Objective: Description of characteristics, risk factors, management strategies and maternal, obstetric and neonatal outcomes of SARS-CoV-2 infected pregnant women in the Netherlands. Design: Multi-centre prospective nationwide population-based cohort study. Setting: Nationwide. Population: All pregnant women in the Netherlands with confirmed SARS-CoV-2 infection in home-isolation or admitted to hospital between March 1st, 2020 and August 31st, 2020. Methods: Pregnant women with positive PCR or antibody tests were registered using the Netherlands Obstetrics Surveillance System. Testing occurred according to national guidelines (selective testing). Data from the national birth registry (Perined) and Dutch National Institute for Public Health and the Environment (RIVM) were used as reference. Main Outcome Measures: Incidence of pregnant women with SARS-CoV-2 infection. Maternal, obstetric and neonatal outcomes including hospital and critical care admission, clinical management and mode of birth. Results: Of 312 registered women, 65 (20%) were admitted to hospital, of whom 5 (2%) to intensive care and 9 (14%) to obstetric high care units. Risk factors for admission were non-Caucasian background (n=28; OR 6.67, 95%CI 4.08-10.90) and being overweight or obese (n=38; OR 2.64, 95%CI1.51 to 4.61). Hospital and intensive care admission were higher compared to age-matched infected women (respectively, OR 14.57, 95%CI 10.99-19.03 and OR 5.02, 95%CI 2.04-12.34). One maternal death occurred. Caesarean section after labour onset was increased (OR 2.50; 95%CI 1.57-3.97). Conclusions: Pregnant women with SARS-CoV-2 infection are at increased risk of hospital admission, ICU admission and caesarean section. Funding: No funding was received. Keywords: Pregnancy, COVID-19, SARS-CoV-2, Pregnancy complications, Pregnancy outcome, Obstetric surveillance system.
Objective: To estimate the effect of oestrogen-only and combined hormone replacement therapy (HRT) on the hazards of overall and age-specific all-cause mortality in healthy women aged 46 to 65 at first prescription. Design: Matched cohort study. Setting: Electronic primary care records from The Health Improvement Network (THIN) database, UK (1984−2017). Population: 105,199 HRT users (cases) and 224,643 non-users (controls) matched on age and general practice. Methods: Weibull Double-Cox regression models adjusted for age at first treatment, birth cohort, type 2 diabetes, hypertension and hypertension treatment, coronary heart disease, oophorectomy/hysterectomy, body mass index, smoking, and deprivation status. Main outcome measures: All-cause mortality. Results: A total of 21,751 women died over an average of 13.5 years follow-up per participant, of whom 6,329 were users and 15,422 non-users. The adjusted hazard ratio (HR) of overall all-cause mortality in combined HRT users was 0.91 (95%CI 0.88−0.94), and in oestrogen-only users was 0.99 (0.93−1.07), compared to non-users. Age-specific adjusted HRs for participants aged 46-50, 51-55, 56-60, and 61-65 years at first treatment were 0.98 (0.92−1.04), 0.87 (0.82−0.92), 0.88 (0.82−0.93), and 0.92 (0.85−0.98), for combined HRT users compared to non-users, and 1.01 (0.84−1.21), 1.03 (0.89−1.18), 0.98 (0.86−1.12), and 0.93 (0.81−1.07) for oestrogen-only users, respectively. Conclusions: Combined HRT was associated with a 9% lower risk of all-cause mortality and oestrogen-only formulation was not associated with any significant changes. Funding: IFoA. Keywords: Hormone replacement therapy, menopause, mortality, primary care records, THIN. Tweetable abstract: Oestrogen-only HRT is not associated with all-cause mortality and combined HRT reduces the risks.
Objective Assess whether coronavirus disease 2019 (COVID-19) vaccination impacts menstrual bleeding quantity. Design Retrospective cohort Setting Five global regions Populations Vaccinated and unvaccinated regularly cycling individuals using the digital fertility-awareness application “Natural Cycles”. Methods We used prospectively collected menstrual cycle data and multivariable longitudinal Poisson GEE models, multivariable multinomial logistic regression models, and calculated the adjusted difference between vaccination groups. All regression models were adjusted for confounders. Outcome measures Mean number of heavy bleeding days (fewer, no change, more) and changes in bleeding quantity (less, no change, more) at three time points (first dose, second dose, and post-exposure menses). Results We included 9,555 individuals (7,401 vaccinated, 2,154 unvaccinated). About 2/3 of individuals reported no change in the number of heavy bleeding days regardless of vaccination status. After adjusting for confounders, there were no significant differences in the number of heavy bleeding days by vaccination status. A larger proportion of vaccinated individuals experienced an increase in total bleeding quantity (34.5% unvaccinated, 38.4% vaccinated; 4.0% [0.7, 7.2%] adjusted difference). This translates to an estimated 40 additional people per 1,000 normally cycling individuals who experience more total bleeding quantity following the first vaccine dose due to vaccination. Differences resolved in the cycle post-exposure. Conclusion A small increase in the probability of more total bleeding quantity occurs following the first COVID-19 vaccine dose which resolved the cycle post-vaccination cycle. Total number of heavy bleeding days did not differ by vaccination status. Our findings can reassure the public that any changes are small and transie
Sir,We welcome Gurol‐Urganci I and Bidwell et al’s evaluation of the impact of the care bundle to reduce obstetric anal sphincter injury (OASI) published in your August edition last year. The article reports much needed evidence on the efficacy of an intervention that has already taken hold in many maternity services across the country.Despite the article’s timely nature, we would like to voice our disappointment in the quality of the evidence of support for the care bundle Meulen and Thakar et al provide, and the recommendations made. The article fails to consider important evidence in this area of maternity care prompting this response. In particular, the authors miss the opportunity to contextualise the relatively low-level evidence they take from five articles – reporting three Scandinavian cohort studies and one educational intervention study on manual assistance during the final part of the second stage of labour (including gripping the baby’s chin through the perineum) - with the compelling findings from the Cochrane review on Perineal techniques during the second stage of labour for reducing perineal trauma.  This omission is important because the Cochrane review indicates that warm compresses have a bigger positive effect on OASI than the OASI care bundle reported by Meulen and Thakar et al’s. Furthermore, the Cochrane review provides evidence suggesting that hands off the perineum may protect women from episiotomy; an outcome which Meulen and Thakar et al acknowledge remained unchanged despite the third component in the care bundle aiming to ‘use of episiotomy when clinically indicated’. The selective nature of the evidence quoted, undermines the credibility of inferences that can be made from the findings. We suggest therefore, that caution should be taken when reading the authors conclusions.Our second concern rests upon the authors failure to account for the surprisingly small positive effect of the care bundle compared with the Scandinavian studies they quote. Meulen and Thakar et al report a 0.3% decrease in OASI compared with a 3.6% reduction;3% reduction; a 2.6% reduction for low risk women; and a 2.1% reduction in the various observational studies  Such a small effect in an open trial could easily be caused by ascertainment bias. Again, the quality of the previous Scandinavian studies make interpretation difficult but the marked difference in results between Scandinavia and England suggests caution should be taken when reading the authors conclusions.Our final concern pertains to women’s experience of the care bundle. Not only is the acceptability of the intervention not considered in this evaluation – a significant oversight given the conspicuous lack of evidence on this – there are ethical issues within the evaluation that deserve attention. The intervention description in figure 1 claims that women were informed about what could be done to reduce OASI. This does not appear to be entirely true given the lack of consideration of warm compresses and hands off to protect against episiotomy. Even more unsettling is the statement ‘MPP should be used unless the woman objects’, implying little consideration for autonomy and informed consent.For the above reasons, we are not only disappointed with the BJOG article but with the professional stakeholder investment in the intervention which seems to have been widely and uncritically supported, with some support even being somewhat evangelical, despite the limited evidence for support.Signatures,
Background: Science integrity initiatives require specific recommendations for randomised clinical trials (RCT). Objective: To prepare a set of statements for RCT integrity through an international multi-stakeholder consensus. Methods: Following prospective registration (https://osf.io/bhncy, https://osf.io/3ursn), the consensus was developed via: multi-country multidisciplinary stakeholder group composition and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymised two-round modified Delphi survey with consensus threshold based on the average percent of majority opinions; and, a final consensus development meeting. Results: There were 30 stakeholders representing 14 countries from 5 continents including trialists, ethicists, methodologists, statisticians, consumer representative, industry representative, systematic reviewers, funding body panel members, regulatory experts, authors, journal editors, peer-reviewers and advisors for resolving integrity concerns. Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder-provided, 46 systematic review-generated, 8 supported by both) in the initial long list, with 8 additional statements provided during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder-provided, 41 systematic review-generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements including general aspects (n=6), design and approval (n=11), conduct and monitoring (n=19), reporting of protocols and findings (n=20), post-publication concerns (n=12), and future research and development (n=13). Conclusion: Implementation of this multi-stakeholder consensus statement is expected to enhance RCT integrity.
Objective. To externally validate five approaches to predict ectopic pregnancy (EP) in pregnancies of unknown location (PUL): the M6P and M6NP risk models, the two-step triage strategy (2ST, which incorporates M6P), the M4 risk model, and beta human chorionic gonadotropin ratio cut-offs (BhCG-RC). Design. Secondary analysis of a prospective cohort study.Setting. Eight UK early pregnancy assessment units.Population. Women presenting with a PUL and BhCG >25 IU/L.Methods. Women were managed using the 2ST protocol: PUL were classified as low risk of EP if presenting progesterone ≤2 nmol/L; the remaining cases returned two days later for triage based on M6P. EP risk ≥5% was used to classify PUL as high risk. Missing values were imputed, and predictions for the five approaches were calculated post hoc. We meta-analysed centre-specific results. Main outcome measures. Discrimination, calibration and clinical utility (decision curve analysis) for predicting EP.Results. Of 2899 eligible women, the primary analysis excluded 297 (10%) women who were lost to follow-up. The area under the ROC curve for EP was 0.89 (95% confidence interval 0.86-0.91) for M6P, 0.88 (0.86-0.90) for 2ST, 0.86 (0.83-0.88) for M6NP, and 0.82 (0.78-0.85) for M4. Sensitivities for EP were 96% (M6P), 94% (2ST), 92% (N6NP), 80% (M4), and 58% (BhCG-RC); false positive rates were 35%, 33%, 39%, 24%, and 13%. M6P and 2ST had the best clinical utility and good overall calibration, with modest variability between centres.Conclusions. 2ST and M6P performed best to predict and triage PUL.Funding. Research Foundation – Flanders (FWO; G0B4716N), Internal Funds KU Leuven (C24/15/037), NIHR Collaboration for Leadership in Applied Health Research & Care, NorthWest London (RDIP033), NIHR Biomedical Research Centre based at Imperial College Healthcare NHS Trust. Keywords Pregnancy of unknown location, ectopic pregnancy, beta human chorionic gonadotrophin (BhCG) ratio, progesterone, prediction model, prediction model validation
Objective: To explore the duration of the active phase of the second stage of labour in relation to maternal prepregnant body mass index (BMI). Design: Retrospective cohort study. Setting: Labour wards of three Norwegian university hospitals, 2012-2019. Population: Nulliparous and parous women without previous caesarean section with a live singleton foetus in cephalic presentation and spontaneous onset of labour, corresponding to the Ten Group Classification System (TGCS) group 1 and 3. Methods: Women were stratified to BMI groups according to WHO classification, and estimated median duration of the active phase of the second stage of labour was calculated using Kaplan-Meier analyses. We performed stratified analyses in women with and without epidural analgesia and oxytocin augmentation. Finally, we calculated the Hazard Ratio (HR) of delivery using Cox regression analyses. Caesarean sections and operative vaginal deliveries during the active phase were censored. Main Outcome Measures: Estimated median duration of the active phase of second stage of labour. Results: The final study population comprised 23516 women in TGCS group 1 and 27255 in group 3. Increasing BMI was associated with shorter estimated median duration of the active phase in both TGCS groups. The pattern remained when performing stratified analyses for epidural and oxytocin analgesia. The HR for delivery increased significantly with increasing BMI analysed as a continuous variable; HR 1,019 (95%CI 1.016-1.023) in TGCS group 1 and HR 1,017 (95%CI 1.014-1.020) in TGCS group 3. Conclusion: Increasing BMI was associated with shorter estimated median duration of the active second stage Funding: None.
Objective: To investigate the compatibility of oxytocin and tranexamic acid injection products when mixed for the purpose of co-administration by intravenous infusion. Population or Sample: Oxytocin and tranexamic acid were collected from hospitals taking part in a multicentre postpartum haemorrhage treatment (E-MOTIVE) trial in Kenya, Nigeria, Tanzania, and South Africa. Methods: The compatibility of two sentinel products of oxytocin injection and tranexamic acid injection in 200mL infusion bags of both 0.9%w/v saline and Ringer’s Lactate was assessed. We analysed all tranexamic acid -oxytocin combinations, and each evaluation was conducted for up to 6hrs. Subsequently, the compatibility of multiple tranexamic acid products with reference oxytocins products when mixed in 0.9%w/v saline over a period of 1 hour was investigated. Results: We found a significant interaction between certain oxytocin and tranexamic acid products after mixing them in vitro and observing for 1 hour. The interaction substantially impacted oxytocin content leading to reduction in concentration (14.8% - 29.0%) immediately on mixing (t=0 minutes). In some combinations, the concentration continued to decline throughout the stability assessment period. Oxytocin loss was observed in 7 out of 22 (32%) combinations tested. Conclusions: In a clinical setting, mixing oxytocin and tranexamic acid may result in an underdosing of oxytocin, compromising care in an emergency life-threatening situation. The mixing of oxytocin and tranexamic acid injection products for co-administration with IV infusion fluids should be avoided until the exact nature of the interaction and its implications are understood.
OBJECTIVE: To demonstrate that delayed cord clamping (DCC) is safe in mothers with confirmed SARS-CoV-2 infection. DESIGN, SETTING, AND PARTICIPANTS: Prospective, observational study involving epidemiological information from 403 pregnant women with SARS-CoV-2 between March 1st and May 31st, 2020. Data were collected from 70 centers that participate in the Spanish Registry of COVID-19. MAIN OUTCOMES AND MEASURES: The rate of perinatal transmission of SARS-CoV-2 and development of COVID-19 disease in neonates at day 14 of the delivery. RESULTS: The Early cord clamping (ECC) group consisted of 231 infants (57.3%), whereas the DCC group consisted of 172 infants (42.7%). A total of 5 positive cases (1.7% of total tests performed) were identified with the nasopharyngeal PCR tests, 2 from the ECC group (1.7%) and 3 from the DCC group (3.6%). No significant differences between groups were found regarding neonatal tests for COVID-19. No confirmed cases of vertical transmission were detected. The percentage of mothers who made skin-to-skin contact within the first 24 hours after delivery was significantly higher in the DCC group (84.3% versus 45.9%). Breastfeeding in the immediate postpartum period was also significantly higher in the DCC group (77.3% versus 50.2%). CONCLUSIONS: The results of our study have been similar to early cord clamping practices, no skin-to-skin contact, and suppression or delay of breastfeeding. FUNDING: This study was fully funded with public funds from the Institute of Health Carlos III and co-financed with FEDER funds. KEYWORDS: COVID-19, umbilical cord clamping, skin-to-skin, breastfeeding, vertical transmission, safety.
Objective To explore and describe what women who have given birth in Norway emphasise as important aspects of care during childbirth. Design The study is based on data from the Babies Born Better survey, version 2, a mixed-method online survey. Setting The maternity care system in Norway. Study population Women who gave birth in Norway between 2013 and 2018. Method Descriptive statistics were used to describe sample characteristics and to compare data from the B3 survey with national data from the MBRN, using SPSS® software (version 20). The open-ended questions were analysed with an inductive thematic analysis, using NVIVO 12® software. Main outcome measures Themes developed from two open-ended questions. Results The final sample included 8,401 women. There were no important differences between the sample population and the national population with respect to maternal age, marital status, parity, mode of birth and place of birth, except for the proportion of planned homebirths. Four themes and one overarching theme were identified; Compassionate and Respectful Care, A Family Focus, Continuity and Consistency, and Sense of Security, and the overarching theme Coherence in Childbearing. Conclusions Socio-cultural and psychological aspects of care are significant for women in childbirth, alongside physical and clinical factors. Caring for the woman implies caring for her partner and having a baby is about ‘becoming a family or expanding the family’. Childbirth is a continuous experience in women’s lives and continuity and consistency are important for women to maintain and promote a coherent experience.
Objective: This study aims to provide insight into the use, acceptability and outcome of a large group of women who self-managed medical abortion. Design: Retrospective cohort study. Setting: Self-managed abortion worldwide. Population/Sample: 30344 women who completed the follow up from of the telemedical abortion service Women on Web from January 2009 till January 2020. Methods: Analyses of the evaluation forms, binary logistic regressions were performed to test the association between year and outcomes for the total sample. Main outcome measures: Demographic information including age, economic situation, country of living,knowledge about abortion pills and acceptability. Rate of complete abortions, surgical interventions, ongoing pregnancies, blood transfusions per year. Results: 30344 women from 183 different countries completed the follow-up evaluation. In total 26076 women reported taking the medical abortion pills, of which 1.5% reported an ongoing pregnancy, 10.2% a surgical intervention, and 0.6% a blood transfusion. 99% found it to be an acceptable method. 35% found it difficult to make a donation for the service and 8.5% received the service for free. 59.2% reported that they knew about medical abortion before finding Women on Web. We found a significant increase in complete abortions in 2019 (OR= 1.92; 95% CI: 1.59 – 2.31), and decrease in surgical interventions (OR= 0.49; 95%CI: 0.40 – 0.60) compared to 2009. Conclusion: The findings of the outcomes of the 26076 self-managed abortions in this study are in line with previous research , suggesting medical abortion through telemedicine is safe, effective and highly acceptable to women.
Background Antenatal Care (ANC) is one of the key care-packages required to reduce global maternal and perinatal mortality and morbidity Objectives To identify the essential components of ANC and develop signal functions Search strategy MESH headings for databases including Cinahl, Cochrane, Global Health, Medline, PubMed, and Web of Science Selection Criteria Papers and reports on content of ANC published from 2000-2020 Data collection and Analysis Narrative synthesis of data and development of signal function through 7 consensus-building workshops with 184 stakeholders Main Results A total of 221 papers and reports are included from which 28 essential components of ANC were extracted and used to develop 15 signal functions with the equipment, medication and consumables required for implementation of each. Signal functions for the prevention and management of infectious diseases (malaria, HIV, tuberculosis, syphilis and tetanus) can be applied depending on population disease burden. Screening and management of pre-eclampsia, gestational diabetes, anaemia, mental and social health (including intimate partner violence) are recommended universally. Three signal functions adress monitoring of foetal growth and wellbeing and identification and management of obstetric complications. Promotion of health and wellbeing via education and support for nutrition, cessation of substance abuse, uptake of family planning, recognition of danger signs and birth preparedness are included as essential components of ANC. Conclusions New signal functions have been developed which can be used for monitoring and evaluation of content and quality of ANC. Country adaptation and validation is recommended.
Objective: To assess the general population’s knowledge regarding the utility and availability of tools to diagnosis endometriosis, with focus on ultrasound. Design: An international cross-sectional online survey study was performed between August and October 2019. Setting and Population: 5301 respondents, representing 73 countries. Methods: 23 questions survey focused on knowledge of endometriosis diagnosis distributed globally via patient- and community-endometriosis groups using social media. Main outcomes and measures: Descriptive data of the knowledge of diagnostic tools for diagnosing endometriosis, including details about diagnosis using ultrasound. Results: 84.0% of respondents had been previously diagnosed with endometriosis, 71.5% of which were diagnosed at the time of surgery. Ultrasound and MRI were the methods of diagnosis in 6.5% and 1.8%, respectively. 91.8%, 28.8%, and 16.6% of respondents believed surgery, ultrasound and MRI could diagnose endometriosis, respectively (more than one answer allowed). In those diagnosed by surgery, 21.7% knew about ultrasound as a diagnosis method compared to 51.5% knowing in those diagnosed non-surgically (p<0.001). 14.7%, 31.1%, and 18.2% stated superficial, ovarian, and deep endometriosis could be diagnosed with ultrasound (32.9% stated they did not know which phenotypes of endometriosis could be diagnosed). 58.4% of respondents do not believe they could access an advanced ultrasound in their region. Conclusions: There are significant gaps in the understanding of diagnosing endometriosis using non-surgical tools in this study population.
OBJECTIVE: The objective of this study was to evaluate C-section rates, before and after the implementation of the Project Appropriate Birth based on the Robson 10-group classification system. DESIGN: An observational, cross-sectional study. SETTING: Maternity hospital in South Brazil. POPULATION: All pregnant women attending, April 2016 through April 2017 (phase 1, pre-implementation of the Project Appropriate Birth) and June 2017 through June 2018 (phase 2, post-implementation of the Project Appropriate Birth). METHODS: Maternal and obstetric characteristics were evaluated, including Robson’s classification, based on the characteristics of pregnancy and childbirth. Chi-square test and crude and adjusted prevalence ratios were used to analyze study variables. The significance level was set at 5%. MAIN OUTCOME MEASURES: C-section rate for each group, their contribution to the overall c-section rate and the differences in these contributions before and after PPA implementation. RESULTS: C-section rates decreased from 62.4% to 55.6%, which represented a 10.9% reduction after the implementation of the Project Appropriate Birth. Pregnant women in Robson classification groups 1 through 4 had the greatest decrease in C-section rates, ranging from 49.1% to 38.6%, which represents a 21.5% reduction. The greatest contributors to the overall C-section rates were group 5 and group 2, accounting for more than 60% of the C-section deliveries. CONCLUSION: The Project Appropriate Birth had an important impact on the reduction of C-section rates, especially in Robson classification groups 1 through 4, which indicates that providing mothers with evidence-based interventions for labor and childbirth assistance will contribute to reduce C-section rates.
I moved out of our shared bedroom of nearly 10 years on 3/22/2020. It was not a difficult decision as we have two young children and wondered what would happen if both of us became ill at the same time. As a Maternal-Fetal medicine physician in New York City, I was acutely aware of the coming COVID-19 crisis, and its potential ramifications on the health of my family, friends, patients and community. I am trained to function well in emergencies, and in this case, it was a quick and seemingly logical next-step to sleep separately.This decision also comes along with an already in place full-scale decontamination effort that begins as soon as I enter our home. This involves minimizing what jewelry, clothing, food and bags go back and forth between the hospital and my home, 3-shoe changes, stripping off my clothing and placing everything into the wash, and then running to the shower. None of these choices were rooted in years of medical science, given the novelty of the virus, and paucity of data on the SARS-CoV-2 (COVID-19). I used early data regarding transmission as well as anecdotal reports from friends in Asia who seemed to suggest that it was highly contagious and highly transmissible. Thus, when I recently learned that there is a science and a history surrounding how pathogens have shaped human psychological adaptations. As we are forced to confront the longstanding evolutionary pressure of pathogen avoidance regarding what to eat, and touch and who to be intimate with, it no longer feels theoretical.1Looking back at what I’ve gained and what I’m missing over this last month, I am acutely aware of how much less we are touching as a family and in my medical practice, and I miss it. As I say goodnight to my family and retreat to our windowless den, I am both thankful for a place to sleep that is near enough to be able to peek at their beautiful sleeping faces, while sad that I feel less at ease hugging or kissing them. While every health care worker on the front-line of this crisis has drawn different boundaries (some more or less extreme), my decision to sleep in a separate room, create a decontamination routine, and be less physically affectionate with my children was the only way I could feel in control in an uncontrollable situation.Medical professionals know that touch, rooted in the amygdala of the brain, cannot be separated from the expression of empathy and solidarity that it provides.2 In medicine, touch has long been hypothesized to have an impact on health and development over our lifespan. Dr. Cascio and her team at the Vanderbilt Kennedy Center for Human Development describe social touch as “a powerful force in human development, shaping social reward, attachment, cognitive, communication, and emotional regulation from infancy and throughout life.3” Many of the babies of the mothers I care for will begin their lives in the Neonatal Intensive Care Unit where the science surrounding touch as part of healthcare is widely accepted and engrained in the culture. Skin-to-skin and kangaroo care, the act of carrying your child in a pouch-like device, have been shown to improve breastfeeding, bonding, and neurocognitive development4,5 In fact, the World Health Organization currently has an ongoing international trial looking at the benefits of survival on low-birthweight infants of kangaroo care initiated immediately after birth on survival of low birth weight infants.6 Later in life, touch, relationship quality and intimacy continue to drive good health and have been associated with improved cognitive function in the Rotterdam Study7,8and improved cardiovascular outcomes in the National Social Life Health and Aging Project.8 Their findings suggest physical touch may have positive health implications for older adults.Prior to the pandemic, physicians were already sounding alarms about the loss of medical touch in modern medicine. In a 2011 TED talk with over 1.7 million views, renowned author and physician Abraham Verghese discussed the power of physician touch and the physical exam as he tried to revive the culture of bedside medicine.9 With this pandemic all of that has changed. We are all exceedingly careful to prevent transmission and yet try to provide care and solace in new ways. At the bedside, a gloved hand continues to provide care and comfort. I am happily finding ways to connect with patients through smiling eyes behind a mask, and jokes or phrases that now replace touch. I find myself more commonly expressing words of empathy in telemedicine visits to fill in for the gaps that touch might have provided before. I ask many, many questions to understand symptoms if I cannot see the patient in person. Due to the surrounding events, I am undertaking the fulfilling process of learning a new skill in medicine, to express my emotions on a screen and affect patients’ lives in ways similar to that of an in-person visit.As we raise our family in this time of pandemic, I am thankful that my husband is doing “double-duty” in the realm of hugging and kissing, and has always been a physically affectionate father to our children. I try to tell them how much I love them with greater frequency and despite the concerted effort there are days it’s almost impossible to share our apartment without being physically close. The psychological impact this crisis will have on them is yet to be determined. I hope time will find them healthy, more resilient and grateful at the end of this journey.But tonight, as they sleep soundly in their beds for another night, I am still saddened that I’m not doing the usual kissing and hugging as I tuck them into bed, and it feels like a true loss, among the many others. I am not sleeping as soundly these days for a multitude of reasons including the guest bed, the strangeness of being alone after so many years, and the exponential rise in screen time for work and media consumption. I am truly hopeful we will return to a time when we can more freely touch and care for the people we love and the patients we value so much. In the simplest of internet searches, touch has so many definitions. Touch can mean to be in close contact, but it can also mean to affect.10 COVID-19 has affected us in innumerable ways, and as healthcare workers navigate a post-COVID landscape, I’m hopeful we can continue to innovate and find safe ways to incorporate medical touch into a practice that will be forever changed.Acknowledgements : I would like to acknowledge our patients for their immense flexibility in this changing landscape, the support of my division and department, and my family. I’d like to thank Dr. Gwendolyn Quinn and my husband David Lee, for their significant editorial assistance.
Objective: To review the effect of the COVID-19 pandemic on the presentation of Cervical cancer. Design/ Setting: Retrospective study involving the Regional Cancer Centres in the M62 Group. Methods: Data was collected for two equal time periods. All cervical cancers were included and FIGO 2018 staging was used for the data collection. P values were calculated using binomial hypothesis test for the difference in staging. Time from symptoms to diagnosis was assessed using a normal distribution test. All other calculations were performed using chi-squared test. Statistical significance was considered if p values were <0.05. Main outcome measures: Histology, stage at diagnosis, date of onset of symptoms, investigation and type of treatment. Results: A total of 406 cases of cervical cancer were reviewed; 233 from May – October 2019 (pre-COVID) and 173 between May – October 2020 (post COVID); representing a significant reduction in new cervical cancer diagnoses of 25% post COVID (p<0.001) There was a 42% increase in the delay from start of symptoms to diagnosis Post COVID. Pre COVID, 27% of patients presented with Stage 3 or 4 disease, whilst during COVID this was 38%; statistically significant (p <0.001). When we evaluated the treatments received between the two time periods, this was also statistically significant (chi-squared, p=0.0005). Conclusions: This study has demonstrated a statistically significant increase in the stage of cervical cancer at diagnosis and a change in treatment for cervical cancer following the onset of COVID-19. The implications of this are discussed.
In November 2019, section 4.6 of the ondansetron Summary of Product Characteristics (SmPC) was revised by the European Medicines Agency (EMA). It explicitly states, “ondansetron should not be used during the first trimester of pregnancy” (Ondansetron, SmPC[cited 2020 July 08]. Available from: https://www.medicines.org.uk/emc/). Ondansetron is an effective antiemetic drug commonly prescribed as a second-line treatment for severe Nausea and Vomiting of Pregnancy (NVP) (Fiaschi L et al,BJOG 2019;126:1201–11; Oliviera L et al. Obstet Gynecol2014;124:735-42). We do not believe that the underlying evidence supports a strong regulatory discouragement.Tightening of the SmPC on the use during pregnancy follows EMA assessment of two large pharmacoepidemiological studies, each comprising more than 80,000 first trimester pregnancy exposed liveborn children.In a methodologically meticulous pharmacoepidemiological study, Huybrechts et al. studied malformation outcomes among 88,000 liveborn children exposed to ondansetron in the first trimester. Comparing to 1,727,000 unexposed liveborn, they used comprehensive propensity score adjustments for their inferential analysis. Adjusted relative risks were 1.01 (95% CI 0.98-1.05) for any malformation, 0.99 (95% CI 0.93-1.06) for cardiac malformations and 1.24 (95% CI 1.03-1.48) for oral clefts (Huybrechts et al. JAMA 2018;320:2429–37).Subject to substantial academic controversy, Zambelli-Weiner et al. reported data on 82,000 liveborn children exposed to ondansetron in the first trimester (Zambelli-Weiner et al. Reprod Toxicol2019;83:14–20). Overall, they reported a small excess risk of cardiac malformations with an adjusted odds-ratio (aOR) of 1.04 (95% CI 1.00-1.08) and a weak association with orofacial clefts, aOR 1.12 (95% CI: 0.95-1.33). When restricting exposure to about 5,500 women who were administered ondansetron in a hospital setting, the vast majority of which comprised a single intravenous dose, aOR was 1.43 (95% CI 1.28-1.61) for cardiac malformations and 1.30 (95% CI: 0.75-2.25) for orofacial clefts. This study is substantially flawed and we argue it should not be considered when weighing the totality of evidence on the safety of ondansetron in pregnancy due to: 1) strong selection bias 2) poor external validity (the cardiac malformation rate of 3.7% was extraordinarily high among 780,000 unexposed controls) 3) inadequate adjustment for confounders and covariates and, importantly, 4) serious conflict of interest (Schachtman Law. Re: Zambelli-Weiner [cited 2020 July 8]. Available from: http://schachtmanlaw.com/litigation-science-in-re-zambelli-weiner/ )In summary, robust clinical data suggest 1) no overall increased risk of major malformations 2) no increased risk of cardiac malformations 3) a small excess risk of oral clefts corresponding to three additional cases of oral cleft for every 10,000 liveborn children exposed to ondansetron in the first trimester of pregnancy (figure 1).NVP causes significant physical and psychological morbidity to the degree that some women contemplate termination of pregnancy. Denying such patients effective and low-risk treatment is inappropriate. We are confident that women suffering from severe NVP can comprehend the small excess risk of oral clefts in making an informed decision. The statement “ondansetron should never be used in pregnancy” is: 1) misconceived 2) insufficiently substantiated by evidence and 3) not in the best interest of pregnant women.