Dear Editor, We really appreciate MN van Ĳsselmuiden et al. for their efforts in conducting the first ever multicenter randomized controlled trial to compare laparoscopic sacrohysteropexy (LSH) with sacrospinous hysteropexy (SSHP).1 However, I have some questions regarding the methodology and results of this trial. What are the reasons for including patients with histories of previous pelvic floor or prolapse surgery in the exclusion criteria? Would randomly and equally allocating these patients into two surgical groups affect the study result or design? Nevertheless, we are really interested in the conduct of anterior or posterior colporrhaphy through the laparoscopic method.Patients presented with anterior vaginal wall prolapse are higher in number: POP-Q stage- Aa or Ba > 0 (LSH group:81%; SSHP group:72.6%) than those presented with apical prolapse (LSH group:46.6%; SSHP:45.6%) in Table 1. The majority of study population appears to have combined anterior and apical compartment prolapse rather than apical prolapse alone. Furthermore, Table 2 shows that the overall anterior compartment failure rates are 50.9% and 56.9% in the LSH and SSHP groups, respectively, in a 1 year follow-up interval. The failure rate is extraordinarily high compared with that in a previous study.2 Hysteropexy surgery is beneficial for patients with apical prolapse. It is not beneficial for patients with combined anterior and apical compartment prolapse with prominent cystocele. Most patients are satisfied with the 1 year surgical results and would recommend surgery to someone else (LSH: 87.7%; SSHP: 89.7%) despite the high recurrence rate of anterior wall prolapse in a 1 year follow-up.In the statistical analysis section, additional anterior vaginal wall repairs are significantly higher in the SSHP group than those in the LSH group (SSHP: n = 61, 98.4%; LSH: n = 55, 85.9%, P = 0.010). I would like to know how this small number difference (61 − 55 = 6) in these groups can cause significant difference in P value and how this P value is calculated. This trial assumes a failure rate of 3% on the basis of the outcomes of SSHP in a previous prospective study. However, the data population is relatively small, and the non-inferiority margin was set at 10%.The primary outcome is defined as a composite outcome of the surgical failure of the apical compartment after 12 months of follow-up and as the recurrence of uterine prolapse (POP-Q ≥ stage 2). Surgical success is defined as the absence of prolapse beyond the hymen. In the POP-Q stage system, POP-Q stage 2 is defined as the most distal prolapse between 1 cm above and 1 cm beyond the hymen.3 The most prominent prolapse, which descends beyond hymen, is the stage 2 prolapse. It elicits clinical controversy and conflicts with regard to the definitions of surgical failure and success. We hope that this letter will deliver the message that precise preoperative patient selection and study design are crucial, as they may have substantial impacts on clinical outcomes and treatment success.Min-syuan Huang,2, 3 Zi-Xi Loo,1Kun- Ling Lin,1, 2 Cheng-Yu Long1, 21 Department of Obstetrics and Gynecology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan2 Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan3 Department of Obstetrics and Gynecology, Kuo General Hospital, Tainan, Taiwan
Dear Sir, Whilst the primary focus of our commentary was to reflect upon the multitude of clinical and institutional changes prompted by COVID-19 to help adopt a more streamlined approach to healthcare,1we thank Herron et al for highlighting the importance of partner support during labour.2 However, we note that even during the peak of the first wave of infections, the Royal College of Obstetricians and Gynaecologists (RCOG) continued to advocate the presence of a single birth partner throughout labour. Many obstetric units, including our own, managed to successfully adhere to this practice throughout the pandemic. However, guidance from the RCOG for women attending antenatally, for face to face clinic appointments or ultrasound scans, was to attend alone. This was subsequently implemented in most hospitals in order to reduce the number of visitors.1 Whilst necessary during the initial fear and uncertainty surrounding COVID-19, moving forward it is important to consider the potential negative impact of partner non-attendance antenatally, as well as intrapartum. Partners often positively encourage women to seek care and prepare for birth complications, thereby preventing delay in treatment and helping to manage expectations, which have been shown to positively impact outcomes.3 Whilst undoubtedly an exciting time for many, pregnancy and the prospect of motherhood is daunting to others. Partners provide support and facilitate decision making throughout the antenatal process, particularly in difficult circumstances such as following the diagnosis of a missed miscarriage, during counselling for pregnancies affected by genetic abnormalities, or after an intrauterine death. The restrictions on partner attendance may therefore inadvertently prevent a number of women seeking care during pregnancy, for fear of having to face procedures or receiving bad news alone. Evidence from a London hospital supports this notion after demonstrating a significant increase in stillbirth rate during the pandemic compared to pre-pandemic (9.31 per 1000 births Vs 2.38 per 1000 births; p=0.01). Of significance, no cases were affected by COVID-19, nor were there any post-mortem findings suggestive of the virus.4The utilisation of remote consultations with a woman and her partner offers a suitable option in appropriately triaged cases.1 Even in remote consultations where inadvertent difficult decisions arise, the presence and support of their partner facilitates collaborative decision making. Ironically, those with high risk enough pregnancies to warrant in person consultations, where additional support could offer significant value, are those whereby partners are not permitted. Prior to the pandemic, partners often reported feeling excluded, fearful of the uncertainty of pregnancy and labour and frustrated by perceived lack of support from healthcare professionals.5 This may subsequently negatively impact their relationship because of the inability to adequately support their partners. Their exclusion from the majority of antenatal care therefore, may not only negatively impact psychological wellbeing of women which may in turn result in suboptimal outcomes, but also negatively impact their future relationship. As such, we agree with Herron et al and support their notion that attempts should be made towards delivering individualised patient centred care both antenatally and intrapartum.Lorraine S Kasaven1,2, Srdjan Saso1,2, Jen Barcroft1,2, Joseph Yazbek1,2, Karen Joash1, Catriona Stalder1, Jara Ben Nagi,2 J Richard Smith,1,2 Christoph Lees1,2, Tom Bourne1,2, Benjamin P Jones1,21 Queen Charlotte’s and Chelsea Hospital, Department of Cancer and Surgery, Imperial College NHS Trust, W12 0HS London, UK.2 Imperial College London, Department of Cancer and Surgery, London W12 0NN, UK.
Dear Editor in ChiefWe read with interest “The outcome of pregnancy in women with cystic fibrosis: a UK population based descriptive study1.” We thank the authors for this timely paper which highlights the growing need for robust clinical data capture for Cystic Fibrosis maternal and infant health.This is a rapidly expanding area of interest as the landscape of CF care is changing dramatically, particularly in the era of CFTR modulation. Clinical teams caring for people living with CF are increasingly being asked about pregnancy and potential risks to mothers and their babies. As the authors highlight data on pregnancy in CF historically has mainly been small case series from single sites carried out before CFTR modulators were widely available. The guidelines referenced are somewhat dated as the authors allude to.The authors describe the strength of the data collection in the form of the UK OSS. However, over the 24 month period only 71 cases are collected. The authors also reference around 30 -40 women with CF being pregnant per year in the UK.* We suspect that there are a significant proportion of missing cases within this study suggested by an interrogation of the UK CF Registry data. The UK CF Registry has been sponsored and hosted by the CF Trust since 2007. CF clinical care teams enter data at every specialist centre and clinic across the UK, with over 99% of people with CF consenting to their data being submitted. Data from the UK CF Registry over the time period reported by this study revealed 64, 71 and 58 women having babies in 2015, 2016 and 2017 respectively. Although it is not possible to exactly match the dates (March 2015 to February 2017) described within this study to the CF registry data it is likely that there were considerably more than 71 cases in a two year period. **There remain queries regarding the clinical details of those women reported in this study. Eight of the 71 (11%) had no underlying CFTR mutation available and 51% were reported as pancreatic sufficient which is much higher than would be expected from a cohort of adults with CF in the UK. For 15 of the women included in the case series, lung function is not described.One of the main conclusions of the paper is that gestational age is highly correlated with FEV1. We find the presentation of this misleading as this is most likely the case because women with poorer lung function had pre-term caesareans or had labour induced earlier. Although this doesn’t change the correlation it may mean that it is due to the intervention.There is an ongoing UK Government funded project, CF Prosper, looking at pregnancies in women with CF using UK CF Registry and US CF Foundation registry data from 2003 to current (https://cfprosper.yolasite.com). We expect to be able to report on over 1000 pregnancies and help to delineate predictive factors for successful pregnancies and examine subsequent maternal disease trajectory after starting a family. Using the largest dataset yet available we also hope to develop a decision-making tool in conjunction with women living with CF and their clinical care teams to enable women with CF to make more informed choices regarding pregnancy and starting a family.Yours faithfully,Jamie Duckers, Cardiff and Vale University Health Board, UKDaniela Schlueter, Liverpool University, UKRhiannon Phillips, Cardiff Metropolitan University, UKRebecca Cosgriff, Cystic Fibrosis Trust, UKEsan Oluwaseun, Liverpool University, UKShantini Paranjothy, Aberdeen University, UKDeni Williams, Cardiff Metropolitan University, UKRachel Norman Cardiff and Vale University Health Board, UKDavid Taylor Robinson, Liverpool University, UKSiobhan Carr, Royal Brompton Hospital, London UK1) Ashcroft A, Chapman SJ, Mackillop L. The outcome of pregnancy in women with cystic fibrosis: a UK population-based descriptive study. BJOG. 2020 Jul 19. doi: 10.1111/1471-0528.16423. Epub ahead of print. PMID: 32683738.*There appears to be an error in the referencing numbering within the article as no reference 13 exists**Details on how to request data from the UK CF Registry are available via www.cysticfibrosis.org.uk/registry
Dear Sir,We read with interest Kasaven et al., (1) who eloquently describe some of the implications to the practice of obstetrics and gynaecology. They correctly identify the heightened anxiety that patient’s face when attending hospital during pregnancy. During this time the reduction in patient attendance can be multifactorial. However, we feel one area which has been neglected is partner support. There is evidence that having a partner present during a birth can reduce a woman’s anxiety and additionally be beneficial to the partner (2). Father’s also can experience significant anxiety in the peri-natal period (2) and maternal stress particularly with relationship strain can be harmful to the baby. Parental presence during CPR for a child is beneficial for parents as they can make sense of the situation. It logically would also be beneficial to partners with maternal emergency caesarean sections and of course postnatally to bond with the baby (3). Current policy dictates that fathers can only be present during the birth, however in a multiparous woman or a woman requiring a crash caesarean section the timeframe allowing for partner’s attendance is not reasonable or feasible. COVID-19 is clearly the reason for this policy, however, examining the risk of a couple, who have both been screened as negative on a COVID-19 test and live in the same household. If the male member of the couple has COVID-19 the female is likely to have a high viral load from the partner due to kissing or sexual intercourse (4), a common practice in an attempt to induce labour. The early knowledge of infection can allow for appropriate infection control measures to be put in place. The rate of a false negative is 4-30% (4) but this is still a risk with the mother. The risk to staff with correct personal protective equipment and training is minimal (4). Additionally, women who do not have continuous support are more likely to have an instrumental/surgical delivery, use more pain medication, prolonged labours which may result in complications such as postpartem haemorrhage (5), which ultimately places hospitals and clinicians at greater risk of litigation. With risk of domestic violence and risk of increased mental health issues as highlighted by Kasaven et al., are we doing more harm than good and is this an unintended consequence of COVID-19 that could be prevented? The implication to patient care is huge for what appears to be little benefit. Have we forgotten that we should be delivering patient centred care? Perhaps it is time for change.Herron JBT (1), Herron RL (2)1. University of Sunderland, Faculty of health science and wellbeing, Chester Road, Sunderland SR1 3SD.2. Northumbria University, School of Nursing, Midwifery and Health, 2 Sandyford Rd, Newcastle upon Tyne NE1 8QH.
The American obstetrician, Joseph DeLee, ‘father of modern obstetrics’, founded the Chicago Lying-in Hospital in 1931 with his vision for womens’ health captured in a set of five stone plaques at the top of the cloister of the hospital’s building. Four of the five stone plaques are engraved with the names of pioneering clinicians whose contributions to the field of obstetrics and gynaecology have been seminal: Jan Palfyn (1650-1730), for introducing the obstetric forceps in the 1720s, Hendrik Van Deventer (1651-1724), for discovering obstetric anatomical disorders, William Smellie (1697-1763), for improving the design of the forceps, and Eduardo Porro (1842 –1902), for introducing hysterectomy to stop postpartum haemorrhage. The fifth stone plaque, in the centre, which is still blank today, is reserved for the physician/scientist who discovers the cause and cure of preeclampsia according to legend.That clusters of preeclamsia occur in family units prompted the question whether preecclampsia is an inherited disorder, and if so, what is the mode of inheritance? Familial clustering opened the possibility of deploying genome wide association studies (GWAS) for the identification of candidate genes and susceptibility loci for the development of preeclampsia and researchers have focused on this question since the discovery of DNA. However, till date, there has been no clearly defined causal relationship between a preeclampsia genotype and phenotype except for heterozygous women who are pregnant with long-chain hydroxyacyl-CoA dehydrogenase deficient fetus who have nearly 80% chance of developing HELLP syndrome or acute fatty liver of pregnancy. Defining the genetics and mode of inheritance of preeclampsia is challenged in part by the involvement of two genomes (maternal and fetal), and a wide spectrum of women who meet the diagnostic criteria according to the International Society for the Study of Hypertension in Pregnancy.There is persuasive literature that coexisting maternal medical disorders such as diabetes, chronic hypertension, renal disease, autoimmune disease, antiphospholipid antibody syndrome and other maternal-fetal risk factors including obesity, dyslipidemia, nulliparity, previous/family history of preeclampsia, and multifetal gestation, increase the risk of preeclampsia. In this issue of the Journal, Gray and colleagues (BJOG 2020 xxxx) used single nucleotide polymorphisms (SNPs) for 21 distinct clinical traits for increased risk of preeclampsia within 7 categories (cardiovascular, inflammatory/ autoimmune, insulin resistance, liver, obesity, renal, and thrombophilia) from the European GWAS to test the hypothesis that women with genetic predisposition to these disorders would have increased risk of preeclampsia in a case/control sample of data from the largest known US preeclampsia GWAS. The authors’ findings that; a) risk alleles for raised diastolic blood pressure and increased BMI were strongly associated with preeclampsia risk (more so for the early-onset disease variant), b) risk alleles for raised alkaline phosphatase levels, increased HDL, GFR, and venous thromboembolism were protective, and c) no significant associations for the other traits examined, are consistent with the current status of preeclampsia and HELLP as highly complex disorders with variable clinical presentations depending on pre-pregnancy maternal conditions, fetal/placental genotypes, and maternal adaptation to the challenge of pregnancy.So, preeclampsia is far from a Mendelian inherited type of genetic disease and the search for its cause and cure continues 90 years after DeLee’s vision!Conflict of interest: None. A completed disclosure of interest form is available to view online as supporting information.
Tweetable abstract: Identical twin pregnancies have more preterm births and other complications than fraternal twin pregnancies.Mini-CommentaryA decade ago, Professor Kypros Nicolaides of Kings’ College opined, “There is NO diagnosis of twins. There are only monochorionic or dichorionic twins. This diagnosis should be written in capital red letters across the top of the patient’s chart.” (Quoted by Moise and Johnson, Am J Obstet Gynecol 2010; 203:1-2.) To make this diagnosis, it is essential to establish chorionicity as early as possible in every twin pregnancy.Monochorionic twin pregnancies have long been known to have higher rates of miscarriage, congenital anomalies, stillbirth, and neonatal death than dichorionic twin pregnancies. Intertwin vascular anastomoses are present in most monochorionic twin placentas, leading to complications such as twin-twin transfusion syndrome (TTTS), twin anemia-polycythemia sequence (TAPS), twin reversed arterial perfusion (TRAP) sequence, and unequal placental sharing (UPS).Monochorionic twins require intensive antenatal surveillance. Because of the increased risk of congenital anomalies, fetal echocardiogram is recommended in addition to routine ultrasound fetal anatomy survey. Because of the risk of TTTS, TAPS, TRAP and UPS, sonographic surveillance is recommended every 2 weeks starting at 16 weeks of gestation. Because of the risk of stillbirth, serial antenatal cardiotocography is recommended. Scheduled delivery is recommended earlier for monochorionic twins than for dichorionic twins (NICE Guideline 137, 2019; ACOG, Obstet Gynecol 2019;133:e151-5; Cheong-See et al, BMJ 2016;354:i4353).Regardless of chorionicity, 60% of twins are born preterm, resulting in substantial perinatal morbidity and mortality. Prevention of preterm birth (PTB) is a major priority for management of twin pregnancy.The systematic review by Marleen and colleagues is the first of several studies planned by the authors to evaluate risk factors for PTB in twin pregnancy. Prior reports have suggested that monochorionic twins have higher rates of PTB than dichorionic twins but, as the authors note, there has been no prior systematic review of this association. It is not surprising that the review shows an increased overall rate of PTB among monochorionic twins in all gestational age ranges, given that complications such as stillbirth, TTTS, TAPS, TRAP, and UPS often result in iatrogenic PTB. Indeed, iatrogenic PTB before 37 weeks of gestation should be routine for monochorionic twins because of the increasing risk of stillbirth past 36+6 weeks cited in the current NICE Guidelines (2019, op. cit .). However, Marleen and colleagues also report that spontaneous PTB at <37 weeks and ≤34 weeks is increased in monochorionic twin pregnancy, which cannot be directly explained by monochorionic placental complications.The overarching goal of Marleen and colleagues is to develop tools to predict which twin pregnancies are at risk of PTB so that preventive measures can be taken. Unfortunately, it is not currently known what preventive measures will reduce the high risk of early spontaneous PTB among monochorionic twin pregnancies. Prophylactic bedrest, hospitalization, uterine activity monitoring, tocolysis, cerclage, cervical pessary, and progestogens have not proven effective for unselected twin pregnancies. Future research will be needed to determine the value of such interventions for women with twin pregnancy plus additional risk factors such as a short cervix, prior PTB, or monochorionicity.Acknowledgements: NoneDisclosure of Interests: C Andrew Combs declares “No relevant or competing interests”Contribution to Authorship: CAC did 100% of the planning, writing, and submission.Details of Ethics Approval : Not applicableFunding: NoneReferences: Cited in-line per instructions for Mini-CommentaryTables/Figures: None
Virtual Reality for Acute Pain in Outpatient Hysteroscopy: A Randomised Controlled Trial We would like to thank E.Mirza and colleagues for their interest in our study, Virtual Reality for acute pain in outpatient hysteroscopy: A randomised controlled trial.We would like to point out that in light of the fact that the sample size was limited to 40 patients, the interpretation of further subgroup analysis is likely to be limited.On further analysing patients we noted that a total of 7/40 (18%) which included 3 in the Standard Procedure (SP) arm and 4 in the Virtual Reality (VR) arm, had had a previous outpatient hysteroscopy. The mean expected pain scores in the VR and SP groups were comparable (VR group was 6.5 and in the SP group was 7) however the perceived average pain scores were 2.25 and 6.3 respectively. This would suggest that VR might have had a beneficial effect despite a previous experience of OPH.We appreciate that patient’s pain thresholds are variable and that it is a very subjective experience. 2 patients in the VR group reported average pain scores of 0 whilst all patients in the SP group experienced some degree of pain. It is difficult to ascertain how much VR contributed to the experience in the context of the patient’s tolerance to pain. We agree that future studies looking into patients with painful hysteroscopies would most benefit from additional pain relief strategies and would be of immense clinical value.Analgesic intake included paracetamol, non steroidal anti-inflammatory drugs, cocodamol either on their own or in combination and the numbers of patients receiving analgesics was comparable across the two groups. However we do not have data on dosages and how long before the procedure the analgesics were taken. We acknowledge that standardisation of analgesics intake would have helped in understanding the actual impact of VR in pain relief.1,2 We agree with these suggestions for future directions of research in this area and the suggested improvements to methodology.Claustrophobia was not an exclusion criterion in our study and hence one patient was recruited but nevertheless only experienced the intervention of a short period of time before she took the VR goggles off. We note recent studies, which have used VR for treatment of claustrophobia.3,4 The outcomes are normally reported taking an Intention to Treat approach. We repeated a regression analysis after removing the patient in question, and the experimental group still reported significantly lower pain and anxiety scores for those patients receiving the VR intervention.Nandita Deo 1,2Khalid Saeed Khan4Jonathan Mak 4John Allotey3Francisoco Jose Gonzalez Carreras 3Gianpaolo Fusari 5Jonathan Benn 6Imperial College London, UK1Whipps Cross University Hospital, London, UK2The London School of Medicine and Dentistry, London, UK3Queen Mary University, London, UK.4Helix Centre, Imperial College London and the Royal College of Art, London, UK 5School of Psychology, University of Leeds, UK6Corresponding Author- Nandita Deo MBBS, MD, FRCOG, MSc (Health Care and Design)Consultant Obstetrician and GynaecologistWhipps Cross University Hospital, Barts Health NHS Trust,Leytonstone, London, E11 1NRTel: 0044 firstname.lastname@example.org. De Silva PM, Mahmud A, Smith PP, Clark TJ. Analgesia for office hysteroscopy: systematic review & meta-analysis. Journal of Minimally Invasive Gynecology. 2020 Jan;S1553465020300467.2. Ghamry NK, Samy A, Abdelhakim AM, Elgebaly A, Ibrahim S, Ahmed AA, et al. Evaluation and ranking of different interventions for pain relief during outpatient hysteroscopy: A systematic review and network meta-analysis. J Obstet Gynaecol Res. 2020 Jun;46(6):807–27.3. Carl E, Stein AT, Levihn-Coon A, Pogue JR, Rothbaum B, Emmelkamp P, et al. Virtual reality exposure therapy for anxiety and related disorders: A meta-analysis of randomized controlled trials. J Anxiety Disord. 2019;61:27–36.4. Rahani VK, Vard A, Najafi M. Claustrophobia Game: Design and Development of a New Virtual Reality Game for Treatment of Claustrophobia. J Med Signals Sens. 2018 Dec;8(4):231–7.
The paper by Mulder et al. addresses the effect of pregnancy prolongation on maternal and fetal outcomes in women with early-onset pre-eclampsia diagnosed after 24 weeks of gestation (Mulder et al., BJOG 2020 xxxx). They report that pregnancy prolongation - from the time of pre-eclampsia diagnosis to delivery - is associated with improved offspring outcome and survival, without adverse consequences on short-term maternal cardiovascular and metabolic function. The maternal findings are apparently at odds with another recent study from New York (Rosenbloom et al. Obstet Gynecol 2020;135:27-35) which observed an increased risk of maternal cardiovascular events after pregnancy, in case of an interval of more than 7 days between the diagnosis of any hypertensive disorders of pregnancy and delivery.Some issues should be pointed out in order to avoid misunderstandings about these findings. Being Mulder et al.’s an observational study, readers cannot infer causality because women were not randomized to the length of pregnancy prolongation. Data are spread over a significant time period (from 1996 to 2017), and this aspect could be another confounder. Pre-eclampsia is a multi-organ syndrome based on chronic inflammation, oxidative stress and endothelial dysfunction leading to a persistent subclinical cardiovascular impairment and an increased risk of adverse events later in life (Sciatti et al., Eur J Prev Cardiol 2020 doi: 10.1177/2047487320925646), similarly to what happens in cases with heart failure with preserved ejection fraction. Myocardial geometry and ejection fraction are not sensitive enough to be altered by just a few days of pregnancy prolongation, and to forecast cardiovascular consequences. Only innovative techniques such as speckle-tracking imaging may document an impairment in myocardial contractility and relaxation in former pre-eclamptics, even if ejection fraction is normal.Pre-eclampsia is currently defined as new-onset hypertension combined with de-novo proteinuria and/or “adverse conditions” or “severe maternal/fetal complications” (Magee et al., Pregnancy Hypertens 2014;4:105-145). International guidelines recommend that women with severe forms of pre-eclampsia should be delivered immediately regardless of gestational age, while an expectant management should be considered for women with non-severe pre-eclampsia before term (Magee et al., Pregnancy Hypertens 2014;4:105-145; NICE guideline no. 133, 2019). Delaying delivery is expected to benefit newborn’s health, which is well exemplified by Mulder et al.’s findings. However, the fetus is often the protagonist of adverse conditions, and severe complications such as fetal growth restriction, often co-exist with early-onset pre-eclampsia, requiring longitudinal monitoring with Doppler ultrasound and cardiotocography. The timing of delivery depends on both maternal and fetal conditions. The lack of data about fetal growth and Doppler and cardiotocography findings (in cases with growth restricted babies) limits the generalisability of the results by Mulder et al. One would expect that a longer delay before delivery can be attained only in fetuses and mothers with milder clinical manifestations of disease.Word count: 455
Mini-commentary on BJOG-20-0320.R1: Cesarean section in the second delivery to prevent anal incontinence after asymptomatic obstetrical anal sphincter injury: the EPIC multicenter randomized trialAn obstetric anal sphincter injury poses an important clinical dilemma for subsequent vaginal deliveries, which may be complicated by recurrent obstetric anal sphincter injury and / or worsening or de novo anal incontinence.Recurrent obstetric anal sphincter injury has a similar incidence to primary obstetric anal sphincter injury (6.3% vs 5.7%), and similar associated risk factors including instrumental delivery with either forceps [OR 3.12, 95% confidence interval (CI) 2.42-4.01) or ventouse (OR 2.44, 95%CI 1.83-3.25), birth weight ≥4 kg (OR 2.29, 95%CI 2.06-2.54) and previous fourth-degree tear (OR 1.7, 95%CI 1.24-2.36) (Jha S, Parker V: Int Urogynecol J. 2016 Jun;27(6):849-57).The risk of long-term anal incontinence is also related to the degree of sphincter tear. Women with a fourth-degree sphincter injury in the first delivery are at higher risk for anal incontinence compared to women with a third-degree injury (58.8% vs. 41.0%). (Jangö H et al. 2018 Feb;218(2):232.e1-232.e10. Am J Obstet Gynecol). Although primary caesarean may be protective against anal incontinence, the previous observational evidence is consistent in finding that adjusted odds of long-term anal incontinence do not differ significantly by mode of second delivery after obstetric anal sphincter injury, and specifically that subsequent elective cesarean delivery is not protective (Jangö H et al, Am J Obstet Gynecol. 2016;214(6):733.e1-733.e13.) However, previous observational studies may suffer from confounding by indication, due to widespread adoption of planned caesarean for subsequent deliveries in women with incontinence symptoms or persistent sphincter defectsThere have been no previous randomised trials to test whether anal incontinence could be prevented by planned cesarean section for the second delivery. Abramowitz and colleagues’ (Abramowitz L et al. BJOG 2020) RCT provides us with a better understanding of the role of caesarean in women with asymptomatic third degree anal sphincter injury. There was limited cross-over between groups: of the 112 women randomized to the vaginal delivery group, 17 (15.6%) had a caesarean section for obstetric indications. For those randomized to the planned cesarean section, 18 (16.58%) delivered vaginally. One fifth of the randomized women did not complete the post-partum follow-up, but their characteristics did not differ between the two study groups. In this RCT, planned cesarean section in the second delivery was unequivocally not protective against anal incontinence at 8 months post-partum, with low rates of symptoms in both groups (Vaizey score 1/24 vs. 1/24 p=0.34). As rates of incontinence were lower than expected, the trial may have been underpowered for a clinically relevant difference between groups. In an unplanned analysis, there was however, an interaction between baseline Vaizey score, and worsening symptoms after vaginal delivery, with significantly worse symptoms after vaginal delivery for women with pre-existing mild symptoms.The authors rightly suggest that the findings are useful when counseling women about risks and benefits of caesarean at their second delivery. These results do not support advising systematic cesarean after asymptomatic third degree obstetric anal sphincter injury. The medicalization of pregnancy associated with planned caesarean is undesirable from both individual and societal perspectives, and cesarean delivery is associated with a number of health risks when compared to vaginal delivery (NICE Clinical Guideline CG132, https://www.nice.org.uk/guidance/cg132/). Important questions remain for future work whether subsequent cesarean section may be useful in the long term, among women with mildly symptomatic anal incontinence, or for women with asymptomatic fourth degree obstetric anal sphincter injury.Disclosure of interests: Tähtinen declares honoraria from Olympus. Cartwright declares no conflicts of interest. Completed disclosure of interest forms are available to view online as supporting information.
Epidemiologic studies performed in the Melbourne Sexual Health Center over several years have explored and emphasized the role of sexual transmission in the pathogenesis of sporadic bacterial vaginosis (BV) as well as recurrent BV (Fethers KA., et al. Infect. Dis. 2008; 47: 1426-1435). Some of the most definitive studies documenting details of heterosexual sexual transmission followed. There can be little doubt as to the causal role of sexual transmission in BV particularly with regard to the initial episode (Cherpes, TL., et al. Sex. Transm. Dis 2008; 35: 78-83). The present study adds solid molecular data to their previous epidemiologic data that recurrent BV is more likely to occur in a heterosexual woman with a single regular male partner (Ratten L., et al BJOG 2020 xxxx): Moreover, the risk is mitigated by use of an oral contraceptive and barrier contraceptives. Specifically, Ratten et al conclude that sex is associated with persistence of non-optimal, BV-associated vaginal dysbiosis following appropriate antimicrobial treatment for BV in a cohort followed prospectively, likely the result of sexual transmission from a regular partner. The key term used in the title of the study is persistence, which implies that the non-optimal vaginal microbiota fails to resolve, as opposed to future reintroduction from the same guilty partner. Persistence in this context, unfortunately, also indirectly suggests that inadequate antimicrobial treatment is currently prescribed to women, perhaps sufficient to relieve symptoms and meet diagnostic criteria of satisfactory response, but insufficient to eradicate BV pathogens. The author emphasizes needed improvement in the, so far, futile male partner therapy to prevent female reinfection, a goal that has repeatedly eluded experts to date.The unanswered question facing patients and clinicians alike is the role of sexual reinfection as opposed to vaginal relapse in the causation and likelihood of BV recurrence. The tone of the article would indicate that reinfection is the more likely causal mechanism of BV recurrence, by emphasizing “persistence” and outweighing the role of unexplained relapse. In dealing with a symptomatic patient suffering from an episode of recurrent BV, it is currently not possible to differentiate relapse from reinfection unless the patient declares herself to be celibate, ergo relapse is the cause of recurrence. The clinical picture is identical as are Amsel or Nugent criteria. Unfortunately, molecular microbiome studies have not revealed significant differences between sequential episodes regardless of causation. We lack a “unique fingerprint” to differentiate cause or nature of the recurrent episode. Even with reinfection, sexual or otherwise, details of pathogenesis are still lacking. We know too that coitus can elicit symptoms of BV (post coital malodor) even with use of a condom. The role of receptive oral-vulvovaginal sex is also undetermined, as is the role of penile – anorectal penetration although the latter was found to be minimal in the latest study by Ratten L., et al. (BJOG 2020 xxxx): Moreover, not all longitudinal studies have revealed that heterosexual sex is a major factor in recurrence (Sobel J.D., et al. Infect. Drug Resist. 2019: 12; 2297-2307).The role of sex and reinfection in causation of RBV will depend significantly upon the population studied, including biologic and behavioral differences. Determination of causation of BV recurrence in different patient populations should be personalized and acknowledged as we admit our current limitations. Will more effective male treatment help reduce BV recurrence? Hopefully but still unknown. Determining all the causes of vaginal microbiota persistence, including the role of biofilm, remains a challenge.No disclosures: A completed disclosure of interest form is available to view online as supporting information.
Having lived through the havoc of COVID-19 in a hospital situated in one of the hardest hit zip codes in the United States, the thought that another wave could loom in the fall is bracing. Obstetricians at our institution have cared for well over 200 COVID-19-infected pregnant women, and are acutely aware of the herculean effort it took to reorganize the service to accommodate the needs of women infected with this new pathogen.1 Many institutions, including ours, modified the frequency of prenatal visits, among other measures, to minimize in-person contacts, in an effort to reduce the likelihood of viral spread. However, it is those changes, along with our prior experience of treating women unimmunized against influenza that leads to our concern that a singular focus on COVID-19 could leave pregnant women at risk from a more familiar threat.While COVID-19 is a threat to the health of individuals and society, its effect on pregnancy is less clear. Thus far, few COVID-19-infected pregnant women have required ICU care, and to date three maternal deaths has been reported in the United States.2-4 The toll of influenza in pregnancy is more clearly documented and is more severe.5Now that the first wave is ebbing in New York, we are seeing fewer and fewer cases but still diagnose about 15 infections per week in our hospital. That pattern is the converse of what is being seen in large swaths of the country. Despite the higher prevalence seen earlier in the epidemic in New York, and the fact that many of those women needed respiratory support, only two women in our hospital required admission to the intensive care unit (ICU), and only one needed ventilator support. Mercifully, none died. During the preceding influenza season, whose end overlapped with the start of the COVID-19 pandemic, we treated six women with influenza who required admission to the ICU, only one of whom had been vaccinated against influenza. As opposed to our COVID-19 cases (putting aside the more rigorous application of social distancing), there were clearly missed opportunities to have prevented some of the morbid events caused by influenza.Admittedly, the higher admission rate to the ICU may be misleading. It is certainly possible that criteria for admission to ICUs, like almost all other aspects of care, evolved during the COVID-19 crisis. There was such a rapid and dramatic increase in the need for ICU beds in our hospital (from a baseline of 40 mid-March, 2020 to a peak of 140 mid-April; 2020, internal data) that more stringent criteria for admission may have been applied and some of our COVID-19 patients that were cared for on the wards, may have been cared for in an ICU in less harrowing times. But even given that possibility, the fact that a similar number of women were extremely ill with influenza raises grave concerns going forward.In the first instance, co-infection with COVID-19 and influenza, as well as other viruses, has been reported.6 Co-infection events will make diagnosis of either entity more difficult, and could potentially increase morbidity. Thus, both because of the risks of co-infection, and the known risks of influenza in pregnancy, providers can’t afford to take their “eye off the ball,” and become less vigilant about vaccinating patients, even if some of the new protocols for fewer visits or telehealth visits remain in place. With fewer visits comes the risk of missing both the vaccination “window” and the opportunity to incorporate vaccination as an essential component of health maintenance. In addition, obstetricians’ performance as vaccinators has been less than ideal as only approximately half of pregnant women get influenza vaccines.7In addition to vaccination, obstetricians must remain vigilant in order to prevent progression of disease among those who get infected. Oseltamivir provides the opportunity for secondary prevention.8 It has been shown to reduce maternal ICU admission and mortality.9 Yet, as with vaccination, even before the COVID-19 epidemic, it was underutilized.10Beyond committing to better use of medical interventions for influenza, obstetricians have to assure that just because they have lived through COVID-19, and the world’s attention remains fixed on COVID-19, they don’t become so COVID-19-focused, that they fail to include influenza in the differential diagnosis of women reporting respiratory symptoms in the fall. Every fever and ache will not be COVID-19. If we delay consideration of the diagnosis of influenza, we will lose the opportunity to use Oseltamivir before the window of eligibility closes. In the post-pandemic world, it will be hard to avoid cognitive biases, such as the availability heuristic (a strategy for making judgments about likelihood of occurrence based on the salience of the information) and confirmation bias (the tendency to gather evidence that confirms preexisting expectations, typically by emphasizing or pursuing supporting evidence while dismissing or failing to seek contradictory evidence). These can result in physicians being hammers and every respiratory symptom, a COVID-19 nail; especially when rapid COVID-19 tests are not uniformly available and don’t yet have uniformly high quality. This is the reverse of one of the most cited examples of the availability heuristic, “In influenza season, it is tempting to consider all patients with fever and myalgias as having influenza.”11 An enhanced situational awareness, i.e., recognizing the influence of recent diagnoses on your diagnostic proclivities, will become an ever more crucial antidote to the hard earned reflex response to fevers and aches that developed during the first wave of COVID-19.We know from history that influenza recurs both in epidemic and pandemic forms, and that an initial wave can be a “herald wave” for the following one.12 Hence, it is our responsibility not to let the current COVID pandemic prevent us from properly dealing with the possibility of overlapping epidemics (seasonal influenza and COVID) in the fall. Vaccination, rapid recourse to antivirals (e.g., Oseltamivir), and community mitigation measures will be more important than ever. COVID-19 can kill, but so can influenza, and if we do our jobs, we can reduce that toll.