Factors influencing the likelihood of instrumental delivery success.

OBJECTIVE: To evaluate risk factors for unsuccessful instrumental delivery when variability between individual obstetricians is taken into account. METHODS: We conducted a retrospective cohort study of attempted instrumental deliveries over a 5-year period (2008-2012 inclusive) in a tertiary United Kingdom center. To account for interobstetrician variability, we matched unsuccessful deliveries (case group) with successful deliveries (control group) by the same operators. Multivariate logistic regression was used to compare successful and unsuccessful instrumental deliveries. RESULTS: Three thousand seven hundred ninety-eight instrumental deliveries of vertex-presenting, single, term newborns were attempted, of which 246 were unsuccessful (6.5%). Increased birth weight (odds ratio [OR] 1.11; P<.001), second-stage labor duration (OR 1.01; P<.001), rotational delivery (OR 1.52; P<.05), and use of ventouse compared with forceps (OR 1.33; P<.05) were associated with unsuccessful outcome. When interobstetrician variability was controlled for, instrument selection and decision to rotate were no longer associated with instrumental delivery success. More senior obstetricians had higher rates of unsuccessful deliveries (12% compared with 5%; P<.05) but were used to undertake more complicated cases. Cesarean delivery during the second stage of labor without previous attempt at instrumental delivery was associated with higher birth weight (OR 1.07; P<.001), increased maternal age (OR 1.03; P<.01), and epidural analgesia (OR 1.46; P<.001). CONCLUSION: Results suggest that birth weight and head position are the most important factors in successful instrumental delivery, whereas the influence of instrument selection and rotational delivery appear to be operator-dependent. Risk factors for lack of instrumental delivery success are distinct from risk factors for requiring instrumental delivery, and these should not be conflated in clinical practice.This is the author accepted manuscript. The final version is published in Obstetrics & Gynecology 123: 796-803. doi: 10.1097/AOG.0000000000000188, which can be found here: http://journals.lww.com/greenjournal/Abstract/2014/04000/Factors_Influencing_the_Likelihood_of_Instrumental.11.asp

The influence of hours worked prior to delivery on maternal and neonatal outcomes: a retrospective cohort study.

BACKGROUND: Long continuous periods of working contribute to fatigue, which is an established risk factor for adverse patient outcomes in many clinical specialties. The total number of hours worked by delivering clinicians before delivery therefore may be an important predictor of adverse maternal and neonatal outcomes. OBJECTIVE: We aimed to examine how rates of adverse delivery outcomes vary with the number of hours worked by the delivering clinician before delivery during both day and night shifts. STUDY DESIGN: We conducted a retrospective cohort study of 24,506 unscheduled deliveries at an obstetrics center in the United Kingdom from 2008-2013. We compared adverse outcomes between day shifts and night shifts using random-effects logistic regression to account for interoperator variability. Adverse outcomes were estimated blood loss of ≥1.5 L, arterial cord pH of ≤7.1, failed instrumental delivery, delayed neonatal respiration, severe perineal trauma, and any critical incident. Additive dynamic regression was used to examine the association between hours worked before delivery (up to 12 hours) and risk of adverse outcomes. Models were controlled for maternal age, maternal body mass index, parity, birthweight, gestation, obstetrician experience, and delivery type. RESULTS: We found no difference in the risk of any adverse outcome that was studied between day vs night shifts. Yet, risk of estimated blood loss of ≥1.5 L and arterial cord pH of ≤7.1 both varied by 30-40% within 12-hour shifts (P<.05). The highest risk of adverse outcomes occurred after 9-10 hours from the beginning of the shift for both day and night shifts. The risk of other adverse outcomes did not vary significantly by hours worked or by day vs night shift. CONCLUSION: Number of hours already worked before undertaking unscheduled deliveries significantly influences the risk of certain adverse outcomes. Our findings suggest that fatigue may play a role in increasing the risk of adverse delivery outcomes later in shifts and that obstetric work patterns could be better designed to minimize the risk of adverse delivery outcomes.ARA is supported by grant P2CHD047879, awarded to the Office of Population Research at Princeton University by The Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. JGS is supported by a CAREER grant from the U.S. National Science Foundation (DMS-1255187).This is the author accepted manuscript. The final version is available from Elsevier via http://dx.doi.org/10.1016/j.ajog.2016.06.02

Factors associated with adverse clinical outcomes among obstetrics trainees.

OBJECTIVES: This study was conducted to determine whether UK obstetrics trainees transitioning from directly to indirectly supervised practice have a higher likelihood of recording adverse patient outcomes in operative deliveries compared with other indirectly supervised trainees, and to examine whether performing more procedures under direct supervision is associated with fewer adverse outcomes in initial practice under indirect supervision. METHODS: We examined all deliveries (13 856) conducted by obstetricians at a single centre over 6 years (2008-2013). Mixed-effects logistic regression models were used to compare estimated blood loss (EBL), maternal trauma, umbilical arterial pH, delayed neonatal respiration, failed instrumental delivery, and critical incidents for trainees in their first indirectly supervised year with those for trainees in all other years of indirect supervision. Outcomes for trainees in their first indirectly supervised 3 months were compared with their outcomes for the remainder of the year. Linear regression was used to examine the relationship between number of procedures performed under direct supervision and initial outcomes under indirect supervision. RESULTS: Trainees in their first indirectly supervised year had a higher likelihood of recording EBL of > 2 L at any delivery (odds ratio [OR] 1.32, 95% confidence interval [CI] 1.01-1.64; p  1 L (OR 2.54, 95% CI 1.88-3.20; p  1 L (p < 0.05). CONCLUSIONS: Obstetrics trainees in their first year of indirectly supervised practice have a higher likelihood of recording immediate adverse delivery outcomes, which are primarily maternal rather than neonatal. Undertaking more directly supervised procedures prior to transitioning to indirectly supervised practice may reduce adverse outcomes, which suggests that experience is a key consideration in obstetrics training programme design.ARA is supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) grant for Infrastructure for Population Research at Princeton University (Grant R24HD047879). During the initial preparation of this manuscript she was also supported by an NICHD Individual Predoctoral Fellowship (Grant F31HD079182) and an NICHD infrastructure grant awarded to the Population Research Center at The University of Texas at Austin (Grant R24HD042849).This is the author accepted manuscript. The final version is available from Wiley via http://dx.doi.org/10.1111/medu.12741

Weekend working: a retrospective cohort study of maternal and neonatal outcomes in a large NHS delivery unit.

OBJECTIVES: Mandatory weekend working for NHS consultants is currently the subject of intense political debate. The Secretary of State for Health's proposed 7-day contract policy is based on the claim that such working patterns will improve patient outcomes. We evaluate this claim by taking advantage of as-if-at-random presentation of women for non-elective deliveries throughout the week. We examine (i) whether consultants currently perform fewer deliveries during weekends versus weekdays, and (ii) whether adverse outcomes increase during weekends. STUDY DESIGN: We conducted a retrospective cohort study using data on all non-elective deliveries from January 2008 to December 2013 in a large UK obstetrics centre (n=27,466). We used Pearson's chi-squared tests to make direct comparisons of adverse outcome rates during weekdays versus weekends. Outcomes included: estimated maternal blood loss ≥1.5l; severe perineal trauma; delayed neonatal respiration; umbilical arterial pH <7.1; and critical incidents at delivery. RESULTS: Consultants currently perform the same proportion of non-elective deliveries on weekends and weekdays (2.3% versus 2.6%, p=0.25). We found no increase in any adverse maternal or neonatal outcomes during weekends versus weekdays, despite high statistical power to detect such differences. Moreover, adverse outcomes are no higher during periods of the weekend when consultants are not routinely present compared to equivalent periods during weekdays. CONCLUSIONS: Under current working arrangements, women who would benefit from consultant-led delivery are equally likely to receive one on weekends compared to weekdays. Weekend delivery has no effect on maternal or neonatal morbidity. Adopting mandatory 7-day contracts is unlikely to make any difference to either consultant-led delivery during weekends or to patient outcomes.The Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (Grant ID: P2CHD047879)This is the author accepted manuscript. The final version is available from Elsevier via http://dx.doi.org/10.1016/j.ejogrb.2016.01.03

Management of fetal malposition in the second stage of labor: a propensity score analysis.

OBJECTIVE: We sought to determine the factors associated with selection of rotational instrumental vs cesarean delivery to manage persistent fetal malposition, and to assess differences in adverse neonatal and maternal outcomes following delivery by rotational instruments vs cesarean delivery. STUDY DESIGN: We conducted a retrospective cohort study over a 5-year period in a tertiary United Kingdom obstetrics center. In all, 868 women with vertex-presenting, single, liveborn infants at term with persistent malposition in the second stage of labor were included. Propensity score stratification was used to control for selection bias: the possibility that obstetricians may systematically select more difficult cases for cesarean delivery. Linear and logistic regression models were used to compare maternal and neonatal outcomes for delivery by rotational forceps or ventouse vs cesarean delivery, adjusting for propensity scores. RESULTS: Increased likelihood of rotational instrumental delivery was associated with lower maternal age (odds ratio [OR], 0.95; P < .01), lower body mass index (OR, 0.94; P < .001), lower birthweight (OR, 0.95; P < .01), no evidence of fetal compromise at the time of delivery (OR, 0.31; P < .001), delivery during the daytime (OR, 1.45; P < .05), and delivery by a more experienced obstetrician (OR, 7.21; P < .001). Following propensity score stratification, there was no difference by delivery method in the rates of delayed neonatal respiration, reported critical incidents, or low fetal arterial pH. Maternal blood loss was higher in the cesarean group (295.8 ± 48 mL, P < .001). CONCLUSION: Rotational instrumental delivery is often regarded as unsafe. However, we find that neonatal outcomes are no worse once selection bias is accounted for, and that the likelihood of severe obstetric hemorrhage is reduced. More widespread training of obstetricians in rotational instrumental delivery should be considered, particularly in light of rising cesarean delivery rates.During data analysis, A.R.A. was supported by an NICHD Predoctoral Fellowship under grant number F31HD079182 and by grant R24HD042849, awarded to the Population Research Center at The University of Texas at Austin. She is currently supported by grant R24HD047879 for Population Research at Princeton University. J.G.S. is partially funded by a CAREER grant from the National Science Foundation (DMS-1255187).This is the accepted version. It will be embargoed until 12 months after the final version is published by Elsevier. The final version is available from Elsevier at http://www.sciencedirect.com/science/article/pii/S000293781401078

Vasodilator factors in the systemic and local adaptations to pregnancy

We postulate that an orchestrated network composed of various vasodilatory systems participates in the systemic and local hemodynamic adaptations in pregnancy. The temporal patterns of increase in the circulating and urinary levels of five vasodilator factors/systems, prostacyclin, nitric oxide, kallikrein, angiotensin-(1–7) and VEGF, in normal pregnant women and animals, as well as the changes observed in preeclamptic pregnancies support their functional role in maintaining normotension by opposing the vasoconstrictor systems. In addition, the expression of these vasodilators in the different trophoblastic subtypes in various species supports their role in the transformation of the uterine arteries. Moreover, their expression in the fetal endothelium and in the syncytiotrophoblast in humans, rats and guinea-pigs, favour their participation in maintaining the uteroplacental circulation. The findings that sustain the functional associations of the various vasodilators, and their participation by endocrine, paracrine and autocrine regulation of the systemic and local vasoactive changes of pregnancy are abundant and compelling. However, further elucidation of the role of the various players is hampered by methodological problems. Among these difficulties is the complexity of the interactions between the different factors, the likelihood that experimental alterations induced in one system may be compensated by the other players of the network, and the possibility that data obtained by manipulating single factors in vitro or in animal studies may be difficult to translate to the human. In addition, the impossibility of sampling the uteroplacental interface along normal pregnancy precludes obtaining longitudinal profiles of the various players. Nevertheless, the possibility of improving maternal blood pressure regulation, trophoblast invasion and uteroplacental flow by enhancing vasodilation (e.g. L-arginine, NO donors, VEGF transfection) deserves unravelling the intricate association of vasoactive factors and the systemic and local adaptations to pregnancy

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). Interpretation: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Background: In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation &lt;92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p&lt;0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p&lt;0·0001). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome