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Background: Previous spontaneous preterm birth (sPTB) is a strong risk indicator for recurrent preterm birth (PTB). Cervical cerclage is an accepted intervention to prevent recurrent PTB in high risk patients. Cervical pessary might be a less invasive alternative. The objective of this study is to determine whether a cervical pessary is non-inferior to cerclage in the prevention of recurrent PTB., Methods: We performed an international, open-label, non-inferiority, randomised controlled trial in 21 hospitals between March 2014 and December 2022. We included singleton pregnancies with an indication for cerclage based on either multiple previous sPTBs <34 weeks or with a previous sPTB <34 weeks and an asymptomatic mid-trimester short cervix (≤25 mm). Randomisation was 1:1, stratified by centre and indication, to cervical pessary or vaginal cerclage. Primary outcome was PTB <32 weeks. Secondary outcomes included (s)PTB rates, obstetric, and maternal outcomes and a composite of adverse perinatal outcomes including perinatal mortality and severe neonatal morbidity. Analysis was by intention-to-treat. Treatment effect was expressed as relative risk (RR), absolute risk difference (aRD) and 95% confidence intervals (CI). Sample size was calculated at 400 participants with a non-inferiority margin for pessary of 10%, meaning that non-inferiority is proven if the upper limit of the CI of the risk difference is <10%. Trial registration at ICTRP: NL-OMON26958., Findings: We randomised 261 participants to pessary (n = 133) or cerclage (n = 128). After the third interim analysis (n = 228 participants), recruitment was halted due to safety concerns and the apparent challenge in establishing non-inferiority of pessary treatment. PTB <32 weeks occurred in 44/130 cases after pessary vs 30/125 cases after cerclage (33.8% vs 24.0% aRR 1.4, 95% CI 0.95-2.1, p = 0.09, aRD 9.8% 95% CI -1.2 to 20.9). The composite of adverse perinatal outcomes occurred in 42 cases after pessary compared to 29 cases in cerclage (32.2% vs 23.2%; RR 1.4 95% CI 0.93-2.1 p = 0.1) and consisted mainly of perinatal death (22.3% vs 14.4% RR 1.5 95% CI 0.9-2.6 p = 0.1)., Interpretation: Non-inferiority of cervical pessary compared to cerclage in preventing recurrent PTB <32 weeks was not proven. Cerclage is the recommended treatment., Funding: ZonMw (#837002406), a Dutch Organisation for Health Research and Development., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. BMT reports receiving consulting fees for participation to the advisory board of Effik, Pierre-Favre and Sanofy, received payment for legal expert testimonies in malpractice cases in obstetrics and received a device to measure cervical softening from Pregnolia. BWM received an investigator grant from NHMRC. MAO received research grants for studies on the prevention of preterm birth, reports expenses paid for organization of preterm birth symposium, is chairman of the Fetal-Maternal Medicine board of the Dutch society of Obstetrics & Gynecology and chairman of the scientific committee of the Fetal-Maternal-Medicine Board. MAO and EP are board members of Stichting Stoptevroegbevallen, a non-profit organization supporting preterm birth research and received payments to the institution. EP received research grants for studies on prevention and treatment of preterm birth and the fetal microbiome., (© 2024 The Author(s).)

Objectives: In patients with an ovarian mass, a risk of malignancy assessment is used to decide whether referral to an oncology hospital is indicated. Risk assessment strategies do not perform optimally, resulting in either referral of patients with a benign mass or patients with a malignant mass not being referred. This process may affect the psychological well-being of patients. We evaluated cancer-specific distress during work-up for an ovarian mass, and patients' perceptions during work-up, referral, and treatment., Methods: Patients with an ovarian mass scheduled for surgery were enrolled. Using questionnaires we measured (1) cancer-specific distress using the cancer worry scale, (2) patients' preferences regarding referral (evaluated pre-operatively), and (3) patients' experiences with work-up and treatment (evaluated post-operatively). A cancer worry scale score of ≥14 was considered as clinically significant cancer-specific distress., Results: A total of 417 patients were included, of whom 220 (53%) were treated at a general hospital and 197 (47%) at an oncology hospital. Overall, 57% had a cancer worry scale score of ≥14 and this was higher in referred patients (69%) than in patients treated at a general hospital (43%). 53% of the patients stated that the cancer risk should not be higher than 25% to undergo surgery at a general hospital. 96% of all patients were satisfied with the overall work-up and treatment. No difference in satisfaction was observed between patients correctly (not) referred and patients incorrectly (not) referred., Conclusions: Relatively many patients with an ovarian mass experienced high cancer-specific distress during work-up. Nevertheless, patients were satisfied with the treatment, regardless of the final diagnosis and the location of treatment. Moreover, patients preferred to be referred even if there was only a relatively low probability of having ovarian cancer. Patients' preferences should be taken into account when deciding on optimal cut-offs for risk assessment strategies., Competing Interests: Competing interests: None declared., (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The value of serum human epididymis protein 4 (HE4) in guiding referral decisions in patients with an ovarian mass remains unclear, because the majority of studies investigating HE4 were performed in oncology hospitals. However, the decision to refer is made at general hospitals with a low ovarian cancer prevalence. We assessed accuracies of HE4 in differentiating benign or borderline from malignant tumors in patients presenting with an ovarian mass at general hospitals., Method: Patients with an ovarian mass were prospectively included between 2017 and 2021 in nine general hospitals. HE4 and CA125 were preoperatively measured and the risk of malignancy index (RMI) was calculated. Histological diagnosis was the reference standard., Results: We included 316 patients, of whom 195 had a benign, 39 had a borderline and 82 had a malignant ovarian mass. HE4 had the highest AUC of 0.80 (95%CI 0.74-0.86), followed by RMI (0.71, 95%CI 0.64-0.78) and CA125 (0.69, 95%CI 0.62-0.75). Clinical setting significantly influenced biomarker performances. Applying age-dependent cut-off values for HE4 resulted in a better performance than one cut-off. Addition of HE4 to RMI resulted in a 32% decrease of unnecessary referred patients, while the number of correctly referred patients remained the same., Conclusion: HE4 is superior to RMI in predicting malignancy in patients with an ovarian mass from general hospitals. The addition of HE4 to the RMI improved HE4 alone. Although, there is still room for improvement, HE4 can guide referral decisions in patients with an ovarian mass to an oncology hospital., Competing Interests: Declaration of Competing Interest All authors declare no conflict of interest., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Approximately 80% of the patients undergoing bariatric surgery are female, with half of them undergoing surgery during their reproductive years. Most guidelines recommend that women wait at least 12 months after surgery before becoming pregnant. No previous studies have investigated whether becoming pregnant in the first or second year after surgery affects weight loss., Objectives: The aim of this study was to assess whether pregnancy within the first or second year after bariatric surgery affects weight loss up to 5 years after surgery., Setting: A single institution., Methods: This study is a retrospective study of women who underwent primary bariatric surgery between 2012 and 2016. Weight outcomes were measured until 5 years after surgery. A linear mixed model was used to assess the effect of the time between surgery and conception in groups on the basis of percentage total weight loss., Results: A total of 55 patients undergoing a primary bariatric procedure were included. Forty-seven women underwent a laparoscopic Roux-en-Y gastric bypass (85.5%), and 8 underwent a sleeve gastrectomy (14.5%). The median time between surgery and estimated conception was 22 months (range: 0-51 months). Women who became pregnant between 12 and 24 months after bariatric surgery (n = 18) and women who became pregnant after 24 months (n = 24) had significantly more weight (β = 3.95, P = .020, and β = 4.09, P =.024, respectively) than women who became pregnant within 12 months after bariatric surgery (n = 12)., Conclusion: Our results suggest that pregnancy within 12 months after bariatric surgery negatively affects the long-term weight loss after bariatric surgery., (Copyright © 2022 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)