RESUMO
Background: The increased demand for induction of labour (IOL) at 39 weeks' gestation in normal-risk nulliparous patients creates significant logistical challenges for busy maternity units. A potential innovation is commencing induction by means of outpatient cervical ripening, using either a vaginal prostaglandin preparation (Propess) or an osmotic cervical dilator (Dilapan-S). Methods: A Phase III, open label, single centre non-inferiority trial (EudraCT number 2019-004697-25) randomised healthy nulliparous women who chose elective IOL at 39 weeks to one of three methods of initial cervical ripening, specifically 12 h of Dilapan-S(D12), 24 h of Dilapan-S(D24), or 24 h of Propess(P24) between November 2020 and July 2023. After initial administration of the IOL agent in the hospital, participants returned home for 12 or 24 h, before readmission to complete delivery. The primary outcome was vaginal delivery achieved at any time, and this was compared in a non-inferiority analysis of Dilapan-S compared to Propess, within a 10% non-inferiority margin. Secondary outcomes included pairwise comparisons for each induction agent, and a range of logistical factors, such as time to delivery, the need for an additional cervical ripening agent, and length of hospital stay. Findings: Of the 327 women randomised at 38 weeks, 271 (83%) completed the induction intervention. The D24 and P24 groups showed similarly high rates of vaginal delivery, 75% and 76% respectively. D12 had a lower vaginal delivery rate of 64% and consequently the overall comparison of Dilapan-S to Propess did not demonstrate non-inferiority (difference = -6%, 95% CI = -17%, 5%) because the lower 95% CI exceeded the -10% threshold of non-inferiority. The majority of participants across all groups were delivered by any means within 72 h of starting the induction process, inclusive of time spent at home (89% of the D24 group, 98% of the D12 group, 95% of the P24 group). There were no differences in rates of adverse events between groups. Interpretation: There were similarly high vaginal delivery rates for D24 and P24, with at least 75% of patients successfully delivering vaginally following outpatient cervical ripening, with no significant adverse maternal or neonatal outcomes. Funding: The Rotunda Foundation, Medicem Technology s.r.o.
RESUMO
BACKGROUND: Sexual violence is a crime that affects people of all genders. While focus is frequently on female survivors, it is crucial to acknowledge that males also experience sexual violence and to ensure that gender-sensitive services are available to all survivors. Understanding the prevalence of, and factors associated with, sexual violence against males is a critical first step in addressing this issue. We aim to address the lack of data in relation to sexual violence against males. METHODS: A cross-sectional study of all male attendances at 6 Sexual Assault Treatment Units (SATU) in the Republic of Ireland over a 6-year period and, where applicable, comparison with corresponding female attendances. RESULTS: There were 381 male attendances with an average age of 28.5 years over the study period, representing 7 % of all SATU patients. There was a 24 % increase in male attendances during the study period. 39.1 % presented within 24 h of the assault. 61.9 % reported the crime to the police. Employment status included 37.3 % employed, 24.9 % unemployed, and 26.2 % students, with 86.7 % being Irish nationals. Most incidents occurred on weekdays (53.3 %) and at night (56.7 %). Referrals were primarily from police (55.9 %), and psychological support was provided in 62.3 % of cases. Alcohol (60.4 %) and illicit drugs (20.5 %) were reported before assaults. 18.6 % suspected drug-facilitated assaults. Male assailants constituted 90.1 %, with 13.9 % involving multiple assailants. Male attenders were significantly more likely than females to be assaulted in their assailant's home and to be assaulted by more than one assailant. They were significantly less likely than females to report the crime to the police or to have consumed alcohol. CONCLUSION: To our knowledge, this is one of the largest case series of male patients attending a sexual assault treatment service to be published in the international literature. Male patients are a distinct group that are increasingly accessing SATU services. Significant differences exist between male and female patients' reported experiences of sexual violence. Knowledge of these factors will support appropriate tailoring of treatment & service provision, prevention and awareness strategies to help modify the impact and reduce the incidence of sexual violence in this cohort.