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Listeria monocytogenes is a commonly found organism in processed and prepared food and the disease of listeriosis is associated with a high morbidity and mortality. Compared with the general population, the risk of being diagnosed with listeriosis increases during pregnancy. Listeriosis can lead to miscarriage, spontaneous preterm labour and preterm birth, stillbirth and congenital neonatal infections. We conducted a universal review of listeriosis in pregnancy and in the newborn. The EMBASE, PubMed, Cinahl and Web of Science databases were searched for systematic reviews indexed before 1 December 2020. Any systematic reviews evaluating the prevalence, treatment, diagnosis and effects of listeriosis during pregnancy and up to 4 weeks postnatally were included. Eligibility assessment, data extraction and quality assessment by the Methodological Quality Assessment of Systematic Reviews (AMSTAR-2) were performed in duplicate. We identified 397 citations of which nine systematic reviews comprising 330 studies and 487 patients' reviews were included. Most systematic reviews (seven of nine) were of moderate to high quality. Prevention in pregnant women was based on adherence to strict dietary recommendations, such as reheating leftovers until steamed and avoiding unpasteurised dairy products. Listeriosis infections were likely to occur in the third trimester (66%) rather than in the first trimester (3%) of pregnancy. Symptoms are mostly fever and other flu-like symptoms, such as fatigue. Diagnosis was primarily made by culture of the pathogen. Intravenous amoxicillin or ampicillin were first-line treatment. Listeriosis, a rare but serious infectious disease in pregnancy, can cause devastating consequences for the fetus and newborn. Appropriate preventative treatment should be initiated during early pregnancy to avoid complications. Listeria is commonly found in processed and prepared food. Prevention is the best way to avoid listeriosis during pregnancy.

To develop and validate novel prediction models to personalise the risk of conversion from laparoscopic to open hysterectomy in benign conditions.Retrospective cohort study.English NHS Hospitals between 2011 and 2018.68 752 women undergoing laparoscopic hysterectomy for benign conditions.We developed two multivariable logistic models using readily available clinical information, one for the pre-operative setting and another for operative decision-making using additional surgical information, using 2011-2016 data in five regions (24 806 women). We validated them (a) temporally in the same regions using 2017-2018 data (12 438 women); (b) geographically in the same time-period using data from three different regions (22 024 women); and (c) temporally and geographically using 2017-2018 data in three different regions (9484 women).Conversion from laparoscopic to open hysterectomy.Conversions occurred in 6.8% (1687/24 806) of hysterectomies in the development group, and in 5.5% (681/12 438) in the temporal, 5.9% (1297/22 204) in the geographical and 5.2% (488/9484) in the temporal and geographical validation groups. In the development cohort, the area under the receiver operating characteristic curve values for the pre-operative and operative models were 0.65 and 0.67, respectively. In the validation cohorts the corresponding values were 0.65 and 0.66 (temporal), 0.66 and 0.68 (geographical) and 0.65 and 0.68 (temporal and geographical), respectively. Factors predictive of conversion included age, Asian ethnicity, obesity, fibroids, adenomyosis, endometriosis and adhesions. Adhesions were the most predictive (odds ratio 2.54, 95% confidence interval 2.22-2.90).The models for predicting conversions showed acceptable performance and transferability.Novel tool to personalise the risk of conversion from laparoscopic to open hysterectomy in benign conditions.

Objective: To evaluate the effectiveness of virtual reality as a distraction technique in the management of acute pain and anxiety during outpatient hysteroscopy. Design: Parallel group, prospective randomised controlled trial. Setting: UK University Hospital. Methods: Forty consenting, eligible women were randomised to virtual reality intervention (immersive video content as a distraction method) or standard care during outpatient hysteroscopy from August to October 2018. Main outcome measures: Pain and anxiety outcomes were measured as a numeric rating score (scale 0–10). Results: Compared with standard care, women with virtual reality intervention experienced less average pain (score 6.0 versus 3.7, mean difference 2.3, 95% CI 0.61–3.99, P = 0.009) and anxiety (score 5.45 versus 3.3, mean difference 2.15, 95% CI 0.38–3.92, P = 0.02). Conclusion: Virtual reality was effective in reducing pain and anxiety during outpatient hysteroscopy in a mixed‐methods randomised control trial. Its wide potential role in ambulatory gynaecological procedures needs further evaluation. Tweetable abstract: Virtual reality can be used as a part of a multimodal strategy to reduce acute pain and anxiety in patients undergoing outpatient hysteroscopy.

Summary Objective Women with pre‐eclampsia have elevated circulating levels of soluble fms‐like tyrosine kinase‐1 (sFlt‐1). Statins can reduce sFlt‐1 from cultured cells and improve pregnancy outcome in animals with a pre‐eclampsia‐like syndrome. We investigated the effect of pravastatin on plasma sFlt‐1 levels during pre‐eclampsia. Design Blinded (clinician and participant), proof of principle, placebo‐controlled trial. Setting Fifteen UK maternity units. Population We used a minimisation algorithm to assign 62 women with early‐onset pre‐eclampsia (24+0–31+6 weeks of gestation) to receive pravastatin 40 mg daily (n = 30) or matched placebo (n = 32), from randomisation to childbirth. Primary outcome Difference in mean plasma sFlt‐1 levels over the first 3 days following randomisation. Results The difference in the mean maternal plasma sFlt‐1 levels over the first 3 days after randomisation between the pravastatin (n = 27) and placebo (n = 29) groups was 292 pg/ml (95% CI −1175 to 592; P = 0.5), and over days 1–14 was 48 pg/ml (95% CI −1009 to 913; P = 0.9). Women who received pravastatin had a similar length of pregnancy following randomisation compared with those who received placebo (hazard ratio 0.84; 95% CI 0.50–1.40; P = 0.6). The median time from randomisation to childbirth was 9 days (interquartile range [IQR] 5–14 days) for the pravastatin group and 7 days (IQR 4–11 days) for the placebo group. There were three perinatal deaths in the placebo‐treated group and no deaths or serious adverse events attributable to pravastatin. Conclusions We found no evidence that pravastatin lowered maternal plasma sFlt‐1 levels once early‐onset pre‐eclampsia had developed. Pravastatin appears to have no adverse perinatal effects. Tweetable abstract Pravastatin does not improve maternal plasma sFlt‐1 or placental growth factor levels following a diagnosis of early preterm pre‐eclampsia #clinicaltrial finds.

OBJECTIVE: To determine the effects on the vaginal microbiota of an oral probiotic preparation administered from early pregnancy. \ud \ud DESIGN: Randomised, double blind, placebo-controlled trial. \ud \ud SETTING: Four maternity units in the UK. \ud \ud POPULATION: Women aged 16 years or older recruited at 9-14 weeks' gestation. \ud \ud METHODS: Participants were randomly allocated to receive oral capsules of probiotic containing Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each at 2.5 × 109 colony-forming units (CFUs) or placebo once daily from recruitment until the end of pregnancy. \ud \ud MAIN OUTCOME MEASURE: Rates of bacterial vaginosis (BV, defined as Nugent score ≥7) at 18-20 weeks' gestation compared by logistic regression adjusted for possible confounders. \ud \ud RESULTS: The primary analysis included 78% (238/304) of participants who initially consented (probiotic group 123, placebo group 115). Of these participants, 95% (227/238) reported an intake of 93% or more of the required number of capsules. The rates of BV did not differ between groups at 18-20 weeks' gestation (15% (19/123) in the probiotic group vs. 9% (10/115) in the placebo group, adjusted odds ratio 1.82, 95% confidence interval 0.64-5.19). There were also no differences between the groups in the proportion of women colonised with the probiotic strains, Escherichia coli, Group B streptococci or other vaginal microbiota. There were no differences in the alpha diversity or composition of the bacterial communities between or within the probiotic and placebo groups at 9-14 and 18-20 weeks' gestation. \ud \ud CONCLUSIONS: Oral probiotics taken from early pregnancy did not modify the vaginal microbiota. \ud \ud TWEETABLE ABSTRACT: The oral probiotic preparation used in this study does not prevent BV in pregnant women.

Objective Prospective registration of clinical trials has been required since 2005. We aimed to assess concordance between registered and reported sample sizes among prospectively registered randomised controlled trials (RCTs) in obstetrics and gynaecology. Design Analysis of prospectively registered and published data. Setting Women's health. Sample Obstetrics and gynaecology RCTs published in eight journals in 2015. Methods Specialist (Acta Obstet Gynecol Scand, BJOG, Obstet Gynecol and Am J Obstet Gynecol) and general (BMJ, N Engl J Med, JAMA and Lancet) journals were searched from 1 January to 31 December 2015 for main reports of obstetrics and gynaecology RCTs. Their corresponding registries and protocols were sought and data were extracted. Proportions and 95% CI were calculated using exact methods. Main outcome measures Prospective registration of RCT and sample size concordance between RCTs and their registries within those where registration took place before patients were recruited. Results Of the 75 relevant RCTs, 51 (68%, 95% CI 56–78%, P < 0.001 using a null hypothesis requiring 100% compliance) were prospectively registered, a feature found to be more common in general journals versus specialist journals (21/22 versus 30/53, 95% versus 57%, P = 0.001). Of the 51 prospectively registered RCTs, 31 (61%, 95% CI 46–74%, P = 0.003 using a null hypothesis requiring 40% of studies to achieve their stated sample size) did not reach the target sample size. Conclusions There are gaps in universal adoption of the prospective trial registration rule. Inability to meet target sample size risks deficiencies in statistical power with unreliability in results. Tweetable abstract Only two-thirds of RCTs in women's health are prospectively registered, and over half fail to achieve target sample sizes.

Background Syphilis in pregnancy can lead to fetal and neonatal death or congenital anomalies. Accurate on-site tests are an essential part of effective prevention of mother-to-child transmission of the disease. Objective This systematic review assessed the accuracy of on-site tests to detect infection with Treponema pallidum in pregnant women. Search strategy Major databases were searched from inception to January 2016 using terms: ‘pregnancy’, ‘antenatal’, ‘syphilis’, ‘Treponema pallidum’ with their variations, and the search limit for the relevant study design. Selection criteria We included studies that used dual reference standard (non-treponemal and treponemal tests) to detected syphilis in pregnancy. Data collection and analysis Extracted accuracy data were tabulated and pooled using hierarchical, bivariate random effects model. Main results Seven studies (combined sample 17 546) reporting the accuracy of four on-site tests met the eligibility criteria. On average, Determine™ and SD BioLine Syphilis 3.0 had the highest sensitivity of all the evaluated tests: 0.83 (95% CI 0.58, 0.98) and 0.86 (95% CI 0.82, 0.89), respectively, with a high specificity 0.96 (95% CI 0.89, 1.00) and 0.99 (95% CI 0.94, 1.00), respectively. The Qualitative Rapid Plasma Reagin card commonly used in clinical practice had a pooled sensitivity of 0.70 (95% CI 0.54, 0.88) and specificity of 0.97 (95% CI 0.96, 0.99). Conclusion Immunochromatographic tests such as Determine™ and SD BioLine Syphilis 3.0 seem to be acceptable options in antenatal testing for syphilis, especially in resource-limited settings. Future research should seek more evidence to strengthen this claim. Tweetable abstract On-site test to detect syphilis—options during antenatal care.

Katie’s Team is funded by a grant from the Centre for Public Engagement Queen Mary University of London.

Top Scoring Abstracts of the RCOG World Congress 2016, 20–22 June 2016, ICC Birmingham, United Kingdom

Objective To develop maternal, fetal, and neonatal composite outcomes relevant to the evaluation of diet and lifestyle interventions in pregnancy by individual patient data (IPD) meta-analysis. Design Delphi survey. Setting The International Weight Management in Pregnancy (i-WIP) collaborative network. Sample Twenty-six researchers from the i-WIP collaborative network from 11 countries. Methods A two-generational Delphi survey involving members of the i-WIP collaborative network (26 members in 11 countries) was undertaken to prioritise the individual outcomes for their importance in clinical care. The final components of the composite outcomes were identified using pre-specified criteria. Main outcome measures Composite outcomes considered to be important for the evaluation of the effect of diet and lifestyle in pregnancy. Results Of the 36 maternal outcomes, nine were prioritised and the following were included in the final composite: pre-eclampsia or pregnancy-induced hypertension, gestational diabetes mellitus (GDM), elective or emergency caesarean section, and preterm delivery. Of the 27 fetal and neonatal outcomes, nine were further evaluated, with the final composite consisting of intrauterine death, small for gestational age, large for gestational age, and admission to a neonatal intensive care unit (NICU). Conclusions Our work has identified the components of maternal, fetal, and neonatal composite outcomes required for the assessment of diet and lifestyle interventions in pregnancy by IPD meta-analysis. Tweetable abstract Composite outcomes in IPD meta-analysis on diet and lifestyle in pregnancy. Tweetable abstract Composite outcomes in IPD meta-analysis on diet and lifestyle in pregnancy. This article includes Author Insights, a video abstract available at https://vimeo.com/148890226

Objective To determine the relationship of interpregnancy interval with maternal and offspring outcomes. Design Retrospective study with data from the Perinatal Information System database of the Latin American Centre for Perinatology and Human Development, Uruguay. Setting Latin America, 1990–2009. Population A cohort of 894 476 women delivering singleton infants. Methods During 1990–2009 the Perinatal Information System database of the Latin American Centre for Perinatology identified 894 476 women with defined interpregnancy intervals: i.e. the time elapsed between the date of the previous delivery and the first day of the last normal menstrual period for the index pregnancy. Using the interval 12–23 months as the reference category, multiple logistic regression estimated adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs) of the association between various interval lengths and maternal and offspring outcomes. Main outcome measures Maternal death, pre-eclampsia, eclampsia, puerperal infection, fetal death, neonatal death, preterm birth, and low birthweight. Results In the reference interval there was 0.05% maternal death, 1.00% postpartum haemorrhage, 2.80% pre-eclampsia, 0.15% eclampsia, 0.28% puerperal infection, 3.45% fetal death, 0.68% neonatal death, 12.33% preterm birth, and 9.73% low birthweight. Longer intervals had increased odds of pre-eclampsia (>72 months), fetal death (>108–119 months), and low birthweight (96–107 months). Short intervals of

Journal Clubs inform clinicians, instil research literacy, andembed evidence-based practice. They also offer the oppor-tunity for post publication peer-review to identify weak-nesses in research, make suggestions for improvement, anddiscover implications for future research and clinical prac-tice; however, the deliberations of Journal Clubs are rarelyfed back for reflections from editors and authors.

Background Measurements of amniotic fluid volume are used for pregnancy surveillance despite a lack of evidence for their predictive ability. Objective To evaluate the association and predictive value of ultrasound measurements of amniotic fluid volume for adverse pregnancy outcome. Search strategy Electronic databases (inception to October 2011), reference lists, hand searching of journals, contact with experts. Selection criteria Studies comparing measurements of amniotic fluid volume with adverse outcome, excluding pre-labour ruptured membranes or congenital/structural anomalies. Data collection Data on study characteristics, design, quality. Random effects meta-analysis to estimate summary odds ratios (prognostic association) and summary sensitivity, specificity and likelihood ratios (predictive ability). Main results Forty-three studies (244 493 fetuses) were included demonstrating a strong association between oligohydramnios (varying definitions) and birthweight 8 cm or amniotic fluid index ≥25 cm) and birthweight >90th centile (OR 11.41, 95% CI 7.09–18.36; n = 1 study, 3960 fetuses). Despite strong associations, predictive accuracy for perinatal outcome was poor. Author's conclusion Current evidence suggests that oligohydramnios is strongly associated with being small for gestational age and mortality, and polyhydramnios with birthweight >90th centile. Despite strong associations with poor outcome, they do not accurately predict outcome risk for individuals.

OBJECTIVE: To undertake a cost-effectiveness analysis that compares positron emission tomography - computed tomography (PET-CT) imaging plus standard practice with standard practice alone in the diagnosis of recurrent or persistent cervical cancer during routine surveillance and follow-up of women who have previously been diagnosed and treated. DESIGN: Model-based economic evaluation using data from a systematic review, supplemented with data from other sources, and taking a UK National Health Service (NHS) perspective. SETTING: Secondary Care in England. POPULATION: Women at least 3 months after the completion of treatment, with either recurrent or persistent cervical cancer. METHODS: A state transition (Markov) model was developed using TreeAge Pro 2011. The structure of the model was informed by the reviews of the trials and clinical input. In the model, two diagnostic strategies were examined. A one-way sensitivity analysis, probabilistic sensitivity analysis, and a value of information analysis were also carried out. MAIN OUTCOME MEASURES: Cost-effectiveness based on incremental cost per quality-adjusted life year (QALY). RESULTS: Adding PET-CT to the current treatment strategy of clinical examination and scanning [magnetic resonance imaging (MRI) and/or CT scan] during the routine surveillance and follow-up of women with recurrent or persistent cervical cancer is significantly more costly, with only a minimal increase in effectiveness. The incremental cost-effectiveness ratio (ICER) for the strategy of PET-CT as an adjunct to the standard treatment strategy that included clinical examination, MRI, and/or CT scan, compared with the usual treatment alone, was over £1 million per QALY. CONCLUSION: The results of the current analysis suggest that use of PET-CT in the diagnosis of recurrent or persistent cervical cancer is not cost-effective. Current guidelines recommending imaging using PET-CT as a diagnostic or surveillance tool need to be reconsidered in light of these results. This study did not specifically investigate the use of PET-CT in women with symptoms and radiological suspicion of recurrence where exenteration was considered. More research in that specific area is required.

Background Positron emission tomography–computed tomography (PET-CT) is recommended to triage women for exenterative surgery and surveillance after treatment for advanced cervical cancer. Objective To evaluate diagnostic accuracy of additional whole body PET-CT compared with CT/magnetic resonance imaging (MRI) alone in women with suspected recurrent/persistent cervical cancer and in asymptomatic women as surveillance. Design Systematic reviews. Subjective elicitation to supplement diagnostic information. Search strategy/Selection criteria/Data collection and analysis Searches of electronic databases were performed to June 2013. Studies in women with suspected recurrent/persistent cervical cancer and in asymptomatic women undergoing follow up with sufficient numeric data were included. We calculated sensitivity, specificity and corresponding 95% confidence intervals. Meta-analyses employed a bivariate model that included a random-effects term for between-study variations (CT studies) and univariate random effects meta-analyses (PET-CT studies) for sensitivity and specificity separately. Subjective elicitation Prevalence of recurrence and the accuracy of imaging elicited using the allocation of points technique. Coherence of elicited subjective probabilities with estimates in the literature examined. Results We identified 15 relevant studies; none directly compared additional PET-CT with MRI or CT separately. Most CT and MRI studies used older protocols and the majority did not distinguish between asymptomatic and symptomatic women. Meta-analysis of nine PET-CT studies in mostly symptomatic women showed sensitivity of 94.8 (95% CI 91.2–96.9), and specificity of 86.9% (95% CI 82.2–90.5). The summary estimate of the sensitivity of CT for detection of recurrence was 89.64% (95% CI 81.59–94.41) and specificity was 76% (95% CI 43.68–92.82). Meta-analysis for MRI test accuracy studies was not possible because of clinical heterogeneity. The sensitivity and specificity of MRI in pelvic recurrence varied between 82 and 100% and between 78 and 100%, respectively. Formal statistical comparisons of the accuracy of index tests were not possible. Subjective elicitation provided estimates comparable to the literature. Subjective estimates of the increase in accuracy from the addition of PET-CT were less than elicited increases required to justify the use in PET-CT for surveillance. Conclusion Evidence to support additional PET-CT is scarce, of average quality and does not distinguish between application for surveillance and diagnosis. Guidelines recommending PET-CT in recurrent cervical cancer need to be reconsidered in the light of the existing evidence base.

EYL Leung, SA Tirlapur, D Siassakos, KS Khan a Women’s Health Research Unit, Centre of Public Health and Primary Care, Queen Mary, University of London, London, b School of Clinical Sciences, University of Bristol, Southmead Hospital, Bristol, UK Correspondence: Dr E Leung, Women’s Health Research Unit, Centre of Public Health and Primary Care, Yvonne Carter Building, 58 Turner Street, Queen Mary, University of London, London E1 2AB, UK. Email elaine.leung@qmul.ac.uk

Please cite this paper as: Cooper N, Smith P, Khan K, Clark T. Does cervical preparation before outpatient hysteroscopy reduce women’s pain experience? A systematic review. BJOG 2011;118:1292–1301. Background Studies examining the use of pharmaceutical (prostaglandins, antiprogestogens) and mechanical (osmotic dilators) dilatation of the cervix before hysteroscopy under general anaesthesia have produced conflicting results regarding their effect on cervical dilatation and trauma during the procedure. Objective To compare the effect on pain and need for cervical dilatation of various methods of cervical preparation before outpatient hysteroscopy. Search strategy MEDLINE, EMBASE and CINAHL were searched using a combination of the keywords ‘hysteroscopy’, ‘vaginoscopy’, ‘cervical ripening’, ‘laminaria’, ‘progest*’, ‘prostaglandin’, ‘oestrogen’‘cervical preparation’ and their associated Medical Subject Headings The Cochrane Library was searched using the keywords ‘hysteroscopy’ and ‘cervical’. There were no limits or filters placed on the searches. Selection criteria Randomised controlled trials that examined women undergoing outpatient hysteroscopy, where the intervention was the use of cervical preparation versus a control or placebo and the outcome was pain assessment. Data collection and analysis Two reviewers independently selected trials. Data were extracted on pain, the effect on dilatation, adverse effects, trauma and feasibility. Data regarding pain and cervical dilatation were unsuitable for meta-analysis. Meta-analyses were performed for adverse effects and feasibility using the random effects models to calculate the Peto odds ratio. Results From 585 abstracts, six studies were selected for inclusion in the systematic review. The results suggest that there may be a benefit of using prostaglandins for postmenopausal women; however, there is no high-quality evidence that giving misoprostol before outpatient hysteroscopy reduces the pain experienced by women of reproductive age. There is some evidence that prostaglandins reduce the force and requirement for dilatation of the cervix beyond 5 mm. Author’s conclusions There is no evidence to recommend the routine administration of mifepristone or misoprostol to women before outpatient hysteroscopy. Cervical priming with vaginal prostaglandins may be considered in postmenopausal women if using hysteroscopic systems >5 mm in diameter.

Please cite this paper as: Kaambwa B, Bryan S, Gray J, Milner P, Daniels J, Khan K, Roberts T. Cost-effectiveness of rapid tests and other existing strategies for screening and management of early-onset group B streptococcus during labour. BJOG 2010;117:1616–1627. Objective To determine the cost-effectiveness of alternative screening and prevention strategies, including rapid intrapartum testing, for prevention of early-onset neonatal group B streptococcus (GBS) infection in the UK. Design A decision model was developed to investigate the cost-effectiveness of screening and prevention strategies for GBS. A strategy of doing nothing was also considered. Deterministic and probabilistic sensitivity analyses were carried out. Setting Two large UK based obstetric units. Participants Test accuracy data were obtained from a primary study of rapid tests at the onset of labour and risk factors from 1400 women. Main outcome measures Incremental health sector costs per case of early-onset GBS death avoided. Results Compared with a strategy of do nothing, the incremental cost-effectiveness ratio was £32,000 per Early-Onset GBS Disease avoided and £427,000 per Early-Onset GBS Death avoided for the strategy of providing routine intrapartum antibiotic prophylaxis to all women without prior screening; Based on their current sensitivity, specificity and cost, screening using rapid tests was dominated by other more cost-effective strategies. Conclusions The most cost-effective strategy was shown to be the provision of routine intrapartum antibiotic prophylaxis to all women without prior screening but, given broader concerns relating to antibiotic use, this is unlikely to be acceptable. In its absence, intrapartum antibiotic prophylaxis directed by screening with enriched culture becomes cost-effective. The current strategy of risk-factor-based screening is not cost-effective compared with screening based on culture.

Objective To assess the accuracy and acceptability of polymerase chain reaction (PCR) and optical immunoassay (OIA) tests for the detection of maternal group B streptococcus (GBS) colonisation during labour, comparing their performance with the current UK policy of risk factor-based screening. Design Diagnostic test accuracy study. Setting and population Fourteen hundred women in labour at two large UK maternity units provided vaginal and rectal swabs for testing. Methods The PCR and OIA index tests were compared with the reference standard of selective enriched culture, assessed blind to index tests. Factors influencing neonatal GBS colonisation were assessed using multiple logistic regression, adjusting for antibiotic use. The acceptability of testing to participants was evaluated through a structured questionnaire administered after delivery. Main outcome measures The sensitivity and specificity of PCR, OIA and risk factor-based screening. Results Maternal GBS colonisation was 21% (19–24%) by combined vaginal and rectal swab enriched culture. PCR test of either vaginal or rectal swabs was more sensitive (84% [79–88%] versus 72% [65–77%]) and specific (87% [85–89%] versus 57% [53–60%]) than OIA (P < 0.001), and far more sensitive (84 versus 30% [25–35%]) and specific (87 versus 80% [77–82%]) than risk factor-based screening (P < 0.001). Maternal antibiotics (odds ratio, 0.22 [0.07–0.62]; P = 0.004) and a positive PCR test (odds ratio, 29.4 [15.8–54.8]; P < 0.001) were strongly related to neonatal GBS colonisation, whereas risk factors were not (odds ratio, 1.44 [0.80–2.62]; P = 0.2). Conclusion Intrapartum PCR screening is a more accurate predictor of maternal and neonatal GBS colonisation than is OIA or risk factor-based screening, and is acceptable to women.

Please cite this paper as: Fox C, Khan K, Coomarasamy A. How to interpret randomised trials of test–treatment combinations: a critical evaluation of research on uterine Doppler test to predict, and aspirin to prevent, pre-eclampsia. BJOG 2010;117:801–808. The methodology to evaluate either a test or treatment is well developed and understood. However, the design, conduct and interpretation of a combination of a test and a treatment in a single study are fraught with complexities. There are two distinct study designs to evaluate test–treatment combinations, with randomisation occurring either before or after the test. We present critical issues that need to be considered when evaluating and appraising test–treatment combinations, using the example of research on the uterine artery Doppler test to predict, and aspirin to prevent, pre-eclampsia.

Please cite this paper as: Cooper N, Smith P, Khan K, Clark T. Vaginoscopic approach to outpatient hysteroscopy: a systematic review of the effect on pain. BJOG 2010;117:532–539. Background Vaginoscopy, also known as the ‘no-touch’ technique, is an alternative method for performing hysteroscopy without the need for a vaginal speculum to view the cervix or cervical instrumentation to grasp and steady the cervix. Objective To examine the effect of a vaginoscopic approach to outpatient hysteroscopy on the patients’ experience of pain, compared with a traditional approach using a vaginal speculum. Search strategy MEDLINE, EMBASE, CINAHL and the Cochrane Library were searched for relevant articles. No filters or restrictions were placed on the searches. Selection criteria Randomised controlled trials (RCTs) that assess pain when comparing the vaginoscopic technique versus a traditional hysteroscopy in the outpatient setting. Data collection and analysis Two reviewers independently selected trials. Data were abstracted on quality, characteristics and results. Meta-analyses were performed using the random-effects model to calculate the standardised mean difference (SMD). Main results There were six trials (2851 participants). Data from four of these were meta-analysed, and we found that the use of the vaginoscopic approach to hysteroscopy was less painful than using the traditional technique (SMD −0.44, 95% CI from −0.65 to −0.22, I2 = 58%). There was no significant difference in the number of failed procedures between groups (P = 0.38). Author’s conclusions The vaginoscopic approach to outpatient hysteroscopy is successful and significantly reduces the pain experienced by patients during the procedure, compared with traditional techniques using a vaginal speculum. Vaginoscopy should become standard practice for endoscopic instrumentation of the uterine cavity in the outpatient setting.

Please cite this paper as: Morris R, Malin G, Khan K, Kilby M. Systematic review of the effectiveness of antenatal intervention for the treatment of congenital lower urinary tract obstruction. BJOG 2010;117:382–390. Background Congenital lower urinary tract obstruction is associated with high mortality and morbidity. Antenatal detection has improved with advances in ultrasound technology, and has allowed the option of antenatal intervention. Objectives To systematically review the literature to evaluate the effectiveness of antenatal interventions to improve perinatal survival and postnatal renal function in congenital lower urinary tract obstruction. Search strategy Extensive electronic searches (database inception 2009) using Medical Subject Headings (MeSH) and keywords, without restrictions. Reference lists of included studies were checked, and all authors were contacted. Selection criteria Studies were selected according to a predefined protocol. The included studies were observational or randomised trials, where an intervention was performed in utero to treat congenital lower urinary tract obstruction, compared with another intervention or no treatment. Data collection and analysis Data were extracted on study design, quality and results to construct 2 × 2 tables. Meta-analysis was performed where possible. Peto ORs with 95% CIs were computed. Main results Prenatal bladder drainage improved perinatal survival compared with no treatment (OR 3.86, 95% CI 2.00–7.45). This effect was amplified in a subgroup with poor predicted prognosis (OR 12.85, 95% CI 1.25–153.03). However, although treatment increases survival, it appears that the residual risk of poor long-term postnatal renal function is uncertain (OR 0.50, 95% CI 0.13–1.90). Author’s conclusions Antenatal bladder drainage appears to improve perinatal survival in cases of congenital lower urinary tract obstruction, but may confer a high residual risk of poor postnatal renal function, based on observational studies. Randomised research with long-term follow up is necessary to determine the role of antenatal treatment in clinical practice.

Objectives To estimate in a systematic review of the literature the diagnostic value of ultrasound and Doppler blood flow velocity in the evaluation of fetal anaemia. Study selection and data extraction Literature from 2000 to 2008 was identified using MEDLINE and EMBASE, the Cochrane Library and relevant specialist register of the Cochrane Collaboration, and by checking reference lists of known primary studies and review articles. Studies were selected if the accuracy of the fetal ultrasound parameters or Doppler studies of blood flow in the fetal vessels was estimated compared with a reference standard. Data from the selected studies were abstracted as 2 × 2 tables comparing the diagnostic test result with the reference standard. Results were pooled where appropriate. Diagnostic accuracy was expressed as likelihood ratios. Results Twenty-five primary studies were identified containing suitable data on middle cerebral artery Doppler peak systolic velocity (MCA-PSV). The largest group of studies whose data could be pooled containing nine studies gave a positive likelihood ratio of 4.30 (95% CI: 2.50 to 7.41) and a negative likelihood ratio of 0.30 (95% CI: 0.13 to 0.69) for 675 cases in detecting severe anaemia in the analysis. Discussion Although middle cerebral artery peak systolic velocity Doppler has limited diagnostic accuracy, it remains the gold standard for noninvasive screening of fetal anaemia.

To assess the trend in multicentre randomised controlled trials (RCTs), a database of 670 RCTs was assembled from four generic obstetric and gynaecological journals (Acta Obstetricia et Gynecologica Scandinavica, British Journal of Obstetrics & Gynaecology, Obstetrics & Gynecology and American Journal of Obstetrics & Gynecology) for 1975, 1980, 1985, 1990, 1995, 2000 and 2005. During this period, there was an inflationary trend with the proportion of published multicentre RCTs (from 12.9% in 1975 of all RCTs to 23.8% in 2005; P = 0.008). Multicentre RCTs had multiauthored publications (OR = 2.90; 95% CI 1.99-4.22) and more often received external funding (OR = 2.41; 95% CI 1.70-3.48) than single centre RCTs. The inflationary trend in multicentre RCTs requiring funding and collaboration represents the increasing complexity of medical research necessary to underpin evidence-based practice.

Background Congenital urinary tract obstruction can lead to perinatal mortality and morbidity. Assessing antenatal ultrasound features may help identify fetuses likely to suffer complications. Objective To evaluate the accuracy of antenatal ultrasound in the prediction of postnatal renal function in cases of congenital lower urinary tract obstruction (LUTO). Search strategy We conducted electronic searches in MEDLINE, EMBASE, the Cochrane Library, MEDION, SIGLE, SCISEARCH Index of scientific and technical proceedings, National Research Register (database inception – 2008) and Medical Conferences register and searched reference lists. Selection criteria Two reviewers independently selected articles in which the accuracy of fetal ultrasound features were evaluated to predict postnatal renal function with no language restrictions. Data collection and analysis Data were extracted on study characteristics, quality and results to construct 2 × 2 tables. Likelihood ratios for positive (LR+) and negative (LR−) test results, sensitivity and specificity were generated for the different ultrasound parameters and reference standards. Main results Thirteen articles that met the selection criteria, including 215 women and 33 2 × 2 tables. Meta-analysis was performed using clinically similar subgroups to minimise clinical heterogeneity. The ultrasound parameter that showed the best predictive value for postnatal renal function in survivors was renal cortical appearance, sensitivity 0.57 (95% CI 0.37–0.76) and specificity 0.84 (95% CI 0.71–0.94), area under the curve 0.78. Conclusion Measurement of amniotic fluid volume and the appearance of the renal cortex at diagnosis of LUTO show promising predictive accuracy for poor postnatal renal function.

Haemorrhage, a leading cause of maternal morbidity and mortality, is frequently associated with caesarean section. Allogeneic blood is an increasingly rare and scare resource. Intraoperative Cell Salvage (IOCS) offers the possibility of improving outcome and reducing allogeneic blood transfusion in cases of haemorrhage at caesarean section. The available literature on the use of IOCS in obstetrics demonstrates that there is limited evidence to support or refute the use of IOCS at caesarean section. However, this procedure has been introduced into obstetric practice. Before opinions about its use become solidified, there is a window of opportunity to launch a large multicentre randomised controlled trial to address the current equipoise.

Objective To assess the effects of aromatase inhibitors in women symptomatic of pain with endometriosis. Design A systematic review of published literature. Material and methods We conducted a comprehensive literature search to identify all the published observational and randomised studies evaluating the efficacy of aromatase inhibitors on pain associated with endometriosis. A combination of keywords was used to identify the maximum number of relevant citations in MEDLINE, EMBASE, CINAHL and the Cochrane Database. Outcome Pain relief, lesion size and quality of life. Results There were eight studies (137 women) evaluating outcomes of aromatase inhibitors. In case series/reports (seven studies, 40 women), aromatase inhibitors combined with progestogens or oral contraceptive pill or gonadotrophin-releasing hormone (GnRH) analogues reduced mean pain scores and lesion size and improved quality of life. An RCT (97 women) demonstrated that aromatase inhibitors in combination with GnRH analogues significantly improved pain (P < 0.0001) compared with GnRH analogues alone together with significant improvement in multidimensional patient scores (P < 0.0001). There was no significant reduction in spine or hip-bone densities. Conclusion Aromatase inhibitors appear to have a promising effect on pain associated with endometriosis, but the strength of this inference is limited due to a dearth of the evidence available.

Objective The objective of this study was to determine the accuracy of body mass index (BMI) (pre-pregnancy or at booking) in predicting pre-eclampsia and to explore its potential for clinical application. Design Systematic review and bivariate meta-analysis. Setting Medline, Embase, Cochrane Library, MEDION, manual searching of reference lists of review articles and eligible primary articles, and contact with experts. Population Pregnant women at any level of risk in any healthcare setting. Methods Reviewers independently selected studies and extracted data on study characteristics, quality, and accuracy. No language restrictions. Main outcome measures Pooled sensitivities and specificities (95% CI), a summary receiver operating characteristic curve, and corresponding likelihood ratios (LRs). The potential value of BMI was assessed by combining its predictive capacity for different prevalences of pre-eclampsia and the therapeutic effectiveness (relative risk 0.90) of aspirin. Results A total of 36 studies, testing 1 699 073 pregnant women (60 584 women with pre-eclampsia), met the selection criteria. The median incidence of pre-eclampsia was 3.9% (interquartile range 1.4–6.8). The area under the curve was 0.64 with 93% of heterogeneity explained by threshold differences. Pooled estimates (95% CI) for all studies with a BMI ≥ 25 were 47% (33–61) for sensitivity and 73% (64–83) for specificity; and 21% (12–31) and 92% (89–95) for a BMI ≥ 35. Corresponding LRs (95% CI) were 1.7 (0.3–11.9) for BMI ≥ 25 and 0.73 (0.22–2.45) for BMI < 25, and 2.7 (1.0–7.3) for BMI ≥ 35 and 0.86 (0.68–1.07) for BMI < 35. The number needed to treat with aspirin to prevent one case of pre-eclampsia ranges from 714 (no testing, low-risk women) to 37 (BMI ≥ 35, high-risk women). Conclusions BMI appears to be a fairly weak predictor for pre-eclampsia. Although BMI is virtually free of cost, noninvasive, and ubiquitously available, its usefulness as a stand-alone test for risk stratification must await formal cost-utility analysis. The findings of this review may serve as input for such analyses.

Objective To determine the most cost-effective outpatient testing strategy for diagnosing endometrial cancer in women with postmenopausal bleeding (PMB). Design Decision analysis modelling. Population Women with postmenopausal bleeding. Methods A decision analytic model was constructed to reflect current service provision, which evaluated 12 diagnostic strategies using endometrial biopsy (EB), ultrasonography (USS) (4- and 5-mm endometrial thickness cutoff) and hysteroscopy. Diagnostic probability estimates were derived from systematic quantitative reviews, clinical outcomes from published literature and cost estimates from local and NHS sources. Main outcome measures The cost per additional life year gained (£/LYG) was determined and compared for each diagnostic strategy, and sensitivity analyses were performed. Results Compared with carrying out no initial investigation, a strategy based on initial diagnosis with USS using a 5-mm cutoff was the least expensive (£11 470/LYG). Initial investigation with EB or USS using a 4-mm cutoff was comparably cost-effective (less than £30 000/LYG versus USS with a 5-mm cutoff) at their most favourable diagnostic performance and at disease prevalence of 10% or more. The strategies involving initial evaluation with test combinations or hysteroscopy alone were not cost-effective. Conclusions Women presenting for the first time with PMB should undergo initial evaluation with USS or EB.

Background Currently, there are a number of clinical trials, but no international collaboration for collating research on effectiveness of laparoscopic uterosacral nerve ablation (LUNA) for alleviating chronic pelvic pain. Objective Meta-analysis was used by collecting individual patient data (IPD) from the existing trials, to provide a comprehensive assessment of the effectiveness of LUNA that will be generalisable in various clinical contexts. Methods IPD will be sought and collected from all relevant (both already finished and continuing) randomised trials identified through previous systematic reviews. After obtaining raw data and cleaning the database, analysis will be of all patients ever randomised based on the intention-to-treat principle using endpoints measured at 12 months following randomisation. Proposal We will update searches, contact all authors, obtain data in whatever form it can be provided, build a single database, produce results for individual studies, have them verified by original authors, explore of any heterogeneity and reasons behind it and finally pool all raw data in to a meta-analysis using appropriate statistical methods. The project will test the effectiveness of LUNA for women with chronic pelvic pain. It will also motivate collaborating primary investigators to undertake new primary studies to corroborate or improve upon the conclusions derived from the retrospective analysis.

Objectives: The primary objective is to determine whether intrauterine vesicoamniotic shunting for fetal bladder outflow obstruction, compared with conservative, noninterventional care, improves prenatal and perinatal mortality and renal function. The secondary objectives are to determine if shunting for fetal bladder outflow obstruction improves perinatal morbidity, to determine if improvement in outcomes is related to prognostic assessment at diagnosis and, if possible, derive a prognostic risk index and to determine the safety and long-term efficacy of shunting. Design: A multicentre randomised controlled trial (RCT). Setting: Fetal medicine units. Population: Pregnant women with singleton, male fetus with isolated lower urinary tract obstruction (LUTO). Methods: Following ultrasound diagnosis of LUTO in a male fetus and exclusion of other structural and chromosomal anomalies, participation in the trial will be discussed with the mother and written information given. Consent for participation in the trial will be taken and the mother randomised via the internet to either insertion of a vesicoamniotic shunt or expectant management. During pregnancy, both groups will be followed with regular ultrasound scans looking at viability, renal measurements and amniotic fluid volume. Following delivery, babies will be followed up by paediatric nephrologists/urologists at 4-6 weeks, 12 months and 3 and 5 years to assess renal function via serum creatinine, renal ultrasound and need for dialysis/transplant. Main outcome measures: The main outcome measures will be perinatal mortality rates and renal function at 4-6 weeks and 12 months measured via serum creatinine, renal ultrasound and need for dialysis/transplant. Funding: Wellbeing of Women. Estimated completion date: September 2010.