Endometriosis is often described as a chronic condition. Surgical or medical treatment approaches do not cure it, and recurrence of the disease or its symptoms is common. Medical treatment is usually used to achieve symptomatic control whilst surgery aims to eliminate the visible lesions. However, recurrence is frequently seen even after very radical surgery.Endometriomas are frequently used for diagnosis and as a marker of recurrence due their easy recognition on imaging. In this issue of BJOG, Wattanayingcharoenchai et al (BJOG 2020 xxxx) present their systematic review and network metaanalysis (NMA) on the efficacy of postoperative medical therapies in reducing endometrioma recurrence with some mixed messages. They conclude that evidence from randomised controlled trials (RCTs) do not support the use of postoperative hormonal therapies, whereas data from cohort studies indicate a significant protective effect of levonorgestrel intrauterine system (LNG-IUS) followed by dienogest, gonadotrophin releasing hormone agonists (GnRHa) + LNG-IUS, continuous and cyclical oral contraceptives (OC). The most effective postoperative therapy (although non-significant) was GnRHa+LNG-IUS, followed by continuous OC and GnRHa based on RCTs.Direct meta-analysis of RCTs in the Wattanayingcharoenchai et al. article indicate an approximately 40-50% reduction with OCs but this remained statistically non-significant. This finding is in contrast to an earlier meta-analysis (Vercellini et al. Acta Obstet Gynecol Scand. 2013;92:8-16) which concluded that the postoperative OC use dramatically reduced the risk of endometrioma recurrence and international guidelines that recommend use of hormonal contraceptives for the secondary prevention of endometrioma (Dunselman et al. Hum Reprod. 2014;29:400-12). So what are we to believe and what should we advise women affected by endometriosis to do?There is a wide variation in the design of studies on which metaanalyses and the current NMA are based on in terms of inclusion criteria, duration of treatment and definition of recurrence. Some studies allocate the participants on the basis of their disease stage without taking the preoperative cyst size and bilaterality into account. The definition of a ‘recurrent cyst’ varies from ‘no definition’ to endometrioma of > 1 cm or >3 cm. These introduce significant heterogeneity which potentially compromise the validity of any meta-analysis. Furthermore, there is also a conceptual difference between using medical treatment (e.g. GnRHa) for 3-6 months postoperatively and continuing with therapy (e.g. hormonal contraceptives) in the long term and assessing the recurrence rates at 1-5 years. In fact the ESHRE guideline (Dunselman et al.) proposed distinguishing postoperative adjunctive treatment of < 6 months that aims to improve the outcome of surgery and longer treatments with the intention to reduce recurrences (secondary prevention). The former may have a significant side effect profile whereas the latter has a good safety record.It is very plausible that suppression of ovulation and reducing/eliminating menstrual flow in the long term would reduce recurrences. The current literature is too heterogeneous and fragmented to confirm or refute this. Properly designed large scale studies with the required power are still required. The Pre-Empt trial which is currently ongoing in United Kingdom may give some of the answers.Disclosure of interest: None. A completed disclosure of interest form is available to view online as supporting information.
Sir, We read with interests the article by Kate F Walker and colleagues, entitled ”Maternal transmission of SARS-COV-2 to the neonate, and possible routes for such transmission: A systematic review and critical analysis”. In the article, the authors systematically analyzed the mode of delivery on the infection rates of COVID-19 in the newborn. Despite the limitations, especially the retrospective nature of studies examined, this study provided important information about the selection of mode of delivery of women with COVID-19. It suggests that neonatal infection rates are not different after Caesarean birth or vaginal delivery. However, the severity of the COVID-19 infection of the mothers was not considered. Clinically, pregnant women with the more severe COVID-19 infection appear to prefer delivery by Caesarean delivery rather than vaginal birth. Therefore, it is possible that any beneficial effects of Caesarean birth in reducing transmission of COVID-19 might not be apparent because the severity of COVID-19 infection was greater in these women. This selective bias would weaken the conclusions of current studies. We feel that prospective evaluation the safety of mode of delivery with COVID-19 is required.Rui-hong Xue11Department of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
We are all likely to need a blood test, a biopsy or wind up on the wrong end of an endoscope. We know that the experience is not going to be pleasant. Many of us will revert to techniques to divert attention away from painful stimuli, such as counting forwards or backwards in our heads, deep breathing, imagining tranquil places or listening to music. But the paper published in this issue of BJOG by (Neo D et al, BJOG 2020; xxxx) shows us how we can distract patients in a more sophisticated way, using virtual reality (VR) technology. The procedure the research groups chose to investigate was outpatient hysteroscopy.Outpatient hysteroscopy is a key part of contemporary gynaecological practice. The procedure is acceptable to the vast majority of women, but most will experience some pain and, in a small proportion of women, this can be severe (Smith P, et al, BJOG 2019;126:891-899). Thus, outpatient hysteroscopy, being common and potentially painful, is a good health technology to evaluate the impact of VR technology on patient experienceDeo N et al, conducted a randomised trial of 40 women undergoing outpatient hysteroscopy for a variety of indications and simple therapeutic procedures were allowed such as biopsy, polypectomy and insertion of a Mirena® device. Women were allocated to standard care or “immersive and interactive video content using a portable, standalone VR headset”. The latter delivered a “guided relaxation experience” which included viewing an 8-minute, narrated video depicting “a calming rainforest and lake setting with animated wildlife, which could be explored by using the “head-tracker”.The preliminary results are impressive. Reduction in peri-procedural pain was statistically significant but more importantly the effect size of a 2cm (20%) difference on a 10cm visual analogue scale must be clinically significant. Reduction in anxiety scores were of a similar magnitude. However, the average hysteroscopy procedure duration was less than 4 minutes, which begs the question, is the cost, time and hassle of setting up and using VR technology worth it? Moreover, 16% of eligible women did not want to use the VR technology because of prior adverse experiences, anxiety or state a preference to see the procedure or use their own distraction media.No-one is going to change clinical practice on a sample of 40, but many practitioners will be energised to conduct larger scale trials to confirm these provisional results and to analyse more deeply the impact of immersive VR technology on reducing pain and anxiety associated with outpatient hysteroscopy. Future work should look at the type of VR technology, the context where it is deployed for what kind of procedure. The optimal VR programme may vary according to patient characteristics, the type of surgery and its duration. VR technology should be tested in more painful gynaecological interventions such as endometrial ablation, cervical biopsy and transvaginal egg collection. Moreover, the prospective benefit of VR need not be restricted to gynaecological practice but should be evaluated in a whole host of ambulatory procedures involving conscious patients.No disclosures: A completed disclosure of interest form is available to view online as supporting information.
Global estimates for 2017 indicated that there were 295,000 maternal deaths, 35 per cent lower than in 2000 with a decline in global maternal mortality ratio from 342 to 211 deaths per 100,000 live births (World Health Organization (WHO) 2019). Maternal hemorrhage is the leading direct cause of maternal death worldwide, representing 27% (20-36) of maternal deaths ( Say L, et al. Lancet 2014).Multiple large retrospective population cohorts have identified risk factors invariably associated with maternal hemorrhage including mode of delivery, prolonged labor, chorioamnionitis, and twins among others (Briley A, et al. BJOG 2014). Factors such as maternal BMI, race or ethnicity, pregnancy induced hypertension, and maternal age have not been consistently associated with increased PPH and require more research, especially given the relationship between maternal obesity, gestational diabetes, pregnancy induced hypertension and PPH.Over 80% of cases of primary PPH are preventable and are due to uterine atony. Active management of the third stage is the gold standard for prevention of PPH. Among women at low risk it is not clear whether active management provides benefit, as with women at mixed risk or at high risk for PPH (RR 0.34, 0.14-0.87) (Begley CM, et.al. Cochrane 2019). The WHO has published evidence-based recommendations for management of PPH and have included use of an effective uterotonic with oxytocin being the preferred agent with alternatives used in specific circumstances when oxytocin is not available (Who, 2018). Most recently, use of tranexamic acid has been introduced for prevention and treatment of PPH with a potential to reduce risk of severe PPH by 50% and maternal death by 20%. (Shakir H, et. al. Lancet 2017). These evidence based interventions have been endorsed by professional organizations and the WHO, and have contributed to a progressive decrease in maternal mortality secondary to hemorrhage.Assessment of risk for hemorrhage incorporates risk factors and appropriate protocols according to risk, implementing preventive measures on an individualized basis. It has been demonstrated that successful implementation requires more than identifying risk factors and their interdependence. Attention to organizational context, involvement of entire health care team, and increased recognition of the role of organizational leadership have been identified as basic components (Main EK, et al. AJOG 2017).In this issue of BJOG, Neary et. al. (BJOG 2020 xxxx) address the important aspect of quality and clinical applicability of risk assessment tools using a structured review that included systematic assessment for bias, sample size and both internal and external validation following a standardized methodology established by PRISMA and CHARMS. The authors concluded that current risk assessment protocols have deficiencies related to general obstetrical applicability and lack of external validation. They recommend development of more broadly applicable and appropriately validated risk assessment protocols that would applicable to the general obstetrical population.Evidenced based risk assessment and corresponding protocols during the antepartum, intrapartum and most importantly immediately after delivery, has the potential of contributing to the prevention of over 80% of maternal deaths attributable to maternal hemorrhage.No disclosures: A completed disclosure of interest form is available to view online as supporting information.
Sir ,We read with great interest the study by Zhou et al.1, where the authors demonstrated a significant association between preconception paternal smoking and birth defects in the offspring. The study is timely given the increasing recognition of the role that paternal factors play in pregnancy outcomes. The authors must be congratulated on performing a large scale, nationwide study, in which a potential link between preconception paternal smoking and birth defects in offspring was made.A salient point discussed by Zhou and colleagues is the difficulty in estimating the effect of paternal smoking as an independent variable on the risk of birth defects due to a myriad of confounding factors. Although the authors had adequately adjusted for maternal biological, environmental and behavioural factors, as well as paternal alcohol consumption, it may be prudent to note that paternal age could be a potentially significant confounder in this relationship.Advanced paternal age has shown robust links with increases in sperm DNA fragmentation.2 DNA damage is attributed to environmental, hormonal and degenerative changes.2Over time, multiple cycles of mitotic replications generate greater stress on the DNA repair mechanisms.2 The failure to control the DNA repair mechanisms invariably amounts to ejaculated spermatozoa containing a higher proportion of abnormal paternal DNA.2 In the same vein, children born to fathers of advanced age are at a slightly increased risk of birth defects including cardiac, respiratory, gastrointestinal tract and musculoskeletal abnormalities.3 It has been speculated that mutations accumulate over repeated spermatogenesis, subsequently increasing the number of birth defects in the offspring.3 At the opposite end of the age spectrum, young paternal age has also been associated with a slight increased risk of selected birth defects.3At large, prenatal smoke exposure has unfavourable effects on pregnancies. Effects of maternal smoking has been comprehensively studied and is associated with fetal and developmental conditions. Harmful substances in tobacco smoke such as nicotine, carbon monoxide and polycyclic aromatic hydrocarbons are able to cross the placenta and negatively affect the fetal development.4 On the other hand, the extent of paternal smoking has not been well-established. Exposure to cigarette smoke has been found to affect sperm parameters, as well as increase sperm chromatin structural abnormalities and DNA damage.5 Infant low birth weight, increased obesity risk in childhood and high blood pressure have been identified as potential complications of paternal smoking.4 This study provides new evidence that birth defects are also complications of paternal smoking.In conclusion, Zhou et al. have accomplished a tremendous job of investigating the effects of paternal smoking on birth defects. The current study has laid the groundwork for future research to be built upon and to elucidate the true effects of paternal smoking during pregnancy. As exposure to first or second-hand smoke poses a major risk to pregnancies, it might be worthwhile to recommend smoking cessation in both parents during preconception counselling.Jania J. Y. Wu1, Kyla Ng Yin2, Keng Siang Lee3, John J. Y. Zhang11Yong Loo Lin School of Medicine, National University of Singapore, Singapore2Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK3Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK
Effective Cervical screening involves a complex sequence of interactions between women, clinical staff and systems. Even in well organised screening programmes, achieving high population coverage is challenging. The transition to using Human Papilloma Virus (HPV) testing as the primary screening modality, rather than cytology, has introduced the possibility of using a self-collected sample for the primary HPV test. This has been shown to be a reliable method of detecting CIN2+ (Polman et al, Lancet Oncology 2019;20(2):229-38).Regardless of the way the sample is collected, the low specificity of a positive HPV test means that positive results must be triaged. In all cases where self-sampling has been integrated into a cervical screening programme to date, this triage is by cytology on a subsequent, clinician taken sample. Other molecular tests which can be performed on the original sample may in the future be an alternative, but are not yet fully evaluated.It has generally been assumed that a self-collected sample would not be suitable for cytology because the cervix is unlikely to be thoroughly (if at all) sampled.However, the authors have shown that using a well-established self-sampling device, 95.8% samples had at least 5000 cells, the usual threshold for adequacy for cytology. (ThinPrep LBC method). Results were highly specific, and in fact the positive predictive value (PPV) for high grade disease was higher on the self-collected specimens than on the subsequent professionally taken samples (Loopik et al. BJOG 2020 xxxx).As expected, the sensitivity of the test was lower than for a professionally taken sample, but it still detected 29.4 % of CIN2+. In this study, an impressive 91.9% of women returned for their reflex cytology test. This is higher than in other studies, possibly because the study was not focussed on women who have previously not responded to invitation.It is likely that a significant proportion of women needing treatment could be reliably identified by self-sampling alone by this method.It is worth noting that despite implementation in several organised screening programmes, self-sampling tests for HPV have yet to achieve regulatory approval, and the process for doing so for cytology from self-collected samples is likely to require studies with more extended monitoring of clinical outcomes.Self-sampling is not yet widely implemented internationally and the pathways can be challenging. There is a concern about how to address loss to follow up, design of multistep pathways for management, and potential delays in diagnosis. A pathway which could reliably prioritise women for referral for immediate colposcopy, with a high PPV for CIN2+, without requiring a face to face clinical interaction would be extremely valuable. This is potentially even more topical in the post COVID-19 world where there are new challenges in risks of consultations and in capacity of health care delivery.No disclosures: A completed disclosure of interest form is available to view online as supporting information.
Sir, We would like to thank Sharma and colleagues for their interest in our recent study evaluating the effectiveness and safety of surgical interventions for Bartholin’s cyst or abscess.1Their response highlights the unique opportunity offered by randomised trials, and their syntheses into meta‐analyses, to assess patient reported outcomes. We would strongly encourage researchers to select, collect and report patient reported outcomes in future research evaluating interventions for Bartholin’s cyst or abscess.2The primary outcome should be the outcome of greatest therapeutic importance to the study’s prospective hypothesis. There is currently no consensus regarding the selection of outcomes and methods of definition or measurement for randomized trials evaluating interventions for Bartholin’s cyst or abscess.3 In the absence of a standardized approach, researchers have made arbitrary decisions when choosing among several important outcomes.4 It would be useful for healthcare professionals, researchers, and women with lived experience of Bartholin’s cyst or abscess to engage in a formal consensus development process to agree appropriate primary and secondary outcomes.3We agree the use of adjuvant antibiotics is an important consideration. They were not reported by any of the included trials.5We have no experience of marsupialization performed under local anaesthetic. In our opinion, this approach would need to be evaluated within a research setting. The recent COVID-19 pandemic would provide additional impetus to undertake this much needed research.James M. N. Duffy 1,2, Emma Kirk 3, BJG Illingworth 4, K Stocking 5,Marian Showell 61 Institute for Women’s Health, University College London, London, United Kingdom.2 King’s Fertility, Fetal Medicine Research Foundation, London, United Kingdom.3 Department of Obstetrics and Gynaecology, Royal Free London NHS Trust, London, United Kingdom.4 North West Anglia NHS Foundation Trust, Peterborough City Hospital, Peterborough, UK5 Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK6 Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand.
Dear EditorI read with interest the paper by Xindong Qin et al. “Acupuncture for Recurrent Urinary Tract Infection in Women: A Systematic Review and Meta-Analysis1 in which the possible mechanisms for acupuncture are discussed. This article refers to one of my studies,2 but one of the study’s main findings has been omitted. We found a correlation between fewer urinary tract infections and a reduction in volume of residual urine in the women treated with acupuncture. This change in residual urine did not occur in the control group who were not treated with acupuncture. Residual urine or post-voided volume was measured by a bladder scan, in a hospital setting, and by a nurse who was blinded to participants group allocation. What is an empty Bladder? A post-voided volume above 30 ml, in otherwise healthy women, has been regarded as one of many potential risk factors for recurrent urinary tract infection.3Interestingly all women in our study had at baseline more than 30 ml of residual urine.2 After 6 months control this was reduced from 35,4 ml to 18.2 ml (P ≤ 0 .01) in the acupuncture group while no change was observed in the control group (35.5 vs 38.8ml). Furthermore, residual urine has been recognized as one of several potential risk factors for recurrent urinary tract infections in children 4 and in healthy postmenopausal women.5 It is therefore important that post-voided volumes are included in future studies on acupuncture as a prophylactic treatment for recurrent urinary tract infections. Finally, a question to the authors,1 on page 6, you write: “None of the studies reported the secondary outcomes of urinary bacteria culture, WBCs of urine dipstick, kidney function, markers of kidney damage, health-related quality of life or healthcare costs.” However, our study2 used a dipstick (Uricult) and we presented the number of infections with or without bacteriuria.Sincerely,Terje AlrækSchool of Health Sciences / NAFKAM, Department of Community Medicine, Kristiania University College / Faculty of Health Science, UiT The Arctic University of Norway 0107 Oslo, Norway / 9037 Tromsø, NorwayReferencesQin X, Coyle ME, Yang L, Liang J, Wang K, Guo X, Zhang AL, Mao W, Lu C, Xue CC, Liu X. Acupuncture for recurrent urinary tract infection in women: a systematic review and meta-analysis. BJOG 2020; https://doi-org.pva.uib.no/10.1111/1471-0528.16315Alraek T, Soedal LI, Fagerheim SU, Digranes A, Baerheim A. Acupuncture treatment in the prevention of uncomplicated recurrent lower urinary tract infections in adult women. Am J Public Health 2002;92:1609–11Haylen BT. The empty Bladder. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):237-9. doi: 10.1007/s00192-006-0111-0Hoebeke P, Van Laecke E, Van Camp C, Raes A, Van De Walle J. One thousand video-urodynamic studies in children with non-neurogenic bladder sphincter dysfunction. BJU International (2001), 87, 575–580Stamm WE, Raz R. Factors contributing to susceptibility of postmenopausal women to recurrent urinary tract infections. Clin Infect Dis. 1999 Apr;28(4):723-5. doi: 10.1086/515209.
In this issue of BJOG, Mendoza and colleagues report in an observational study the occurrence of a preeclampsia-like syndrome in six out of eight pregnant patients with novel coronavirus disease (COVID-19) who were admitted to the Intensive Care Unit (ICU) with severe pneumonia (Mendoza M, et al. BJOG 2020). There were no symptoms of preeclampsia amongst the 34 pregnant women who had mild forms of COVID-19. Importantly, the authors recorded not only routine laboratory test results, but also measured biophysical and biochemical markers that are typically altered in women with preeclampsia (uterine artery pulsatility index on Doppler ultrasound, serum soluble fms-like tyrosine kinase-1 [sFLT-1] and placental growth factor [PlGF]). Such markers were normal in five of the six cases, in whom the symptoms of preeclampsia resolved after improvement of the maternal clinical situation.The intriguingly high cumulative incidence of preeclampsia symptoms in women with severe coronavirus disease needs to be interpreted with caution due to the observational nature of the study, the small number of pregnant women with severe infection and the possible role of confounding factors. The normal biomarker results in most cases, nevertheless, suggest that severe coronavirus disease can lead to symptoms that mimic those of preeclampsia in the absence of defective placentation, which is further corroborated by the resolution of the symptoms without the delivery of the placenta when overall clinical improvement occurs. It is plausible that such manifestations are the result of widespread inflammation and endothelial damage, in a process that has been denominated “cytokine storm”, responsible for many of the symptoms of the coronavirus-related organ injury (Mehta P, et al. Lancet 2020;395:1033-34) This mechanism includes activation of inflammation pathways that convert arachidonic acid to prostaglandins, thromboxane and eicosanoids, ultimately provoking significant cytokine release. The cascade of events, however, does not appear to influence the levels of specific preeclampsia angiogenic and anti-angiogenic markers such as sFLT-1 and PlGF.A normal sFLT-1: PlGF ratio in women with clinically suspected preeclampsia can be reliably used predict the short-term absence of disease (Zeisler H, et al. N Engl J Med 2016;374:13-22). Although the definition of preeclampsia has changed over the last 20 years to incorporate less specific clinical features of end-organ damage, biomarkers will likely become part of the disease definition in the years to come or, at least, a valuable tool to select subgroups of women at higher risk of preeclampsia-related morbidity and mortality who require closer monitoring or immediate delivery.While larger cohorts derived from national datasets or international registries of coronavirus disease in pregnancy will be essential to confirm or refute this association, the preliminary data published in this study indicate that delivery during severe coronavirus disease should not be based on preeclampsia symptoms alone, particularly at early gestational ages, and that the use of ultrasound and serum biomarkers such as the sFLT-1: PlGF ratio might help to guide clinical management by distinguishing hypertension and endothelial dysfunction caused by COVID-19-related inflammation from true preeclampsia.No disclosures: A completed disclosure of interest form is available to view online as supporting information.
Dear Editor,We read with great interest, the article titled “Evaluation of treatments for Bartholin’s cyst or abscess: A systematic review” by authors BJG Illingworth K Stocking M Showell E Kirk JMN Duffy Published in BJOG volume 127, issue 6, May 2020. The article was particularly relevant owing to the fact that Bartholin’s Abscess is a common gynaecological presentation which we encounter regularly in clinical practice.Whilst this article provided some insight into the various techniques for managing Bartholin’s Abscess around the world , there were a few points that we would like to raise. It was not unexpected that the meta-analysis finally concluded that no single technique was superior to the others. This may very well have been due to the different criteria used by these studies to assess the effectiveness of the procedure. Since the failure or success of any technique is largely based on the effect on the quality of life and perception of the outcome by the patient, it may have been more prudent to compare different surgical interventions in terms of patient acceptance, overall satisfaction and long term outcome. Also this analysis compiled data from countries where health services are provided by the private and /or the government sector where the financial incentives for performing procedures vary widely  . The article does not elaborate on the proportion of patients who had received pharmacological treatment for varying durations prior to these surgical interventions, which undoubtedly may have influenced the outcome. The analysis also does not include any study where marsupialization was performed under local anaesthetic which may be equally if not more effective than the word catheter at equal cost. In the light of current pandemic situation that the whole world is facing, expertise into minimally more invasive gynaecological procedures to be performed in office setting would also be a key point of consideration. We look forward to the authors comments on these factors.Piyushi Sharma,1 Thangamma Katimada-Annaiah,1 Montasser Mahran,1 Dilip Patil,1 Elvyna Lim,1 Joseph Nattey,1 Tarley Davies1Bedford Hospital NHS TrustReferences1. Illingworth BJG, Stocking K, Showell M, Kirk E, Duffy JMN. Evaluation of treatments for Batholin’s Cyst or abscess: A systematic Review. BJOG 2020;127:671-678
Dear Editor,We would like to comment on the systematic review by Li et al.(1)The use of steroid hormones in the first trimester is a serious issue as organogenesis takes place at this time and therefore there is the possibility of harm from not only congenital anomalies, but also long-term, and even inter-generational effects. Anyone investigating the use of steroid hormones in the first trimester should remember the diethylstilbestrol legacy of devastating harm. Oestrogen (C18H24O2) and diethylstilbestrol (C18H20O2) have similar molecular composition, but their effects are poles apart. In this review, the authors have combined progesterone with progestogens; however they are not the same, in the same way that oestrogen and diethylstilbestrol are not the same. Vaginal micronized progesterone, which we used in our large and high-quality trials (the PROMISE (2) and PRISM (3) trials), has identical molecular structure to natural progesterone, but the other drugs included in this review do not (Table 1). We chose to study vaginal micronized progesterone, as it is identical in structure to natural progesterone, and the available evidence and expert opinion suggested that this is least likely to cause harm. It is important to note that there is evidence of potential harm from dydrogesterone, particularly congenital heart disease.(4)The authors make a bold statement in the abstract about the effects of dydrogesterone on live birth rate. However, they don’t fully address the weaknesses in the evidence. Therefore, we wish to highlight the significant deficiencies in the two trials that contributed live birth data that led to the assertion of beneficial effects from dydrogesterone. Both studies were single centre, open-label studies without placebo control. El-Zibdeh et al did not randomise participants, but instead allocated patients to dydrogesterone on Saturdays, Mondays and Wednesdays, and to no treatment on Sundays, Tuesdays and Thursdays. The trial by Pandian RU was not just a single-centre, but also a single-author study, with insufficient details of the methods to assess its quality. Thus, the effectiveness evidence from these trials cannot be considered reliable.Approximately 80% (4038 of 5056) of the data used in this systematic review come from our PRISM trial.(3) The PRISM trial is a prospectively-registered, randomised, placebo-controlled, multi-centre trial conducted to the highest standards in the UK. The trial found a 3% increase in live birth rate, but with borderline statistical significance (RR, 1.03; 95% CI, 1.00 to 1.07; P=0.08). A pre-specified subgroup analysis in women with the dual risk factors of current pregnancy bleeding and one or more previous miscarriages found a 5% increase in live birth rate (RR, 1.09; 95% CI, 1.03-1.15; P=0.003). In those with three or more previous miscarriages, a 15% increase in live birth rate was observed (RR, 1.28; 95% CI, 1.08 to 1.51; P=0.004).(3, 5) No short-term safety concerns were identified. Based on these data, our recommendation is to consider vaginal micronized progesterone for women with early pregnancy bleeding and one or more previous miscarriages. As for the role of dydrogesterone, we need not only high-quality, randomised trial evidence of its effects but also credible evidence of its safety. As dydrogesterone is a synthetic progesterone-like drug, i.e. a progestogen but not progesterone, the burden of proof to demonstrate short- and long-term safety rests on those promoting this drug.
Dear EditorBirth Trauma organisations advocate on behalf of women and babies who have experienced adverse outcomes and naturally they will take a risk-averse perspective on birth-related care. The latest version of the Assisted Vaginal Birth (AVB) RCOG Guideline (previously called Operative Vaginal Delivery) has focussed specifically on revisions designed to minimise the risk of traumatic injuries for the mother and baby.1 The landmark Montgomery ruling that raised the bar on the standard required for informed consent has been embraced and endorsed within the guideline. 2 It is disappointing to read that Hull et al have concluded that “Montgomery is missing from RCOG’s Assisted Vaginal Birth guideline”.3Hull et al have acknowledged the important counselling advice that has been recommended – antenatal discussion about AVB when planning birth in the third trimester (especially for first-time mothers), review of birth preferences when conducting routine labour ward rounds, and in depth counselling, where circumstances allow, if complications arise during the course of labour particularly during the second stage. However, the guideline apparently falls short of the Montgomery ruling in that we have not recommended “planned caesarean” as an option to prevent assisted vaginal birth.The AVB guideline went through an extensive scoping process. The agreed scope was to address all key questions that arise in relation to labouring women who may require obstetric assistance in the second stage of labour - the assumption being that these women have the intention to labour and deliver vaginally. A guideline addressing maternal request “planned” caesarean section is an entirely different guideline. It is also incorrect to state that the RCOG have provided no direct guidance on this (see Choosing to have a Caesarean section , RCOG Patient Information (2015) based on NICE Clinical Guideline Caesarean Section (2011)).4 The issue of pelvic floor morbidity was included in the literature search and has been discussed in detail.The Montgomery ruling related to a woman with diabetes in pregnancy and a large for gestational age fetus who experienced shoulder dystocia resulting in her baby developing cerebral palsy. The importance of outlining, in advance, the birth options for this woman is clear, given the specific known risks associated with labour in her circumstances. Hull et al suggest on the same basis that all women should be advised that a planned caesarean section is an option to prevent assisted vaginal birth. If taken one step further the Montgomery ruling could be cited to support the argument that all women should be advised that the best way to avoid pregnancy-related complications is to avoid getting pregnant. Common sense would infer that this was not the intention of the Montgomery ruling.Where this RCOG guideline is likely to be consistent with Birth Trauma organisations is in the recommendations on careful assessment, supervision and decision-making; clear communication and transparent consent procedures; and an overall approach that places safety as the first priority when deciding when and when not to attempt a vacuum or forceps assisted delivery, and when to discontinue any such attempt. It is hoped that all relevant health professionals will review and implement the evidence-based, peer-reviewed recommendations within this guideline. They are designed to support women in achieving safe and joyful births, even when obstetric assistance is required.Deirdre J Murphy,1 Rachna Bahl,2Bryony Strachan21) Coombe Women & Infants University HospitalCork St, Dublin 8, Republic of Ireland2) St Michael’s Hospital, Bristol
Just weeks following the fifth anniversary of the landmark Montgomery v Lanarkshire Health Board Supreme Court judgment, the Royal College of Obstetricians and Gynaecologists (RCOG) has delivered the fourth edition of its Green-top guideline on forceps and vacuum assisted births1. The irony of this is not lost on those who expected real change following last year’s peer review consultation (19 physicians and 6 maternity care organisations responded, including the first two signatories of this letter). The guideline opens with a fundamental question: Can assisted vaginal birth be avoided? The answers RCOG provides are solely in the context of labour (evidence on continuous support, epidural analgesia, positions adopted, delayed pushing), but a legal interpretation of Montgomery advises birth is “a situation that allows for significant advance planning and accordingly plans must be made.”2 The guideline concurs: women “should be informed about assisted vaginal birth in the antenatal period, especially during their first pregnancy [and] in advance of labour”. Nevertheless, while “lower rates in midwifery-led care settings” is included, ‘lower rates with planned caesarean’ is not, and there is no direct equivalent Green-top for this birth mode. The Montgomery judgment on consent specifically states that doctors are “under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.” It also emphasises that in any pregnancy, the “principal choice is between vaginal delivery and caesarean section.” RCOG may argue that referencing the “alternative choice of a caesarean section late in the second stage of labour” sufficiently addresses these points. However, a Queen’s Counsel who was involved in the Montgomery case reminds doctors that the mother “was not advised that an alternative to vaginal birth (i.e. caesarean section) was an option available to her… and there was an increased risk… should vaginal birth be attempted.”2 He warns, “Where the patient asks a question, it must be answered honestly and fully”, which suggests that planned caesarean birth omission from this Green-top could have serious legal consequences, and there is every chance the Montgomery case could reoccur.Despite aiming “to provide evidence-based recommendations”, RCOG does not include pelvic organ prolapse as an adverse outcome. Instead, it says women who “achieve an assisted vaginal birth rather than have a caesarean birth… are far more likely to have an uncomplicated vaginal birth in subsequent pregnancies”, and that “much of the pelvic floor morbidity reported… may not be causally related to the procedure.” Furthermore, the stated aim of RCOG’s clinical Green-tops is to identify “good practice and desired outcomes”, which will be “used globally.”4 This is relevant because many countries define this as low caesarean birth rates. In the UK, the National Institute for Health and Care Excellence (NICE) does not advocate targets, and recommends support for prophylactic caesarean birth requests.3 Yet decades of promoting vaginal birth rather than informed choice has obstructed autonomy and contributed substantially to rising litigation costs.5The truth is, the NHS simply cannot afford to keep repeating the same communication and consent mistakes, and in our view, this NICE accredited Green-top guideline clearly demonstrates that lessons from Montgomery have still not been learned.Pauline M Hull, Founder, Caesarean BirthKim Thomas, CEO, Birth Trauma OrganisationDr. Elizabeth Skinner, Faculty of Medicine, University of SydneyAmy Dawes, Co-founder and CEO, Australasian Birth Trauma AssociationPenny Christensen, Executive Director, Birth Trauma Canada
Sir,We read with great interest the recent study by Misra et al.evaluating different surgical interventions for the treatment of pain associated with endometriosis.1 We understand the importance of this research to inform our clinical practice and extend our gratitude to the researchers, the women who participated in the study, and the research funder.BJOG: An International Journal of Obstetrics and Gynaecology has been at the forefront of reducing research waste by implementing several important interventions including the requirement to prospectively register randomised trials, implementing the Consolidated Standards of Reporting Trials (CONSORT) statement, and mandating the reporting of core outcome sets.2Reflecting upon this recent study presents an opportunity to consider the impact of implementing such initiatives on selective outcome reporting. The authors prospectively registered their trial (ISRCTN50928834) and reported their pre-specified primary outcome as pelvic pain. This differs from the primary outcome reported in the final publication. A secondary outcome, dyspareunia, reported in the final publication, was not prospectively registered. The CONSORT statement commits researchers to report all prespecified primary and secondary outcomes. When new outcomes are added this should be made clear in the final publication and a comprehensive explanation provided. It would be useful for the authors to clarify the discrepancies between the prospective registry record and the published trial report.Core outcomes aim to address the challenges of poorly selected, collected, and reporting outcomes, including tackling outcome reporting bias.3 We are grateful to the authors for acknowledging the development of a core outcome set for endometriosis research within their study report. The core outcome set for endometriosis has recently been published and was developed using formal consensus methods involving 116 healthcare professionals, 32 researchers, and 206 women with endometriosis from 29 countries.4 The core outcomes include overall pain, improvement in most troublesome symptom, quality of life, adverse events, and patient satisfaction with treatment. It would be useful for the authors to clarify if the core outcomes had been collected as part of the trial and report available data.Over eighty speciality journals, including the Cochrane Gynaecology and Fertility Group, have committed to supporting the development, dissemination, and implementation of the core outcome set for endometriosis. The collaboration who have developed the core outcome set for endometriosis are now assisting with implementation and are systematically examining published endometriosis trials. Where inconsistencies between the trial registry record and the outcomes reported in the published trial report are identified or when the core outcome set has not been fully reported we are writing to the authors seeking clarification. Our progress can be followed at https://twitter.com/EndoOutcomes where we will be posting the prospective registry record, final publication, and response to this letter.