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AbstractObjectiveTo assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction.DesignA multicentre, open label, randomised controlled trial.SettingEight hospitals in Sweden, 2017-23.Participants717 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.InterventionA 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.Main outcome measuresThe 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).ResultsFrom 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.ConclusionsLateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury.Trial registrationClinicalTrials.gov NCT02643108.

Background The World Health Organization does not recommend dilatation and sharp curettage (D&C) for the surgical treatment of miscarriage during the first trimester because this may cause Asherman’s syndrome due to endometrial damage; therefore, suction remains the primary treatment option. While manual vacuum aspiration (MVA) has been widely used since the 1990s outside Japan, the use of an MVA device (Women’s MVA system) was approved in Japan in October 2015. Here, we examined the efficacy of the MVA kit in women surgically treated for miscarriage. Methods This retrospective cohort study was conducted between 2014 and 2018 at the International University of Health and Welfare Hospital in Japan. Women who underwent surgical treatment for miscarriage within 12 weeks of pregnancy were identified and enrolled in the study. A total of 404 women were included who underwent the following procedures: 121 D&C, 123 electric vacuum aspiration (EVA), and 160 MVA. For each participant, the duration of surgery, amount of bleeding, amount of anesthetic used, incomplete abortion requiring repeat procedures, and intraoperative/postoperative complications were evaluated. Results The duration of surgery was 13.7 ± 7.2, 11.2 ± 4.2, and 6.9 ± 4.3 min in the D&C, EVA, and MVA groups, respectively ( p  = 1.00). The amount of anesthetic used was not significantly different among all groups. Bleeding of ≥ 100 mL was confirmed in three (2.4%), one (0.8%), and one (0.6%) patient(s) in the D&C, EVA, and MVA groups, respectively ( p  = 0.50). Incomplete abortion was identified in three (2.4%), two (1.6%), and one (0.6%) patient(s) in the D&C, EVA, and MVA groups, respectively ( p  = 0.61). However, severe intraoperative/postoperative complications were not observed in any group. Conclusions Surgical treatment for miscarriage performed using the MVA kit has safety and efficacy similar to those of conventional methods, such as D&C and EVA.

Introduction and hypothesisVaginal delivery may lead to levator ani muscle (LAM) injury or avulsion. Episiotomy may reduce obstetric anal sphincter injury in operative vaginal delivery, but may increase the risk of LAM injury. Our aim was to assess whether lateral episiotomy in vacuum extraction (VE) in primiparous women causes LAM injury.MethodsA prospective cohort study of 58 primiparous women with episiotomy nested within an ongoing multicenter randomized controlled trial of lateral episiotomy versus no episiotomy in VE (EVA trial) was carried out in Sweden. LAM injury was evaluated using 3D endovaginal ultrasound 6–12 months after delivery and Levator Ani Deficiency (LAD) score. Episiotomy scar properties were measured. Characteristics were described and compared using Chi-squared tests. We stipulated that if a lateral episiotomy cuts the LAM, ≥50% would have a LAM injury. Among those, ≥50% would be side specific. We compared the observed prevalence with a test of one proportion.ResultsTwelve (20.7%, 95% CI 10.9–32.9) of 58 women had a LAD (p < 0.001, compared with the stipulated 50%). Six (50.0%, 95% CI 21.1% to 78.9%) of 12 women had a LAD on the episiotomy side, including those with bilateral LAD (p = 1.00). Two (16.7%, 95% CI 2.1% to 48.4%) of 12 women had a LAD exclusively on the episiotomy side (p = 0.02).ConclusionsThere was no excessive risk of cutting the LAM while performing a lateral episiotomy. LAD was not seen in women with episiotomies shorter than 18 mm.

Background Low and mid station vacuum assisted deliveries (VAD) are delicate manual procedures that entail a high degree of subjectivity from the operator and are associated with adverse neonatal outcome. Little has been done to improve the procedure, including the technical development, traction force and the possibility of objective documentation. We aimed to explore if a digital handle with instant haptic feedback on traction force would reduce the neonatal risk during low or mid station VAD. Methods A two centre, randomised superiority trial at Karolinska University Hospital, Sweden, 2016–2018. Cases were randomised bedside to either a conventional or a digital handle attached to a Bird metal cup (50 mm, 80 kPa). The digital handle measured applied force including an instant notification by vibration when high levels of traction force were predicted according to a predefined algorithm. Primary outcome was a composite of hypoxic ischaemic encephalopathy, intracranial haemorrhage, seizures, death and/or subgaleal hematoma. Three hundred eighty low and mid VAD in each group were estimated to decrease primary outcome from six to 2 %. Results After 2 years, an interim analyse was undertaken. Meeting the inclusion criteria, 567 vacuum extractions were randomized to the use of a digital handle ( n  = 296) or a conventional handle ( n  = 271). Primary outcome did not differ between the two groups: (2.7% digital handle vs 2.6% conventional handle). The incidence of primary outcome differed significantly between the two delivery wards (4% vs 0.9%, p  < 0.05). A recalculation of power revealed that 800 cases would be needed in each group to show a decrease in primary outcome from three to 1 %. This was not feasible, and the study therefore closed. Conclusions The incidence of primary outcome was lower than estimated and the study was underpowered. However, the difference between the two delivery wards might reflect varying degree of experience of the technical equipment. An objective documentation of the extraction procedure is an attractive alternative in respect to safety and clinical training. To demonstrate improved safety, a multicentre study is required to reach an adequate cohort. This was beyond the scope of the study. Trial registration ClinicalTrials.gov NCT03071783 , March 1, 2017, retrospectively registered.

Background Vaginal delivery, especially operative assisted vaginal delivery, seems to be a major stressor for the neonate. The objective of this study was to evaluate the stress response after metal cup versus Kiwi Omnicup® ventouse delivery. Methods The study was a secondary observational analysis of data from a former prospective randomised placebo controlled multicentre study on the analgesic effect of acetaminophen in neonates after operative vaginal delivery and took place at three Swiss tertiary hospitals. Healthy pregnant women ≥35 weeks of gestation with an estimated fetal birth weight above 2000 g were recruited after admission to the labour ward. Pain reaction was analysed by pain expression score EDIN scale (Échelle Douleur Inconfort Nouveau-Né, neonatal pain and discomfort scale) directly after delivery. For measurement of the biochemical stress response, salivary cortisol as well as the Bernese Pain Scale of Newborns (BPSN) were evaluated before and after an acute pain stimulus (the standard heel prick for metabolic testing (Guthrie test)) at 48–72 h. Results Infants born by vaginal operative delivery displayed a lower pain response after plastic cup than metal cup ventouse delivery ( p <  0.001), but the pain response was generally lower than expected and they recovered fully within 72 h. Conclusions Neonatal pain response is slightly reduced after use of Kiwi OmniCup® versus metal cup ventouse. Trial registration Trial was registered under under NCT00488540 on 19th June 2007.

Background Assisted vaginal delivery by vacuum extraction is frequent. Metallic resterilizible metallic vacuum cups have been routinely used in France. In the last few years a new disposable semi-soft vacuum extraction cup, the iCup, has been introduced. Our objective was to compare maternal and new-born outcomes between this disposable cup and the commonly used Drapier-Faure metallic cup. Methods This was a multicenter prospective randomized controlled open clinical trial performed in the maternity units of five university hospitals and one community hospital in France from October 2009 to February 2013. We included consecutive eligible women with a singleton gestation of at least 37 weeks who required vacuum assisted delivery. Women were randomized to v acuum extraction using the iCup or usual Drapier-Faure metallic cup. The primary outcome was a composite criterion including both the risk of cup dysfunction and the most frequent maternal and neonatal harms: the use of other instruments after attempted vacuum extraction, caesarean section after attempted vacuum extraction, three detachments of the cup, caput succedaneum, cephalohaematoma, episiotomy and perineal tears. Results 335 women were randomized to the disposable cup and 333 to extraction using the metallic cup. There was no significant difference between the two groups for the primary outcome. However, failed instrumental delivery was more frequent in the disposable cup group, mainly due to detachment: 35.6 % vs 7.1 %, p <  0.0001. Conversely, perineal tears were more frequent in the metallic cup group, especially third or fourth grade perineal tears: 1.7 % versus 5.0 %, p =  0.003. There were no significant differences between the two groups concerning post-partum haemorrhage, transfer to a neonatal intensive care unit (NICU) or serious adverse events. Conclusions While the disposable cup had more detachments and extraction failures than the standard metallic cup, this innovative disposable device had the advantage of fewer perineal injuries. Trial registration www.clinicaltrials.gov : NCT01058200 on Jan. 27 2010.

Giulia Muraca and colleagues argue that Canada’s high rates of maternal and neonatal trauma following operative vaginal delivery warrant urgent recognition, transparency, and action

Operative vaginal delivery (OVD) is considered safe if carried out by trained personnel. However, opportunities for training in OVD have declined and, given these shifts in practice, the safety of OVD is unknown. We estimated incidence rates of trauma following OVD in Canada, and quantified variation in trauma rates by instrument, region, level of obstetric care and institutional OVD volume. We conducted a cohort study of all singleton, term deliveries in Canada between April 2013 and March 2019, excluding Quebec. Our main outcome measures were maternal trauma (e.g., obstetric anal sphincter injury, high vaginal lacerations) and neonatal trauma (e.g., subgaleal hemorrhage, brachial plexus injury). We calculated adjusted and stabilized rates of trauma using mixed-effects logistic regression. Of 1 326 191 deliveries, 38 500 (2.9%) were attempted forceps deliveries and 110 987 (8.4%) were attempted vacuum deliveries. The maternal trauma rate following forceps delivery was 25.3% (95% confidence interval [CI] 24.8%–25.7%) and the neonatal trauma rate was 9.6 (95% CI 8.6–10.6) per 1000 live births. Maternal and neonatal trauma rates following vacuum delivery were 13.2% (95% CI 13.0%–13.4%) and 9.6 (95% CI 9.0–10.2) per 1000 live births, respectively. Maternal trauma rates remained higher with forceps than with vacuum after adjustment for confounders (adjusted rate ratio 1.70, 95% CI 1.65–1.75) and varied by region, but not by level of obstetric care. In Canada, rates of trauma following OVD are higher than previously reported, irrespective of region, level of obstetric care and volume of OVD among hospitals. These results support a reassessment of OVD safety in Canada.

PurposeNulliparity and operative vaginal delivery are established risk factor for obstetric anal sphincter injury (OASI). However, risk factors for OASIS occurrence among parous women delivering vaginally are not well-established. We aimed to study the risk factors for OASI occurrence among parous women.MethodsA retrospective study including all parous women who delivered vaginally at term during 2011–2019 at a university hospital. Deliveries of parous women with OASI were compared to deliveries without OASI. The risk factors associated with OASI were investigated.ResultsOverall, 35,397 women were included in the study with an OASI rate of 0.4% (n = 144). A higher rate of only one previous vaginal delivery was noted in the OASI group (78.5% vs. 46.4%, OR [95% CI] 4.20, 2.82–6.25, p < 0.001). The rate of vacuum-assisted deliveries was comparable between the study groups. The median birth weight was higher among the OASI group (3566 vs. 3300 g, p < 0.001), as was the rate of macrosomic neonates (19.4% vs. 5.5%, OR [95% CI] 4.15, 2.74–6.29, p < 0.001). On multivariate logistic regression analysis, only two factors were independently positively associated with the occurrence of OASI: a history of only one previous vaginal delivery (adjusted OR [95% CI] 4.34, 2.90–6.49, p = 0.001), and neonatal birth-weight (for each 500 g increment) (adjusted OR [95% CI] 2.51, 1.84–3.44, p < 0.001).ConclusionsAmong parous women, the only factors found to be independently positively associated with OASI were the order of parity and neonatal birth-weight. Vacuum-assisted delivery was not associated with an increased risk of OASI among parous women.

Background Many women are not prepared for changes to their sexual health after childbirth. The aim of this paper is to report on the prevalence of and the potential risk factors (pre-pregnancy dyspareunia, mode of birth, perineal trauma and breastfeeding) for sexual health issues (dyspareunia, lack of vaginal lubrication and a loss of interest in sexual activity) at 6 and 12 months postpartum. Methods A longitudinal cohort study of 832 first-time mothers who were recruited in early pregnancy and returned postnatal surveys at 3, 6, 9 and 12 months postpartum were assessed for sexual health issues and associated risk factors. Results Nearly half of the women (46.3%) reported a lack of interest in sexual activity, 43% experienced a lack of vaginal lubrication and 37.5% of included women had dyspareunia 6 months after birth. On univariate analysis, vacuum-assisted birth, 2nd degree perineal tears, 3rd degree perineal tears and episiotomy were all associated with dyspareunia 6 months postpartum, but, of these only 3rd degree tears, in association with breastfeeding and pre-existing dyspareunia, remained significant on multivariable analysis. Breastfeeding, in combination, with other significant factors, was associated with dyspareunia, a lack of vaginal lubrication and a loss of interest in sexual activity 6 months postpartum, and, dissatisfaction with body image emerged as a significant factor associated with lack of interest in sexual activity at 12 months postpartum. Pre-pregnancy dyspareunia and breastfeeding emerged as common factors associated with all three outcomes of dyspareunia, a lack of vaginal lubrication and a loss of interest in sexual activity at 6 months postpartum. Conclusion Breastfeeding and pre-existing dyspareunia are associated with sexual health issues at 6 months postpartum. Pre-existing dyspareunia is associated with a lack of vaginal lubrication at 12 months postpartum and breastfeeding is associated with dissatisfaction with body image. Preparing women and their partners during the antenatal period and advising on simple measures, such as use of lubrication to avoid or minimise sexual health issues, could potentially remove stress, anxiety and fears regarding intimacy after birth. Introducing the topic of pre-existing sexual health issues antenatally may facilitate appropriate support, treatment or counselling for women.