Incidence of and risk factors for perineal trauma: A prospective observational study

Background: Our aim was to describe the range of perineal trauma in women with a singleton vaginal birth and estimate the effect of maternal and obstetric characteristics on the incidence of perineal tears. Methods: We conducted a prospective observational study on all women with a planned singleton vaginal delivery between May and September 2006 in one obstetric unit, three freestanding midwifery-led units and home settings in South East England. Data on maternal and obstetric characteristics were collected prospectively and analysed using univariable and multivariable logistic regression. The outcome measures were incidence of perineal trauma, type of perineal trauma and whether it was sutured or not. Results: The proportion of women with an intact perineum at delivery was 9.6% (125/1,302) in nulliparae, and 31.2% (453/1,452) in multiparae, with a higher incidence in the community (freestanding midwifery-led units and home settings). Multivariable analysis showed multiparity (OR 0.52; 95% CI: 0.30-0.90) was associated with reduced odds of obstetric anal sphincter injuries (OASIS), whilst forceps (OR 4.43; 95% CI: 2.02-9.71), longer duration of second stage of labour (OR 1.49; 95% CI: 1.13-1.98), and heavier birthweight (OR 1.001; 95% CI: 1.001-1.001), were associated with increased odds. Adjusted ORs for spontaneous perineal truama were: multiparity (OR 0.42; 95% CI: 0.32-0.56); hospital delivery (OR 1.48; 95% CI: 1.01-2.17); forceps delivery (OR 2.61; 95% CI: 1.22-5.56); longer duration of second stage labour (OR 1.45; 95% CI: 1.28-1.63); and heavier birthweight (OR 1.001; 95% CI: 1.000-1.001). Conclusions: This large prospective study found no evidence for an association between many factors related to midwifery practice such as use of a birthing pool, digital perineal stretching in the second stage, hands off delivery technique, or maternal birth position with incidence of OASIS or spontaneous perineal trauma. We also found a low overall incidence of OASIS, and fewer second degree tears were sutured in the community than in the hospital settings. This study confirms previous findings of overall high incidence of perineal trauma following vaginal delivery, and a strong association between forceps delivery and perineal trauma. © 2013 Smith et al; licensee BioMed Central Ltd

Managing Obstetric Emergencies and Trauma (MOET) structured skills training in Armenia, utilising models and reality based scenarios

BACKGROUND: Mortality rates in Western Europe have fallen significantly over the last 50 years. Maternal mortality now averages 10 maternal deaths per 100,000 live births but in some of the Newly Independent States of the former Soviet Union, the ratio is nearly 4 times higher. The availability of skilled attendants to prevent, detect and manage major obstetric complications may be the single most important factor in preventing maternal deaths. A modern, multidisciplinary, scenario and model based training programme has been established in the UK (Managing Obstetric Emergencies and Trauma (MOET)) and allows specialist obstetricians to learn or revise the undertaking of procedures using models, and to have their skills tested in scenarios. METHODS: Given the success of the MOET course in the UK, the organisers were keen to evaluate it in another setting (Armenia). Pre-course knowledge and practice questionnaires were administered. In an exploratory analysis, post-course results were compared to pre-course answers obtained by the same interviewer. RESULTS: All candidates showed an improvement in post-course scores. The range was far narrower afterwards (167–188) than before (85–129.5). In the individual score analysis only two scenarios showed a non-significant change (cord prolapse and breech delivery). CONCLUSION: This paper demonstrates the reliability of the model based scenarios, with a highly significant improvement in obstetric emergency management. However, clinical audit will be required to measure the full impact of training by longer term follow up. Audit of delays, specific obstetric complications, referrals and near misses may all be amenable to review

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Characteristics, Interventions, and Outcomes of Women Who Used a Birthing Pool: A Prospective Observational Study

Background: Birthing pools are integrated into maternity care in the United Kingdom and are a popular care option for women in midwifery-led units and at home. The objective of this study was to describe and compare maternal characteristics, intrapartum events, interventions, and maternal and neonatal outcomes by planned place of birth for women who used a birthing pool. Methods: A total of 8,924 women at low risk of childbirth complications were recruited from care settings in England, Scotland, and Northern Ireland. Descriptive analysis was performed. Results: Overall, 7,915 (88.9%) women had a spontaneous birth (5,192, 58.3% water births), of whom 4,953 (55.5%) were nulliparas. Fewer nulliparas whose planned place of birth was the community (freestanding midwifery unit or home) had labor augmentation by artificial membrane rupture (149, 11.3% [95% CI: 9.6-13.1]), compared with an alongside midwifery unit (271, 22.7% [95% CI: 20.3-25.2]), or obstetric unit (639, 26.3% [95% CI: 24.5-28.1]). Results were similar for epidural analgesia and episiotomy. More community nulliparas had spontaneous birth (1,172, 88.9% [95% CI: 87.1-90.6]), compared with birth in an alongside midwifery unit (942, 79% [95% CI: 76.6-81.3]) and obstetric unit (1,923, 79.2% [95% CI: 77.5-80.8]); and fewer required hospital transfer (265, 20% [95% CI: 17-22.2]) compared with those in an alongside midwifery unit (370, 31% [95% CI: 28.3-33.7]). Results for multiparas and newborns were similar across care settings. Twenty babies had an umbilical cord snap, 18 (90%) of which occurred during water birth. Conclusions: Birthing pool use was associated with a high frequency of spontaneous birth, particularly among nulliparas. Findings revealed differences in midwifery practice between obstetric units, alongside midwifery units, and the community, which may affect outcomes, particularly for nulliparas. No evidence was found for a difference across care settings in interventions or outcomes in multiparas or in outcomes for newborns. During water birth, it is important to prevent undue traction on the cord as the baby is guided to the surface. © 2012, The Authors Journal compilation © 2012, Wiley Periodicals, Inc