: maternal height (adjusted odds ratio [aOR] 0.97, 95% confidence interval (CI) 0.95-0.99), hypertensive disorders (aOR 1.74, 95% CI 1.03-2.95), sonographic fetal weight estimation (aOR 1.00, 95% CI 1.00-1.00), second-stage duration (aOR 1.00, 95% CI 1.00-1.00), occiput posterior position (aOR 2.87, 95% CI 1.79-4.62), and episiotomy performance (aOR 0.63, 95% CI 0.47-0.84). In a risk score based on variables available at admission for delivery, the presence of two factors was associated with 4.3% OASI risk. Upon incorporating intrapartum variables, the presence of two risk factors was associated with 2.9% OASI rate. CONCLUSION: A dynamic risk score for OASI occurrence based on data available at admission for delivery and as delivery progresses can assist in counseling regarding OASI risk. A dynamic risk score for obstetric anal sphincter injury occurrence based on data available at admission for delivery and intrapartum was developed.

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PURPOSE: Vacuum-assisted deliveries (VAD) are complex procedures that require training and experience to be performed proficiently. We aimed to evaluate if a more resource intensive practice-based training program for conducting VAD is more efficient compared to a purely theory-based training program, with respect to immediate training effects and persistence of skills 4-8 weeks after the initial training. METHODS: In this randomized-controlled study conducted in maternity staff, participants performed a simulated low-cavity non-rotational vacuum delivery before (baseline test) and immediately after the training (first post-training test) as well as 4-8 weeks thereafter (second post-training test). The study's primary endpoint was to compare training effectiveness between the two study groups using a validated objective structured assessment of technical skills (OSATS) rating scale. RESULTS: Sixty-two participants were randomized to either the theory-based group (n = 31) or the practice-based group (n = 31). Total global and specific OSATS scores, as well as distance of cup application to the flexion point improved significantly from baseline test to the first post-training test in both groups (pall < 0.007). Skill deterioration after 4-8 weeks was only found in the theory-based group, whereas skills remained stable in the practice-based group. CONCLUSION: A practice-based training program for conducting VAD results in comparable immediate improvement of skills compared to a theory-based training program, but the retention of skills 4-8 weeks after training is superior in a practice-based program. Future studies need to evaluate, whether VAD simulation training improves maternal and neonatal outcome after VAD.

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PURPOSE: To evaluate neonatal and maternal outcomes associated with detachment of non-metal vacuum cup during delivery and to identify risk factors for these detachments. METHODS: This retrospective cohort study included women with singleton pregnancy, who underwent vacuum-assisted vaginal delivery with a non-metal vacuum cup in a single academic institution, January 2014-August 2019. Failed vacuum deliveries were excluded. Primary outcomes were defined as subgaleal hematoma (SGH) and cord blood pH < 7.15. Secondary outcome included other neonatal complications and adverse maternal outcomes. Outcomes were compared between vacuum-assisted deliveries with and without cup detachment during the procedure. RESULTS: A total of 3246 women had successful VAD and met the inclusion criteria. During the procedure, the cup detached at least once in 665 (20.5%) deliveries and did not detach in 2581 (79.5%). The cup detachment group experienced higher rates of SGH (8.9% vs. 3.5%, p = 0.001) and cord blood pH < 7.15 (9.8% vs. 7.1%, p = 0.03). There were also more neonatal intensive care unit admissions (NICU) (4.4% vs. 2.7%, p = 0.03) and more fetuses with occiput posterior position (70.8% vs. 79.4%, p = 0.001), the vacuum duration was slightly longer (6 ± 3.7 vs. 5 ± 2.9 min) and more neonates had birth weights > 3700 g (14.1% vs, 10.3%, p = 0.006). Interestingly, there were more males in that group (60.6 vs. 54.6, p = 0.005). All these factors remained significant after controlling for potential confounders. CONCLUSIONS: Vacuum cup detachment has several predictive characteristics and is associated with adverse neonatal outcomes that should be incorporated into decisions made during the procedure.

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BACKGROUND: Information about and invitation to participate in a clinical trial involving an intervention during childbirth may cause fear or worry in pregnant women. The aim of this study was to describe nulliparous women's experiences of receiving an invitation to participate in a randomized controlled trial (RCT) of lateral episiotomy versus no episiotomy in vacuum-assisted delivery (EVA trial). METHODS: This qualitative study was nested in the ongoing EVA trial. Data were collected through semistructured telephone interviews with 23 women regarding their experiences of the information and invitation to participate in the EVA trial. Interviews were audio-recorded and transcribed verbatim. A qualitative content analysis was used to analyse the interview contents. RESULTS: Three main experience categories were identified among the participants. "Timing of trial information and understanding" revealed that women preferred to obtain information about the trial early on during pregnancy. "Reasons to consent to or decline participation in the trial" encompassed a variety of reasons for women to consent, such as goodwill for science or personal benefits, or to decline, such as not wanting to be randomized or fear of increased risk of having a vacuum-assisted delivery. "Thoughts evoked regarding childbirth" were diverse, ranging from not being affected at all to having increased anxiety. CONCLUSIONS: The women's experience of receiving an invitation to participate in an RCT of episiotomy in vacuum-assisted delivery varied widely, from immediately giving consent without further worries to increased anxiety or declining participation. Early and personal information with time for reflection was considered most satisfactory. TRIAL REGISTRATION: ClinicalTrials.gov NCT02643108 . Registered on December 28, 2015. The Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women (EVA) trial was registered at www.clinicaltrials.gov .

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