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COVID-19 has resulted in unprecedented changes to maternity care across Australia. This study aims to analyse trends in maternity consultations and the uptake of telehealth in Victoria and New South Wales (NSW) since the first restrictions to reduce COVID-19 transmission were implemented. From March 2020 to April 2021, a higher proportion of antenatal care consultations was delivered via telehealth in Victoria compared to NSW (13.8% vs 7.4%, P < 0.0001). Uptake of telehealth and a shift from in-person care has been a major contributor to maintaining pregnancy care during pandemic restrictions. However, further research is required to understand women's perspectives and health outcomes.Copyright © 2021 Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Background: Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk is needed to plan management. Objective(s): To assess the performance of existing pre-eclampsia prediction models and to develop and validate models for pre-eclampsia using individual participant data meta-analysis. We also estimated the prognostic value of individual markers. Design(s): This was an individual participant data meta-analysis of cohort studies. Setting(s): Source data from secondary and tertiary care. Predictors: We identified predictors from systematic reviews, and prioritised for importance in an international survey. Primary outcomes: Early-onset (delivery at < 34 weeks' gestation), late-onset (delivery at >= 34 weeks' gestation) and any-onset pre-eclampsia. Analysis: We externally validated existing prediction models in UK cohorts and reported their performance in terms of discrimination and calibration.We developed and validated 12 new models based on clinical characteristics, clinical characteristics and biochemical markers, and clinical characteristics and ultrasound markers in the first and second trimesters. We summarised the data set-specific performance of each model using a random-effects meta-analysis. Discrimination was considered promising for C-statistics of >= 0.7, and calibration was considered good if the slope was near 1 and calibration-in-the-large was near 0. Heterogeneity was quantified using I2 and 2. A decision curve analysis was undertaken to determine the clinical utility (net benefit) of the models. We reported the unadjusted prognostic value of individual predictors for pre-eclampsia as odds ratios with 95% confidence and prediction intervals. Result(s): The International Prediction of Pregnancy Complications network comprised 78 studies (3,570,993 singleton pregnancies) identified from systematic reviews of tests to predict pre-eclampsia. Twenty-four of the 131 published prediction models c

Objective: Induction of labor (IOL) is one of the most common obstetric interventions, with cervical ripening required for half of all inductions. Randomized clinical trials comparing balloon catheters and vaginal prostaglandins are generally underpowered for safety outcomes. We aim to compare effectiveness and safety by re-analyzing individual participant data from numerous trials comparing these two methods of cervical ripening. Study Design: Raw data was sought from eligible RCTs comparing balloon catheters and vaginal prostaglandins (PGE1 and/or PGE2). The primary outcomes were caesarean section (CS) and its indications (i.e., fetal compromise or failure to progress), a composite of adverse perinatal outcome (Apgar < 7 at 5 min, arterial umbilical cord pH < 7.1, admission to NICU, seizures, severe respiratory compromise, infection, neonatal death, or stillbirth), and a composite of adverse maternal outcome (admission to ICU, infection, severe postpartum hemorrhage, or death). The analysis followed intention-to-treat and considered clustering within trials. Result(s): We identified 13 eligible RCTs of which data was available from eight (3772 participants) with the data from three PROBAAT combined (PROBAAT 1+M+P). IOL with balloon catheters and vaginal prostaglandins did not have significantly different rates of CS (RR 1.09, 95% CI 0.97-1.22). However, balloon catheters were associated with significantly higher rates of CS for failure to progress (RR 1.23, 95% CI 1.01-1.51; Figure 1). CS for fetal compromise occurred less often, although the difference was not statistically significant (RR 0.85, 95% CI 0.66-1.09). Balloon catheters were associated with reduced composite adverse perinatal outcomes (Figure 2) compared to vaginal prostaglandins (RR 0.80, 95% CI 0.67-0.97). There were no differences noted for composite adverse maternal outcomes between the two methods (RR 1.00, 95% CI 0.86-1.16). Conclusion(s): For cervical ripening in IOL, balloon catheters and vagi

Evidence-based medicine tries to support clinicians through research, integrated with clinical skill and patient values. This pilot study aimed to assess appropriateness and level of evidence of current clinical practices, through evaluating availability and quality of guidelines. A prospective observational study in a large tertiary hospital network was performed, sampling diagnostic and therapeutic interventions in obstetrics and gynaecology. Interventions performed were justified against knowledge in the published literature, and guideline recommended practice. We collected 58 patient observations, 40(69%) in obstetrics, 18(31%) in gynaecology. There were local guidelines relevant in 52%, national in 22%, and international guidelines in 12%. In 50 interventions with available guidelines, 54% provided strong and clear recommendations for practice, and were supported by research-based knowledge. Similarly, 66% of encounters were thought to be in concordance with research-based knowledge. There was good concordance between interventions and guideline recommendations. However, half of guidelines reviewed had limited or no knowledge to justify their recommendations.IMPACT STATEMENTWhat is already known on this subject? Evidence based medicine should aim to improve patient outcomes. However, available trials assessing effectiveness of established practices suggest that they convey little to no benefit to patients. There remains a paucity of evidence for established practices in obstetrics and gynaecology What do the results of this study add? This pilot study assesses the usefulness of interventions in obstetrics and gynaecology and confirms the feasibility of collecting and coding our interventions and clinical practices with a traffic light system. What are the implications of these findings for clinical practice and/or further research? These findings demonstrate the feasibility of our traffic lights grading system within obstetrics and gynaecology. It demonstrates

OBJECTIVE: To systematically review the performance of soluble fms-like tyrosine kinase-1 (sFlt-1), placental growth factor (PlGF), and the sFlt-1/PlGF ratio in predicting adverse outcomes in women with preeclampsia. DATA SOURCES: We performed a systematic search of MEDLINE, EMBASE, CINAHL, Cochrane, Scopus, ClinicalTrials.gov, and Emcare databases from 1989 to March 2019 to identify studies correlating sFlt-1, PlGF, and the sFlt-1/PlGF ratio with the occurrence of adverse outcomes in women with preeclampsia. METHODS OF STUDY SELECTION: Two independent reviewers screened 3,194 studies using Covidence. Studies were included if they examined the performance of sFLT-1, PlGF, or the sFLT-1/PlGF ratio in predicting adverse outcomes in women with suspected or confirmed preeclampsia. TABULATION, INTEGRATION, AND RESULTS: We extracted contingency tables with true-positive, false-positive, true-negative, and false-negative results. We calculated sensitivity, specificity, diagnostic odds ratios, and area under the summary receiver operating characteristic curve (area sROC) through a bivariate mixed-effects meta-analysis. Our literature search identified 3,194 articles, of which 33 (n=9,426 patients) were included. There was significant variation in the included studies with regard to the biomarkers and outcomes assessed. As such, few studies (n=4-8) were included in the meta-analysis component with significant heterogeneity between studies (I2=33-99). Nonetheless, both PlGF and the sFlt-1/PlGF ratio demonstrated area sROC values between 0.68 and 0.87 for the prediction of composite adverse maternal and perinatal outcomes, preterm birth and fetal growth restriction. CONCLUSION(S): Placental growth factor and the sFlt-1/PlGF ratio show prognostic promise for adverse outcomes in preeclampsia, but study heterogeneity limits their clinical utility. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42019136207.Copyright © 2020 by the American College of Obstetricians and Gynecologists.

OBJECTIVE: Induction of labor (IOL) is one of the most widely used obstetric interventions. However, one-fifth of labor inductions end with cesarean section (CS). We aimed to assess maternal and fetal characteristics that influence the likelihood of CS following IOL by indications. METHOD(S): This is a secondary analysis of pooled data from four randomized control trials on IOL. The main outcomes of this analysis were CS for failure to progress (FTP) and CS for suspected fetal compromise (SFC). Restricted cubic spline was used to explore non-linear relationships for continuous characteristics. Optimal cut-offs for non-linear patterns were determined with maximized Area Under the Curve. Adjusted odds ratios were computed with logistic regressions. RESULT(S): Among a total of 2990 women, 313 women had CS for FTP and 227 for SFC. Regarding the risk of CS for FTP, women aged 30-35 were at elevated risk (aOR 1.51, 95% CI 1.15-1.99) compared with younger women. Nulliparous women had a higher risk than multiparous women (aOR 8.07, CI 5.34-12.18). Incremental BMI increased the risk (aOR 1.06, CI 1.04-1.08). Higher birthweight percentile, using 20-49.9% as a reference, also carried a higher risk for CS due to FTP (for 80-89.9%, aOR 2.66, CI 2.71-4.07; for >=90% aOR 4.08, CI 2.75-6.05). For CS due to SFC, incremental maternal age (aOR 1.09, CI 1.05-1.12) and BMI (aOR 1.05, CI 1.03-1.08) were associated with increased risk. Compared with multiparous women, nulliparous women had increased risk (aOR 5.91, CI 3.76-9.28). Low birthweight percentile (<10%) carried a significantly higher risk for CS due to SFC (aOR 1.93, CI 1.22-3.05) compared to those in the 20-49.9% category. Bishop score did not demonstrate a significant relationship with predicting CS rate as compared to vaginal delivery. CONCLUSION(S): Maternal age, BMI, parity, and birthweight percentile are predictors of CS following IOL both for FTP and SFC, but with different directions and magnitude. These characteristics

Objective To investigate the impact of COVID-19 mitigation measures on perinatal outcomes, specifically in women with previous preterm birth. Design Comparative cohort study. Setting Large maternity care setting in Melbourne, Australia. Methods We compared a cohort of women exposed to mitigation measures who conceived between 1 November 2019 and 29 February 2020 (intervention group) to a cohort of women exposed to mitigation measures who conceived between 1 November 2018 and 28 February 2019 (control group). Both cohorts were followed from 20 weeks of gestation onwards. Women with pregnancies complicated by major fetal abnormalities were excluded from the analysis. In the intervention cohort, a short period of mild mitigation measures for four weeks was applied between 12-24 weeks gestation, with much stricter measures for four months starting between 20-36 weeks of gestation until beyond 37 weeks. The control group was formed by women pregnant a year earlier who underwent care as usual. The primary outcome was delivery before 34 weeks of gestation or stillbirth. Main secondary outcome was a composite of poor perinatal outcome. In subgroup analyses, we assessed the impact in nulliparous women, women with previous preterm birth, women with previous term birth, and women with a multiple pregnancy. Results We studied 3150 women who were pregnant while mitigation measures came in place and 3175 women who had usual care. The primary outcome occurred in 95 (3.0%) of the pregnancies during lockdown versus 126 (4.0%) in the control group (Risk ratio (RR) 0.76, 95% CI 0.58 to 0.99, P = 0.039). The composite for poor perinatal neonatal outcome occurred in 69 (2.1%) versus 96 (2.9%) (RR 0.73; 95% CI 0.54-0.99). NICU admittance > 48 h reduced from 4.8% to 3.4% (RR 0.71; 95% CI 0.56-0.90) with a reduction of length of NICU stay of 8 days (P = 0.07). The effect was strongest in women with previous preterm birth (preterm birth < 34 weeks/stillbirth RR 0.42, 95% CI 0.21 to 0.82, P

OBJECTIVES: To compare, in women with infertility, the effectiveness and safety of tubal flushing using oil-based contrast medium, water-based contrast medium or their combination, and no tubal flushing, and to evaluate the effectiveness of tubal flushing on fertility outcome over time. METHOD(S): We performed a systematic review and network meta-analysis, searching the electronic databases MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials, and trial registries, up to 25 September 2018. We included randomized controlled trials (RCTs) comparing the following interventions with each other or with no intervention in women with infertility: tubal flushing using water-based contrast medium, tubal flushing using oil-based contrast medium or additional tubal flushing with oil-based medium following diagnostic tubal flushing with water-based medium. The outcomes included clinical pregnancy, live birth, ongoing pregnancy, miscarriage, ectopic pregnancy and adverse events. RESULT(S): Of the 283 studies identified through the search, 14 RCTs reporting on 3852 women with infertility were included. Network meta-analysis showed that tubal flushing using oil-based contrast medium was associated with higher odds of clinical pregnancy within 6months after randomization and more subsequent live births compared with tubal flushing using water-based medium (odds ratio (OR), 1.67 (95% CI, 1.38-2.03), moderate certainty of evidence; and OR, 2.18 (95% CI, 1.30-3.65), low certainty of evidence, respectively) and compared with no intervention (OR, 2.28 (95% CI, 1.50-3.47), moderate certainty of evidence; and OR, 2.85 (95% CI, 1.41-5.74), low certainty of evidence, respectively). These results agreed with those of the pairwise meta-analysis. For clinical pregnancy within 6 months, there was insufficient evidence of a difference between tubal flushing with water-based contrast medium and no intervention (OR, 1.36 (95% CI, 0.91-2.04), low certainty of evidence). For fertility

Introduction Induction of labour (IOL) is a common practice. In Australia, up to 40% of women undergoing labour induction will ultimately have a caesarean section. As a biological role for melatonin in the onset and progress of labour has been demonstrated, we aim to test the hypothesis that addition of melatonin will reduce the need for caesarean section. Methods and analysis This is a double-blind, randomised, placebo-controlled trial in women undergoing IOL at term. We plan to randomise 722 women (1:1 ratio) to receive either melatonin (four doses of 10 mg melatonin: first dose-in the evening at the time of cervical balloon or Dinoprostone PGE 2 vaginal pessary insertion, second dose-at time of oxytocin infusion commencement, third dose-6 hours after the second dose, fourth dose-6 hours after the third dose) or placebo (same dosing regime). Participants who are having artificial rupture of the membranes only as the primary means of labour induction will receive up to three doses of the trial intervention. The primary outcome measure will be the requirement for a caesarean section. Secondary outcomes will include duration of each stage of labour and time from induction to birth, total dose of oxytocin administration, epidural rate, indication for caesarean section, rate of instrumental deliveries, birth within 24 hours of induction commencement, estimated blood loss, Apgar score at 5 min, neonatal intensive care unit admissions and participant satisfaction. Maternal melatonin levels will be measured immediately before commencement of the oxytocin intravenous infusion and 3 hours after and at the time of birth in order to determine any differences between the two trial arms. Ethics and dissemination The study is conducted in accordance with the conditions of Monash Health HREC (RES-17-0000-168A). Findings from the trial will be disseminated through peer-reviewed publications and conference presentations. Protocol version V.7.0, 30 July 2019. Trial registration numb

Background: Increasing numbers of women >=40 years old are accessing assisted reproductive technology (ART) due to age-related infertility. There is limited population-based evidence about the impact on the cumulative live birth rate (CLBR) of women aged >=40 years using their own oocytes, compared to women of a similar age, using donor oocytes. Aim(s): To compare the CLBR for women >=40 years undergoing ART using autologous oocytes and women of similar age using donor oocytes. Material(s) and Method(s): This population-based retrospective cohort study used data from all women aged >=40 years undergoing ART with donated (n = 987) or autologous oocytes (n = 19 170) in Victoria, Australia between 2009 and 2016. A discrete-time survival model was used to evaluate the CLBR following ART with donor or autologous oocytes. The odds ratio, adjusted for woman's age; male age; parity; cause of infertility; and the associated 95% confidence intervals (CI), were calculated. The numbers needed to be exposed (NNEs) were calculated from the adjusted odds ratio (aOR) and the CLBR in the autologous group. Result(s): The CLBR ranged from 28.6 to 42.5% in the donor group and from 12.5% to 1.4% in the autologous group. The discrete-time survival analysis with 95% CI demonstrated significant aOR on CLBR across all ages (range aOR: 2.56, 95% CI: 1.62-4.01 to aOR: 15.40, 95% CI: 9.10-26.04). Conclusion(s): Women aged >=40 years, using donor oocytes had a significantly higher CLBR than women using autologous oocytes. The findings can be used when counselling women >=40 years about their ART treatment options and to inform public policy.Copyright © 2020 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Background: Women with a history of preeclampsia are at increased risk of cardiovascular morbidity and mortality. However, the underlying mechanisms of disease association, and the ideal method of monitoring this high-risk group, remains unclear. This review aims to determine whether women with a history of preeclampsia show clinical or subclinical cardiac changes when evaluated with an echocardiogram. Methods and Results: A systematic search of MEDLINE, EMBASE, and CINAHL databases was performed to identify studies that examined cardiac function in women with a history of preeclampsia, in comparison with those with normotensive pregnancies. In the 27 included studies, we found no significant differences between preeclampsia and nonpreeclampsia women with regard to left ventricular ejection fraction, isovolumetric relaxation time, or deceleration time. Women with a history of preeclampsia demonstrated a higher left ventricular mass index and relative wall thickness with a mean difference of 4.25 g/m2 (95% CI, 2.08, 6.42) and 0.03 (95% CI, 0.01, 0.05), respectively. In comparison with the nonpreeclampsia population, they also demonstrated a lower E/A and a higher E/e' ratio with a mean difference of -0.08 (95% CI, -0.15, -0.01) and 0.84 (95% CI, 0.41, 1.27), respectively. Conclusion(s): In comparison with women who had a normotensive pregnancy, women with a history of preeclampsia demonstrated a trend toward altered cardiac structure and function. Further studies with larger sample sizes and consistent echocardiogram reporting with the use of sensitive preclinical markers are required to assess the role of echocardiography in monitoring this high-risk population group.Copyright © 2019 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Background: Preeclampsia is a major cause of mortality and morbidity worldwide. Agents such as soluble fms-like tyrosine kinase (sFlt-1), placental growth factor (PlGF) and soluble endoglin (sEng) reflect the angiogenic balance in preeclampsia and may have a role in prediction of disease and adverse outcomes. Method(s): We conducted this study according to PRISMA guidelines. We performed a systematic search of MEDLINE, EMBASE, CINAHL, Cochrane, Scopus, and Emcare from 1989 to March 2019 to identify studies correlating sFlt-1, PlGF and sEng levels in women with preeclampsia and the occurrence of adverse outcomes. We extracted 2x2 tables, odds ratios, mean/ median values and regression values and combined relevant results through a random effects bivariate meta-analysis. Result(s): We identified 2923 non-duplicate articles and narrowed down to 41 studies with 12183 cases after abstract and full text screening. There was significant variation in study population, sampling gestational age, outcomes, and presentation of data (2x2 tables vs odds ratios). As a result, we found low statistical power (n = 4-6) and extremely high heterogeneity (I2 value 34-100) between adverse outcomes investigated in the metaanalysis. Despite this, PlGF, and the sFlt-/PlGF ratio demonstrated pooled area under the curve values of 0.68-0.84 for predicting various adverse outcomes. Conclusion(s): PlGF and sFlt-1/PlGF show strong promise as prognostic markers in preeclampsia. However, current clinical application is not recommended due to low power and high levels of heterogeneity. In future, cohort studies with homogeneous characteristics must be adopted to better characterise the effects of serum biomarkers for risk-stratification of patients with preeclampsia.

Objective: The aim of this study is to identify items of economic evaluation guidelines that are frequently not complied within obstetric economic evaluations and to search for reasons for non-adherence. Design(s): Scoping review and qualitative study. Setting(s): Literature on economic evaluations in obstetric care and interviews with experts. Population or sample: The sample included 229 scientific articles and five experts. Method(s): A systematic literature search was performed. All types of literature about economic evaluations in obstetric care were included. The adherence to guidelines was assessed and articles were qualitatively analysed on additional information about reasons for non-adherence. Issues that arose from the scoping review were discussed with experts. Main Outcome Measure(s): Adherence to guideline items of the included economic evaluations studies. Analytical themes describing reasons for non-adherence, resulting from qualitative analysis of articles and interviews with experts. Result(s): A total of 184 economic evaluations and 45 other type of articles were included. Guideline items frequently not complied with were time horizon, type of economic evaluation and effect measure. Reasons for non-adherence had to do with paucity of long-term health data and assessing and combining outcomes for mother and child resulting from obstetric interventions. Conclusion(s): This study identified items of guidelines that are frequently not complied with and the reasons behind this. The results are a starting point for a broad consensus building on how to deal with these challenges that can result in special guidance for the conduct of economic evaluations in obstetric care. Tweetable abstract: Non-adherence to guidelines in obstetric economic evaluation studies: the difficulties in detail.Copyright © 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians

STUDY QUESTION: Do randomised controlled trials (RCTs) evaluating endometrial scratching suffer from methodological issues including insufficient trial registration, statistical errors or irreproducibility, randomisation errors or miscellaneous issues? SUMMARY ANSWER: The majority of RCTs investigating endometrial scratching have methodological issues. WHAT IS KNOWN ALREADY: A large number of small RCTs investigating the effectiveness of endometrial scratching prior to in vitro fertilisation (IVF) and intrauterine insemination (IUI)/intercourse have reported favourable findings. Subsequently, systematic reviews incorporating these RCTs yielded meta-analyses in favour of endometrial scratching. Endometrial scratching has been widely adopted by infertility specialists around the world. Recently, an international RCT including 1364 women reported no benefit from endometrial scratching before IVF. STUDY DESIGN, SIZE, DURATION: We evaluated several methodological issues of RCTs investigating the effectiveness of endometrial scratching prior to IVF and IUI/intercourse. We identified 25 RCTs for IVF and 12 RCTs for IUI/intercourse with full-text publication. PARTICIPANTS/MATERIALS, SETTING, METHODS: We assessed the RCTs on the following criteria: adequacy of trial registration, statistical issues (description of statistical methods and reproducibility of univariable statistical analysis), excessive similarity or difference in baseline characteristics that is not compatible with chance (Monte Carlo simulations and Kolmogorov-Smirnov test) and miscellaneous methodological issues. MAIN RESULTS AND THE ROLE OF CHANCE: Of 25 RCTs evaluating endometrial scratching prior to IVF, only eight (32%) had adequate trial registration. In total, 10 (40%) RCTs had issues regarding statistical methods. Nine (69%, 13 applicable) RCTs had at least one inconsistency between reported and reproduced univariable statistical analysis for categorical baseline/intermediate characteristics. Statisti

Research question: Does clinical performance of personalized embryo transfer (PET) guided by endometrial receptivity analysis (ERA) differ from frozen embryo transfer (FET) or fresh embryo transfer in infertile patients undergoing IVF? Design: Multicentre, open-label randomized controlled trial; 458 patients aged 37 years or younger undergoing IVF with blastocyst transfer at first appointment were randomized to PET guided by ERA, FET or fresh embryo transfer in 16 reproductive clinics. Result(s): Clinical outcomes by intention-to-treat analysis were comparable, but cumulative pregnancy rate was significantly higher in the PET (93.6%) compared with FET (79.7%) (P = 0.0005) and fresh embryo transfer groups (80.7%) (P = 0.0013). Analysis per protocol demonstrates that live birth rates at first embryo transfer were 56.2% in PET versus 42.4% in FET (P = 0.09), and 45.7% in fresh embryo transfer groups (P = 0.17). Cumulative live birth rates after 12 months were 71.2% in PET versus 55.4% in FET (P = 0.04), and 48.9% in fresh embryo transfer (P = 0.003). Pregnancy rates at the first embryo transfer in PET, FET and fresh embryo transfer arms were 72.5% versus 54.3% (P = 0.01) and 58.5% (P = 0.05), respectively. Implantation rates at first embryo transfer were 57.3% versus 43.2% (P = 0.03), and 38.6% (P = 0.004), respectively. Obstetrical outcomes, type of delivery and neonatal outcomes were similar in all groups. Conclusion(s): Despite 50% of patients dropping out compared with 30% initially planned, per protocol analysis demonstrates statistically significant improvement in pregnancy, implantation and cumulative live birth rates in PET compared with FET and fresh embryo transfer arms, indicating the potential utility of PET guided by the ERA test at the first appointment.Copyright © 2020 The Authors

STUDY QUESTION: What are the key core outcomes to be reported in studies on polycystic ovary syndrome (PCOS)? SUMMARY ANSWER: We identified 3 generic and 30 specific core outcomes in 6 specialist domains: metabolic (8), reproductive (7), pregnancy (10), oncological (1), psychological (1) and long-term outcomes (1). WHAT IS KNOWN ALREADY: Research reporting PCOS is heterogeneous with high variation in outcome selection, definition and quality. STUDY DESIGN, SIZE, DURATION: Evidence synthesis and a modified Delphi method with e-surveys were used as well as a consultation meeting. PARTICIPANTS/MATERIALS, SETTING, METHODS: Overall, 71 health professionals and 123 lay consumers (women with lived experience of PCOS and members of advocacy and peer support groups) from 17 high-, middle- and low-income countries were involved in this analysis. MAIN RESULTS AND THE ROLE OF CHANCE: The final core outcome set included 3 generic outcomes (BMI, quality of life, treatment satisfaction) that are applicable to all studies on women with PCOS and 30 specific outcomes that were categorised into six specialist domains: 8 metabolic outcomes (waist circumference, type 2 diabetes, insulin resistance, impaired glucose tolerance, hypertension, coronary heart disease, lipid profile, venous thromboembolic disease); 7 reproductive outcomes [viable pregnancy (confirmed by ultrasound including singleton, twins and higher multiples), clinical and biochemical hyperandrogenism, menstrual regularity, reproductive hormonal profile, chronic anovulation, ovulation stimulation success including the number of stimulated follicles >= 12 mm, incidence and severity of ovarian hyperstimulation syndrome]; 10 pregnancy outcomes (live birth, miscarriage, stillbirth, neonatal mortality, gestational weight gain, gestational diabetes, preterm birth, hypertensive disease in pregnancy, baby birth weight, major congenital abnormalities); 3 psychological outcomes (depression, anxiety, eating disorders); 1 oncological

Objective: To investigate the impact of a history of previous naturally conceived tubal ectopic pregnancy (TEP) on subsequent IVF/intracytoplasmic sperm injection (ICSI) pregnancy and perinatal outcomes. Design(s): Retrospective cohort study. Setting(s): Reproductive medicine center in a tertiary hospital. Patient(s): A total of 2,892 women with tubal infertility undergoing the first fresh IVF/ICSI cycle. Intervention(s): Women were stratified into three groups according to the type of previous naturally conceived pregnancy: TEP, intrauterine pregnancy (IUP), and no pregnancy. Main Outcomes Measure(s): Pregnancy and neonatal outcomes were analyzed for each cohort and stratified into the following categories based on female age: <30 years, 30-35 years, and >=35 years. Result(s): Of the 2,892 patients with tubal factor infertility, 511 (17.7%) women had a history of TEP, 1,044 (36.1%) had prior IUP, and 1,337 (46.2%) had never been pregnant. Couples with an initial TEP tended to be younger and had experienced a shorter duration of infertility. Across the whole cohort, the optimal live birth rate decreased in older age groups. Live birth rates stratified by maternal age (<30, 30-35, >=35 years) did not differ between the TEP group (59.9%, 53.7%, 45.5%) and the IUP (62.0%, 53.8%, 40.6%) and no pregnancy group (56.7%, 54.4%, 45.6%). This did not change after adjusting for confounders such as age and years of infertility. Previous treatment of TEP with salpingectomy, salpingostomy, or medical treatment did not significantly affect subsequent fertility outcomes. The rates of preterm and low birth weight after TEP were also not significantly higher than in women with a previous IUP. Conclusion(s): Fertility history, including previous TEP, does not influence the probability of live birth after IVF/ICSI in women with tubal factor infertility.Copyright © 2019 American Society for Reproductive Medicine

Research question: To evaluate the findings of outpatient transvaginal hydrolaparoscopy (THL) in comparison with diagnostic laparoscopy combined with chromopertubation in subfertile women. Design(s): In a retrospective study in four large teaching hospitals, all subfertile women who underwent a THL and a conventional laparoscopy as part of their fertility work-up in the period between 2000 and 2011 were studied. Findings at THL were compared with findings at diagnostic and therapeutic laparoscopies. Tubal occlusion, endometriosis and adhesions were defined as abnormalities. Result(s): Out of 1119 women, 1103 women underwent THL. A complete evaluation or incomplete but diagnostic procedure could be performed in 989 (89.7%) and 28 (2.5%), respectively. An incomplete non-diagnostic procedure was performed in 11 (1.0%) women. Failure of THL occurred in 75 women (6.8%) and 40 of these women (3.6%) subsequently underwent laparoscopy. Laparoscopy was performed in a total of 126 patients with a median time interval of 7 weeks (interquartile range [IQR] 3-13 weeks). Of 64 patients who successfully underwent both THL and laparoscopy, concordant findings were found in 53 women and discordant results in 11 women, 6 of which were caused by tubal spasm. Sensitivity of THL in detecting abnormalities was 100% and specificity was 22.2%, with a likelihood ratio of 1.29. Conclusion(s): THL in an outpatient setting can detect anatomical abnormalities comparable to the more invasive reference standard diagnostic laparoscopy. If THL succeeds, there is no need to add a diagnostic laparoscopy in the work-up.Copyright © 2019 Reproductive Healthcare Ltd.

STUDY QUESTION: Over a time period of 3 years, which order of expectant management (EM), IUI with ovarian stimulation (IUI-OS) and IVF is the most cost-effective for couples with unexplained subfertility with the female age below 38 years? SUMMARY ANSWER: If a live birth is considered worth e32 000 or less, 2 years of EM followed by IVF was the most cost-effective, whereas above e32 000 this was 1 year of EM, 1 year of IUI-OS and then 1 year of IVF. WHAT IS KNOWN ALREADY: IUI-OS and IVF are commonly used fertility treatments for unexplained subfertility although many couples can conceive naturally, as no identifiable barrier to conception could be found by definition. Few countries have guidelines on when to proceed with medically assisted reproduction (MAR), mostly based on the expected probability of live birth after treatment, but there is a lack of evidence to support the strategies proposed by these guidelines. The increased uptake of IUI-OS and IVF over the past decades and costs related to reimbursement of these treatments are pressing concerns to health service providers. For MAR to remain affordable, sustainable and a responsible use of public funds, guidance is needed on the cost-effectiveness of treatment strategies for unexplained subfertility, including EM. STUDY DESIGN, SIZE, DURATION: We developed a decision analytic Markov model that follows couples with unexplained subfertility of which the woman is under 38 years of age for a time period of 3 years from completion of the fertility workup onwards. We divided the time axis of 3 years into three separate periods, each comprising 1 year. The model was based on contemporary evidence, most notably the dynamic prediction model for natural conception, which was combined with MAR treatment effects from a network meta-analysis on randomized controlled trials. We changed the order of options for managing unexplained subfertility for the 1 year periods to yield five different treatment policies in total: IVF-E

Background: In routine antenatal care, blood pressure is used as a screening tool for preeclampsia and its associated adverse outcomes. As such women with a blood pressure greater than 140/90 mm Hg undergo further investigation and closer follow-up, whereas those with lower blood pressures receive no additional care. In the nonpregnant setting, the American College of Cardiology now endorses lower hypertensive thresholds and it remains unclear whether these lower thresholds should also be considered in pregnancy. Objective(s): (1) To examine the association between lower blood pressure thresholds (as per the American College of Cardiology guidelines) and pregnancy outcomes and (2) to determine whether there is a continuous relationship between blood pressure and pregnancy outcomes and identify the point of a change at which blood pressure is associated with an increased risk of such outcomes. Study Design: This was a retrospective study of singleton pregnancies at Monash Health, Australia. Data were obtained with regards to maternal characteristics and blood pressure measurements at varying gestational ages. Blood pressures were then categorized as (1) mean arterial pressure and (2) normal, elevated, stage 1 and stage 2 hypertension, as per the American College of Cardiology guidelines. Multivariable regression analysis was performed to identify associations between blood pressure categories and pregnancy outcomes. Result(s): This study included 18,243 singleton pregnancies. We demonstrated a positive dose-response relationship between mean arterial pressure and the development of preeclampsia in later pregnancy. Across all gestational ages, the risk of preeclampsia was greater in those with "elevated blood pressure" and "stage 1 hypertension" in comparison with the normotensive group (adjusted risk ratio; 2.45, 95% confidence interval, 1.74-3.44 and adjusted risk ratio, 6.60; 95% confidence interval, 4.98-8.73 respectively, at 34-36 weeks' gestation). There was als

OBJECTIVE: To compare the effectiveness and safety of Foley catheter and oral misoprostol for induction of labor (IOL). METHOD(S): The Cochrane Review on Mechanical Methods for Induction of Labour and Ovid MEDLINE, EMBASE via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov and Scopus, from inception to April 2019, were searched for randomized controlled trials (RCTs) comparing Foley catheter to oral misoprostol for IOL in viable singleton gestations. Eligible trials for which raw data were obtained were included and individual participant data meta-analysis was performed. Primary outcomes were vaginal birth, a composite of adverse perinatal outcome (including stillbirth, neonatal death, neonatal seizures, admission to the neonatal intensive care unit, severe respiratory compromise or meconium aspiration syndrome) and a composite of adverse maternal outcome (including admission to the intensive care unit, maternal infection, severe postpartum hemorrhage, maternal death or uterine rupture). The quality of the included RCTs was assessed using the Cochrane Risk of Bias 2 tool and the certainty of evidence was evaluated using the GRADE approach. A two-stage random-effects model was used for meta-analysis according to the intention-to-treat principle and interactions between treatment and baseline characteristics were assessed. RESULT(S): Of seven eligible trials, four provided individual participant data for a total of 2815 participants undergoing IOL, of whom 1399 were assigned to Foley catheter and 1416 to oral misoprostol. All four trials provided data for each of the primary outcomes in all 2815 women. Compared with those receiving oral misoprostol, Foley catheter recipients had a slightly decreased chance of vaginal birth (risk ratio (RR), 0.95 (95%CI, 0.91-0.99); I2 , 2.0%; moderate-certainty evidence). A trend towards a lower rate of composite adverse perinatal outcome was found in women undergoing IOL using a Foley catheter compared with oral misoprostol (RR

Objective: Ectopic pregnancy is a potentially life-threatening health problem that affects fertility and generates a significant economic burden. Optimal management, including when to choose methotrexate, and whether to do salpingectomy or salpingostomy, is still unclear. This study aimed to assess the quality and utility of research on ectopic pregnancy in the last three decades. Study design: We analyzed the quantity, quality and utility of the published literature, including 6,309 articles published over a 30-year period. We searched PubMed for studies on ectopic pregnancy, with subsequent analysis utilizing bibliometric network maps. Consolidated Standards of Reporting Trials (CONSORT) guidelines and a newly adapted checklist for usefulness of research were applied to assess randomized controlled trial (RCT) quality. Result(s): The initial search returned 14,727 articles, of which, after filters of publication date (1987/01/01 to 2017/12/31), species (Human) and language (English) were applied, 6,309 articles remained. The number of publications each year remained relatively stable, with a mean number of 280 articles published three decades ago versus 248 articles published on average in the last decade. The 7,733 human species articles published between 1987-2017 were written in 27 different languages, with 82 % in English. Publications in 14 selected high-impact journals accounted for 26.5 % (1,673/6,309) of all articles, with on average 54 publications per year across three decades. An increase in systematic reviews and meta-analyses (+1000 %), and case reports (+53 %) was seen between 1987-2017, while the percentage of RCTs (-25 %) decreased. The analyzed RCTs were of moderate quality, and few addressed the most important clinical questions. Conclusion(s): In the last three decades, both the number of articles on ectopic pregnancy and the number of articles in high-impact journals have remained stable. Despite these constant numbers, the quality of RCTs was

Objective: To compare the effectiveness of different treatments for women with endometriosis-related infertility. Design(s): A systematic review and network meta-analysis of randomized controlled trials (RCTs). Setting(s): Not applicable. Patient(s): Women with endometriosis confirmed by laparoscopy with associated infertility. Intervention(s): An extensive electronic search of the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov, and Embase. Main Outcome Measure(s): Clinical pregnancy, live birth rate, miscarriage, and adverse events. Result(s): A total of 4,252 trials/abstracts were identified through the literature search, of which we included 36 trials in the systematic review and 26 trials reporting on 2,245 women with endometriosis-related infertility in the network meta-analysis. Network meta-analysis showed that compared with placebo, surgical laparoscopy alone (odds ratio = 1.63; 95% confidence interval, 1.13-2.35) or GnRH agonist alone (odds ratio = 1.68; 95% confidence interval, 1.07-2.46) results in higher odds of pregnancy. The evidence on the other interventions versus placebo or on the secondary outcomes including live birth, miscarriage, and adverse events is insufficient. Conclusion(s): The most important conclusion is that more RCTs are needed to clarify the relative effectiveness of treatments for endometriosis-related infertility, ideally comparing interventions to existing recommended interventions such as surgical laparoscopy. In addition, further RCTs comparing IVF and IUI to other treatments are essential. Registration number: PROSPERO registration number, CRD42018087572Copyright © 2019 American Society for Reproductive Medicine