Outpatient elective induction of labour at 39 weeks' gestation (HOME INDUCTION): an open-label, randomised, controlled, phase III, non-inferiority trial.

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.

Do obstetrics trainees working hours affect caesarean section rates in normal risk women?

OBJECTIVES: The rate of caesarean section (CS) is increasing globally. The nulliparous, term, singleton, vertex presentation, spontaneously labouring woman (Robson Group 1/RG1) is considered low risk for CS. It has been hypothesized that more CS occur at nighttime or at weekends due to doctor fatigue. The European Working Time Directive (EWTD) was implemented in our institution in 2013 to limit doctor working hours, which aimed at reducing fatigue but arguably fractures continuity of care. This study aimed to determine the effect of nocturnal hours and weekend on-call as well as the implementation of EWTD on our RG1 CS rates. STUDY DESIGN: This was a population-based study in a tertiary referral centre from 2008-2017. The inclusion criteria for our study were limited to RG1. Data were analysed from an established clinical database, including mode and time of delivery. Descriptive statistics are presented as number and percent for categorical variables. Relative frequencies were tested using chi-squared test. All statistical analyses were performed using SPSS Version 26. Statistical significance was defined as p < .05. RESULTS: There were 86,473 deliveries over the 10-year study period. There were 18,761 women in RG1. Overall the RG1 CS rate was 12.9 % (n = 2415). Rates of CS in the RG1 were not statistically different between those delivering on weekdays (12.9 %, n = 1726/13,430) and weekends (12.9 %, n = 689/5,331, OR 0.99, 95 % CI = 0.90-1.09, p = .89). During daytime hours the CS rate was 12.1 % (n = 777/6411) and at nighttime was 13.3 % (n = 1638/12,350, OR 1.10, 95 % CI = 1.01-1.21, p = .03). Comparing the time periods pre and post EWTD implementation, there was a significant increase in CS rates (12.1 % n = 1319/10,873 V 13.9 % n = 1096/7,888, OR 1.17, 95 % CI = 1.07-1.27 p < .001). With respect to other modes of delivery in RG1 pre and post EWTD, there was a statistically significant decrease in operative vaginal delivery (OVD) rates (40.1%, n=4,360 V 37.7%, n=2,973, OR 0.90, 95% CI = 0.85-0.95, p = .001) CONCLUSION: This study shows an association between obstetric trainee working practices, RG1 CS and OVD rates; this is most pronounced at night and after the introduction of the EWTD. It is unlikely that obstetric trainee working practices are the only factor related to the increasing CS rate and reduced OVD rate. Consideration should be giving to addressing the needs of obstetric trainees in relation to achieving their competencies with now reduced labour ward exposure. Further study is required to see if alternate arrangements in relation to simulation training could increase the OVD rate and reduce the CS rate.

Infants Born with Down Syndrome: Burden of Disease in the Early Neonatal Period.

OBJECTIVE: To evaluate the incidence of direct admission of infants with Down syndrome to the postnatal ward (well newborn nursery) vs the neonatal intensive care unit (NICU), and to describe the incidence of congenital heart disease (CHD) and pulmonary hypertension (PH). STUDY DESIGN: This retrospective cohort study of Down syndrome used the maternal/infant database (2011-2016) at the Rotunda Hospital in Dublin, Ireland. Admission location, early neonatal morbidities, outcomes, and duration of stay were evaluated and regression analyses were conducted to identify risk factors associated with morbidity and mortality. RESULTS: Of the 121 infants with Down syndrome, 54 (45%) were initially admitted to the postnatal ward, but 38 (70%) were later admitted to the NICU. Low oxygen saturation profile was the most common cause for the initial and subsequent admission to the NICU. Sixty-six percent of the infants (80/121) had CHD, 34% (41/121) had PH, and 6% died. Risk factors independently associated with primary NICU admission included antenatal diagnosis of Down syndrome, presence of CHD, PH, and the need for ventilation. CONCLUSIONS: Infants with Down syndrome initially admitted to the postnatal ward have a high likelihood of requiring NICU admission. Overall, high rates of neonatal morbidity were noted, including rates of PH that were higher than previously reported. Proper screening of all infants with Down syndrome for CHD and PH is recommended to facilitate timely diagnoses and potentially shorten the duration of the hospital stay.