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To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction.
A multicentre, open label, randomised controlled trial.
Eight hospitals in Sweden, 2017-23.
717 nulliparous women with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction were randomly assigned (1:1) to lateral episiotomy or no episiotomy using sealed opaque envelopes. Randomisation was stratified by study site.
A standardised lateral episiotomy was performed during the vacuum extraction, at crowning of the fetal head, starting 1-3 cm from the posterior fourchette, at a 60° (45-80°) angle from the midline, and 4 cm (3-5 cm) long. The comparison was no episiotomy unless considered indispensable.
The primary outcome of the episiotomy in vacuum assisted delivery (EVA) trial was obstetric anal sphincter injury, clinically diagnosed by combined visual inspection and digital rectal and vaginal examination. The primary analysis used a modified intention-to-treat population that included all consenting women with attempted or successful vacuum extraction. As a result of an interim analysis at significance level P<0.01, the primary endpoint was tested at 4% significance level with accompanying 96% confidence interval (CI).
From 1 July 2017 to 15 February 2023, 717 women were randomly assigned: 354 (49%) to lateral episiotomy and 363 (51%) to no episiotomy. Before vacuum extraction attempt, one woman withdrew consent and 14 had a spontaneous birth, leaving 702 for the primary analysis. In the intervention group, 21 (6%) of 344 women sustained obstetric anal sphincter injury, compared with 47 (13%) of 358 women in the comparison group (P=0.002). The risk difference was -7.0% (96% CI -11.7% to -2.5%). The risk ratio adjusted for site was 0.47 (96% CI 0.23 to 0.97) and unadjusted risk ratio was 0.46 (0.28 to 0.78). No significant differences were noted between groups in postpartum pain, blood loss, neonatal outcomes, or total adverse events, but the intervention group had more wound infections and dehiscence.
Lateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury.
ClinicalTrials.gov NCT02643108.

To investigate neonatal injuries, morbidities and risk factors related to vaginal deliveries. This retrospective, descriptive study identified 3500 patients who underwent vaginal delivery between 2020 and 2022. Demographic data, neonatal injuries, complications arising from vaginal delivery and pertinent risk factors were documented. Neonatal injuries and morbidities were prevalent in cases of assisted vacuum delivery, gestational diabetes mellitus class A2 (GDMA2) and pre-eclampsia with severe features. Caput succedaneum and petechiae were observed in 291/3500 cases (8.31%) and 108/3500 cases (3.09%), respectively. Caput succedaneum was associated with multiparity (adjusted odds ratio [AOR] 0.36, 95% confidence interval [CI] 0.22-0.57, P < 0.001) and assisted vacuum delivery (AOR 5.18, 95% CI 2.60-10.3, P < 0.001). Cephalohaematoma was linked to GDMA2 (AOR 11.3, 95% CI 2.96-43.2, P < 0.001) and assisted vacuum delivery (AOR 16.5, 95% CI 6.71-40.5, P < 0.001). Scalp lacerations correlated with assisted vacuum and forceps deliveries (AOR 6.94, 95% CI 1.85-26.1, P < 0.004; and AOR 10.5, 95% CI 1.08-102.2, P < 0.042, respectively). Neonatal morbidities were associated with preterm delivery (AOR 3.49, 95% CI 1.39-8.72, P = 0.008), night-time delivery (AOR 1.32, 95% CI 1.07-1.63, P = 0.009) and low birth weight (AOR 7.52, 95% CI 3.79-14.9, P < 0.001). Neonatal injuries and morbidities were common in assisted vacuum delivery, maternal GDMA2, pre-eclampsia with severe features, preterm delivery and low birth weight. Cephalohaematoma and scalp lacerations were prevalent in assisted vaginal deliveries. Most morbidities occurred at night.Clinical trial registration: Thai Clinical Trials Registry 20220126004.

OBJECTIVE: Obstetric anal sphincter injury (OASI) is a major complication associated with vacuum-assisted vaginal delivery (VAVD). The aim of this study was to evaluate risk factors related to vacuum extraction that are associated with OASI.
METHODS: This was a case-control study performed at a tertiary university teaching hospital. Included were patients aged 18-45 years who had a singleton pregnancy resulting in a live, term, VAVD. The study group consisted of women diagnosed with OASI following vacuum extraction. The control group included women following VAVD without OASI. Matching at a ratio of 1:2 was performed. Groups were compared regarding demographic, obstetric. and labor-related parameters, specifically focusing on variables related to the vacuum procedure itself.
RESULTS: One hundred and ten patients within the study group and 212 within the control group were included in the final analysis. Patients in the OASI group were more likely to undergo induction of labor, use of oxytocin during labor, increased second stage of labor, higher likelihood of the operator being a resident, increased number of pulls, procedure lasting under 10 min, occipito-posterior head position at vacuum initiation, episiotomy, increased neonatal head circumference, and birthweight. Multivariate logistic regression analysis revealed that increased week of gestation (OR 1.67, 95% CI 1.25-2.22, p < 0.001), unsupervised resident performing the procedure (OR 4.63, 95% CI 2.17-9.90), p < 0.001), indication of VAVD being fetal distress (OR 2.72, 95% CI 1.04-7.10, p = 0.041), and length of procedure under 10 min (OR 4.75, 95% CI 1.53-14.68, p = 0.007) were associated with OASI. Increased maternal age was associated with lower risk of OASI (OR 0.9, 95% CI 0.84-0.98, p = 0.012).
CONCLUSIONS: When performing VAVD, increased week of gestation, unsupervised resident performing the procedure, fetal distress as vacuum indication, and vacuum procedure under 10 min were associated with OASI. In contrast, increased maternal age was shown to be a protective factor.

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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.
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.
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.
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).
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.

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

OBJECTIVE: To investigate the effect of vacuum extraction (VE) or caesarean section (CS), compared with expectant management, on pelvic floor dysfunction (PFD) 1-2 years postpartum in primiparous women with a prolonged second stage of labour.
METHODS: A population-based questionnaire and cohort study.
METHODS: Stockholm, Sweden.
METHODS: A cohort of 1302 primiparous women with a second stage duration of ≥3 h, delivering from December 2017 to November 2018.
METHODS: The 1-year follow-up questionnaire from the Swedish National Perineal Laceration Register was distributed 12-24 months postpartum. Exposure was VE or CS at 3-4 h or 4-5 h, compared with expectant management.
METHODS: Pelvic floor dysfunction was defined as at least weekly symptoms of urinary incontinence, pelvic organ prolapse or a Wexner score of ≥4. The risk of PFD was calculated using Poisson regression with robust variance estimation, presented as crude and adjusted relative risks (RRs and aRRs) with 95% confidence intervals (95% CIs). The implication of obstetric anal sphincter injury (OASI) on pelvic floor disorders was investigated through mediation analysis.
RESULTS: In total, 35.1% of women reported PFD. Compared with expectant management, the risk of PFD was increased after VE at 3-4 h (aRR 1.33, 95% CI 1.06-1.65) and 4-5 h (aRR 1.34, 95% CI 1.05-1.70), but remained unchanged after CS. The increased risk after VE was not mediated by OASI.
CONCLUSIONS: Pelvic floor dysfunction was common in primiparous women after a prolonged second stage, and the risk of PFD increased after VE but was unaffected by CS, compared with expectant management. If a spontaneous vaginal delivery eventually occurred, allowing an extended duration of labour did not increase the risk of PFD.

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