Re: Training in the use of intrapartum electronic fetal monitoring with cardiotocography: systematic review and meta‐analysis. Cardiotocography training is a complex intervention and requires complex evaluations: a letter to editor.Lightly K, Weeks AD, Scott HCorrespondence to Dr Kate Lightly – klightly@liverpool.ac.uk07875642837Clinical Research Fellow, Sanyu Research Unit, University of Liverpool and Liverpool Women’s NHS Foundation Trust, members of Liverpool Health Partners, Crown Street, Liverpool, L8 7SS.Professor Andrew D WeeksProfessor of International Maternal Health, Sanyu Research Unit, University of Liverpool and Liverpool Women’s NHS Foundation Trust, members of Liverpool Health Partners, Crown Street, Liverpool, L8 7SS.Professor Hazel ScottDean of School of Medicine, School of Medicine, University of Liverpool, Cedar House, Liverpool, L69 3GE.Running title - CTG training requires complex evaluationsWe congratulate Kelly et al on their review on the effects of training in cardiotocography (CTG).i It is a critical step towards understanding how to correctly implement CTG training. However, we query the relevance of some of the included studies and whether using Kirkpatrick’s model adequately captures all of the relevant complexities. We believe that further work is needed to understand how such training will impact on practice.Some of the CTG research projects reviewed were poorly representative of the needs of clinicians tasked with improving fetal monitoring in their hospitals. For clinicians, their population of interest is practising clinicians who work on labour wards (sometimes infrequently); studies involving undergraduates alone may not be generalisable. Training in intermittent auscultation is also relevant. Considerable detail on the training intervention is required, including not only the format of teaching, but the duration, curriculum and proportion of relevant staff trained. Detail is also required of supporting interventions and context, as training alone is unlikely to impact change. Many would consider ‘no training’ unethical and therefore not a relevant comparator . In the UK, CTG training and competency is now required for all maternity staff.ii The ultimate aim of CTG (and therefore CTG training) is to detect the hypoxic fetus, so that timely intervention can be undertaken to avoid perinatal harm, without unnecessary intervention. Therefore, the outcomes of interest have to include intrapartum stillbirths, hypoxic ischaemic encephalopathy and mode of delivery.Kirkpatrick’s model was used in this review to evaluate training at four levels (reaction, knowledge, behaviour change and organisational performance). However, it does not attempt to understand why interventions work, or the context, or the causal pathways between training and change in practice.iii Whether participants like training (‘reaction’) is of little relevance, and knowledge acquisition (‘knowledge’) is a proxy which does not equate with improved on the job performance and outcomes. Maternal and perinatal outcomes (‘performance’) were only collected in a small number of studies.CTG training is a complex intervention which aims to create change, not simply knowledge acquisition. We therefore believe that a formal Realist Evaluation is needed. This emerging methodology has been used successfully to understand healthcare change processes and supplement traditional Cochrane style reviews. It aims to understand why complex interventions work, how, for whom, in what context and to what extentiv. Collaboration with the relevant authors to gain detailed intervention descriptions, with a realist approach, may add some much needed explanatory power to this critical subject.Training alone is unlikely to impact change. Even the best educational package will fail without the necessary support - it needs an educational and working culture which supports learning and change, aligned and clear policies, and motivated, well supported drivers and leaders.How doctors learn and what supports them to put new knowledge into practice are key research questions. High quality, methodologically appropriate, properly funded studies are needed to address these questions. Not answering them means many research findings are redundant, as they simply will not be implemented.ReferencesI Kelly S, Redmond P, King S, Oliver‐Williams C, Lamé G, Liberati E et al. Training in the use of intrapartum electronic fetal monitoring with cardiotocography: systematic review and meta‐analysis. BJOG. 2021; 00: 1–12. https://doi.org/10.1111/1471-0528.16619ii NHS England. Saving Babies’ Lives Version Two. A care bundle for reducing perinatal mortality. London: NHS England 2019. [cited 2021 Feb 3]. Available from: www.england.nhs.ukiii Moreau KA. Has the new Kirkpatrick generation built a better hammer for our evaluation toolbox? Med Teach. 2017 Sep; 39(9): 999-1001. https://doi.org/10.1080/0142159X.2017.1337874iv Wong G, Westhorp G, Greenhalgh J, Manzano A, Jagosh J, Greenhalgh T. Quality and reporting standards, resources, training materials and information for realist evaluation: the RAMESES II project. Health Services and Delivery Research. 2017 5 (28): 1–108. https://doi.org/10.3310/hsdr05280.Acknowledgements – NilDisclosure of interests - NilContribution to authorshipKL wrote the first draft of this letter and then it was revised by AW and HS.Details of ethics approval – N/AFunding – Dr Lightly’s PhD entitled “Improving intrapartum fetal monitoring in India: A mixed methods approach” is funded by MRC/DfID/Wellcome Trust Joint Global Health Trials Fund. MR/R006/1801

Objective: To determine the incidence of and risk factors for perioperative blood transfusions after urogenital fistula repairs in Uganda. Design: A retrospective cohort study. Setting: A community hospital in Masaka, Uganda. Population: Women who underwent fistula repair at the Kitovu Hospital between 2013 and 2019. Methods: Retrospective review of demographics, and clinical perioperative characteristics of patients surgically treated for urogenital fistula. Patient characteristics were compared between those who did and did not require a blood transfusion. Main Outcome Measures: need for perioperative blood transfusion, risk factors Results: 546 patients treated for urogenital fistulas were included in this study. The median age was 31.1 ± 13.2. A vaginal surgical approach was used in the majority of patients (84.6%). Complications occurred in 3.5% of surgical repairs, and the incidence of blood transfusions was 6.2%. In multivariable analyses, women with fistula repairs approached abdominally were 4.3 (95% CI: 1.85–10.00) times more likely to require transfusions than vaginal operations. A borderline association was observed between timing of repair and perioperative transfusions such that patients who underwent repair after three months from the time of developing the fistula were at lower risk of perioperative transfusions (aOR: 0.48, 95% CI: 0.22–1.04). Conclusions: The incidence of blood transfusions among urogenital fistula repairs in our population is twice that of developed nations. An abdominal surgical approach to urogenital fistula is a significant risk factor for perioperative blood transfusions. Timing of repair may warrant further study.

Abstract Objective: Pregnant women may develop disseminated intravascular coagulation (DIC), possibly resulting in massive maternal haemorrhage and perinatal death. The Japan guideline recommends use of antithrombin Ⅲ (ATⅢ) for DIC in obstetrics; however, its effect remains uncertain. The present study therefore aimed to investigate the effect of ATⅢ for DIC patients in obstetrics, using a national inpatient database in Japan. Design: Nationwide observational study Setting: Japan Population: We used the Diagnosis Procedure Combination inpatient database to identify patients who delivered at hospital and were diagnosed with DIC from July 2010 to March 2018. Methods: Propensity score matching analyses were performed to compare in-hospital maternal mortality and hysterectomy during hospitalization between users and non-users of ATⅢ on the day of delivery. Main Outcome Measures: In-hospital mortality, hysterectomy Results: A total of 9,920 patients were enrolled, including 4,329 patients (44%) who used ATⅢ and 5,511 patients (56%) who did not use ATⅢ. One-to-one propensity score matching created 3290 pairs. In-hospital maternal mortality did not differ significantly between the propensity-matched groups (0.3% in the ATⅢ group vs. 0.5% in the control group; odds ratio, 0.73; 95% confidence interval, 0.35–1.54). Patients in the ATⅢ group, compared with those in the control group, had a significantly lower proportion of receiving hysterectomy during hospitalization (5.3% vs. 8.7%; difference, -2.9%; 95% confidence interval, -4.2 to -1.6%). Conclusions: The present study did not show mortality-reducing effect of ATIII for patients with DIC in obstetrics. ATⅢ may have clinical benefit in terms of reduction in receiving hysterectomy.

OBJECTIVE: The objective of this study was to evaluate C-section rates, before and after the implementation of the Project Appropriate Birth based on the Robson 10-group classification system. DESIGN: An observational, cross-sectional study. SETTING: Maternity hospital in South Brazil. POPULATION: All pregnant women attending, April 2016 through April 2017 (phase 1, pre-implementation of the Project Appropriate Birth) and June 2017 through June 2018 (phase 2, post-implementation of the Project Appropriate Birth). METHODS: Maternal and obstetric characteristics were evaluated, including Robson’s classification, based on the characteristics of pregnancy and childbirth. Chi-square test and crude and adjusted prevalence ratios were used to analyze study variables. The significance level was set at 5%. MAIN OUTCOME MEASURES: C-section rate for each group, their contribution to the overall c-section rate and the differences in these contributions before and after PPA implementation. RESULTS: C-section rates decreased from 62.4% to 55.6%, which represented a 10.9% reduction after the implementation of the Project Appropriate Birth. Pregnant women in Robson classification groups 1 through 4 had the greatest decrease in C-section rates, ranging from 49.1% to 38.6%, which represents a 21.5% reduction. The greatest contributors to the overall C-section rates were group 5 and group 2, accounting for more than 60% of the C-section deliveries. CONCLUSION: The Project Appropriate Birth had an important impact on the reduction of C-section rates, especially in Robson classification groups 1 through 4, which indicates that providing mothers with evidence-based interventions for labor and childbirth assistance will contribute to reduce C-section rates.

Objective: Long-term cost-effectiveness of app-based treatment for female stress, urgency, or mixed urinary incontinence (UI) compared to care-as-usual in primary care. Design: A pragmatic, randomised controlled, superiority trial. Setting: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. Population: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. 262 women randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up. Methods: The standalone app included conservative management for UI with motivation aids (e.g., reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. Main outcome measures: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTS-QoL, EQ-5D-5L) on superiority with linear regression on an intention-to-treat basis. Cost-effectiveness and -utility from a societal perspective, based on Incontinence Impact Adjusted Life Years (IIALYs) and Quality Adjusted Life years (QALYs). Results: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6), with a non-significant mean difference of 0.903 (-0.66 to 1.871). Costs were lower for app-based treatment with \euro-161 (95%CI: -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger ICER (-3,696) and ICUR (\euro6,379). Conclusion: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of long-term cost-effectiveness. Funding: Dutch Organisation for Health Research and Development (ZonMw: 837001508), sub-funding P.W. Boer Foundation Dutch Trial Register identifier: Trial NL4948 (www.trialregister.nl/trial/4948).

Background Pregnancy and childbirth increase the risk for pelvic floor dysfunction, including sexual dysfunction. So far, the mechanisms and the extent to which certain risk factors play a role, remain unclear. Objectives In this systematic review of literature, we aimed to determine the risk factors for sexual dysfunction in the first year after delivery. Search Strategy We searched MEDLINE, Embase and CENTRAL using the search strategy: Sexual dysfunction AND Obstetric events. Selection Criteria We included original English, comparative studies that used validated questionnaires and the ICS/IUGA terminology for sexual dysfunction, dyspareunia and vaginal dryness. Data Collection and Analysis We assessed the quality and the risk of bias of the included studies with the Newcastle Ottawa Scale. We extracted the reported data and we performed random-effects meta-analysis to obtain the summary Odds Ratios (OR) with 95% Confidence Intervals. Heterogeneity across studies was assessed using the I2 statistic. Main Results We found no significant difference in the odds for both sexual dysfunction and dyspareunia between cesarean section and spontaneous delivery (OR:1.17[0.88-1.57] and OR:0.75[0.53-1.07]) and between operative delivery and spontaneous delivery (OR:1.56[0.87-2.79] and OR:1.35[0.75-2.42]). Anal sphincter injury was associated with increased odds for both sexual dysfunction (OR:3.00[1.28-7.03]) and dyspareunia (OR:1.71[1.09-2.67]). Episiotomy was associated with dyspareunia (OR:1.65[1.20-2.29]) but not with sexual dysfunction (OR:1.90[0.94-3.84]). We retrieved one study of low quality which reported on vaginal dryness and found no significant association with obstetric events.

Risk stratification of HPV positive women in routine cervical screeningHigh risk HPV primary screening is replacing organised cytology-based screening based on increased sensitivity to detect high grade intra-epithelial neoplasia and the very high negative predictive value which will allow extended screening intervals. The benefit of increased CIN detection and cancer prevention needs to balance against the disbenefits to screen positive women in over investigation not east the psychological impact. For colposcopy services, the English cervical screening programme reported a 80% increase in colposcopy referrals in the first round of screening, creating huge pressures on service capacity (Rebolj M et al BMJ 2019;364:l240). The lower positive predictive value also impacts on colposcopy performance with a different referral population wit proportionately less high grade CIN present. In this issue of BJOG, Gori M et al provide observational data from a large longitudinal study of routine primary HPV screening in an organised quality assured cervical screening programme in 3 regions of Italy. Whilst routinely collected data from real-world programmes will have limitations, they do provide an insight into disease detection and importantly impact on colposcopy provision. In a comparison of triage strategies, combined HPV genotyping for HPV16 and high-grade cytology offered an acceptable balance of risk of CIN3+ with number of colposcopies needed to detect one lesion. These results differ from the English pilot (Rebolj M et al 2019 BJC;121(6):455-463) where HPV16/18 genotyping detected only 1.2% more cases of CIN2+ with 5.9% additional colposcopies. Gori M et al did not combine HPV16/18 but they did report that HPV18 on genotyping was not as clinically useful at baseline or 12-month follow-up. Furthermore, 90% of women screened were aged over 35 years when HPV screening is more clinically effective whereas the English pilot started screening at age 25 years when HPV infection is more prevalent and less likely to be clinically significant. Longer follow-up, importantly at the next screening round, is not yet available when the relevance of non-HPV 16 types may be more apparent.The impact of the Covid 19 pandemic on health services and in particular screening, has sharpened the argument of risk stratification following primary screen positive testing both for service providers and those in the target population. Ciavattini A et al (2020 Int J Cancer 30(8):1097-1100) reported on suspension or postponement of cervical screening programmes across Europe relevant to both routine screening and onward referral to colposcopy. As services have needed to adapt to Covid infection rates and health service capacity, the ability to triage effectively and avoid unnecessary hospital visits is critical. Clinicians and women need information on their risk to inform clinical practice and provide reassurance. In the current second wave, the suspension of screening implemented in the first wave is no longer acceptable. Whilst data, such as these from Gori et al, continue to emerge from national and regional screening programmes, Covid has highlighted the need to be responsive and adaptive to allow cancer prevention to continue.

A document by Jianghui Cai. Click on the document to view its contents.

Mini-commentary on BJOG-20-1156.R2: Post-mortem confirmation of fetal brain abnormalities: challenges highlighted by the MERIDIAN cohort study

A document by Nathan Gold. Click on the document to view its contents.

Mini-commentary on BJOG-20-1640.R2: Aetiologic testing compared with syndromic management for sexually transmitted infections in Human Immunodeficiency Virus-infected pregnant women in South Africa: a non-randomised prospective cohort study

Mini Commentary: BJOG-20-1978.R1Title: Complement Receptors in Preeclampsia: Cleaning up Placental DebrisAuthor: Richard M. Burwick, MD, MPHAffiliation: Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, CA

Known knowns, unknown unknowns and everything in-between

Letter to the Editor, BJOG Exchange

A document by Adrian Gaspar. Click on the document to view its contents.

Mini-commentary on BJOG-20-1239.R3: Intramuscular oxytocin versus Syntometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: a randomised double blinded clinical trial of effectiveness, side effects and quality of life

Objective To develop a Core Outcome Set (COS) for treatment of perinatal depression Design Systematic overview of outcomes reported in the literature and consensus development study using a Delphi survey and modified nominal group technique. Setting International. Population Two hundred and twenty-two participants, representing thirteen countries. Methods A systematic overview of outcomes reported in recently published research, a two-round Delphi survey, a consensus meeting at which the final COS was decided. Main results In the literature search, 1772 abstracts were identified and evaluated, 284 papers/protocols were assessed in full and 165 studies were finally included in the review. In all, 106 outcomes were identified and thus included in the Delphi survey. 222 participants registered for the first round of the Delphi survey and 151 (68%) responded. In the second round, 123 (55%) participants responded. The following 9 outcomes were agreed upon for inclusion in the final COS: self-assessed symptoms of depression, diagnosis of depression by a clinician, parent to infant bonding, self-assessed symptoms of anxiety, quality of life, satisfaction with intervention, suicidal thoughts, attempted or committed suicide, thoughts of harming the baby, and adverse events. Conclusions The relevant stakeholders prioritised outcomes and reached consensus on a COS comprising nine outcomes. We hope that this COS will contribute to consistency and uniformity of outcome selection and reporting in future clinical trials involving treatment of perinatal depression Funding This article is adapted from a report by SBU, which provided funding for the study. Keywords: perinatal depression, postpartum depression, antenatal depression, COS

Objective To compare the effectiveness, safety and acceptability of medical abortion before and after the introduction of no-test telemedicine Design Cohort study Setting The three main abortion providers in England Population All patients having an early medical abortion (comprising 85% of all medical abortions performed nationally) Methods Comparison of no-test telemedicine hybrid model vs. traditional model (blanket in-person provision including ultrasound), adjusted for baseline differences Main outcome measures Access: waiting time, gestation Effectiveness: successful medical abortion Safety: significant adverse events; ectopic pregnancy and late gestation Acceptability: Patient-reported outcomes Results 52,142 medical abortions were conducted, 29,984 in the telemedicine-hybrid cohort and 22,158 in the traditional cohort. Mean waiting times were 4.2 days shorter in the telemedicine-hybrid cohort and 40% were ≤6 weeks’ gestation vs. 25% in the traditional cohort (p<0.001). There was no difference in success rates (98.8% vs. 98.2%, p=1.0), nor in prevalence of serious adverse events (0.02% vs. 0.04%, p=0.557). Incidence of ectopic pregnancy was equivalent in both cohorts (0.2%, p=0.796); 0.04% of abortions appeared to have been provided after 10 weeks’ gestation with all completed safely at home. In the telemedicine-hybrid cohort, effectiveness was higher in the telemedicine group vs. the in-person group (99.2% vs. 98.1%, p<0.001). Acceptability was high (96% satisfied), 80% reported a future preference for telemedicine, and none reported that they were unable to consult in private using teleconsultation. Conclusions Medical abortion provided through a hybrid model that includes no-test telemedicine without ultrasound is effective, safe, acceptable, and improves access to care. Funding None