A core outcome set for trials in miscarriage management and prevention: an international consensus development study.

OBJECTIVE: To develop core outcome sets (COS) for miscarriage management and prevention. DESIGN: Modified Delphi survey combined with a consensus development meeting. SETTING: International. POPULATION: Stakeholder groups included healthcare providers, international experts, researchers, charities and couples with lived experience of miscarriage from 15 countries: 129 stakeholders for miscarriage management and 437 for miscarriage prevention. METHODS: Modified Delphi method and modified nominal group technique. RESULTS: The final COS for miscarriage management comprises six outcomes: efficacy of treatment, heavy vaginal bleeding, pelvic infection, maternal death, treatment or procedure-related complications, and patient satisfaction. The final COS for miscarriage prevention comprises 12 outcomes: pregnancy loss <24 weeks' gestation, live birth, gestation at birth, pre-term birth, congenital abnormalities, fetal growth restriction, maternal (antenatal) complications, compliance with intervention, patient satisfaction, maternal hospitalisation, neonatal or infant hospitalisation, and neonatal or infant death. Other outcomes identified as important were mental health-related outcomes, future fertility and health economic outcomes. CONCLUSIONS: This study has developed two core outcome sets, through robust methodology, that should be implemented across future randomised trials and systematic reviews in miscarriage management and prevention. This work will help to standardise outcome selection, collection and reporting, and improve the quality and safety of future studies in miscarriage

Shotgun Proteomics Identifies Serum Fibronectin as a Candidate Diagnostic Biomarker for Inclusion in Future Multiplex Tests for Ectopic Pregnancy

Ectopic pregnancy (EP) is difficult to diagnose early and accurately. Women often present at emergency departments in early pregnancy with a 'pregnancy of unknown location' (PUL), and diagnosis and exclusion of EP is challenging due to a lack of reliable biomarkers. The objective of this study was to identify novel diagnostic biomarkers for EP. Shotgun proteomics, incorporating combinatorial-ligand library pre-fractionation, was used to interrogate pooled sera (n = 40) from women undergoing surgery for EP, termination of viable intrauterine pregnancy and management of non-viable intrauterine pregnancy. Western blot was used to validate results in individual sera. ELISAs were developed to interrogate sera from women with PUL (n = 120). Sera were collected at time of first symptomatic presentation and categorized according to pregnancy outcome. The main outcome measures were differences between groups and area under the receiver operating curve (ROC). Proteomics identified six biomarker candidates. Western blot detected significant differences in levels of two of these candidates. ELISA of sera from second cohort revealed that these differences were only significant for one of these candidates, fibronectin. ROC analysis of ability of fibronectin to discriminate EP from other pregnancy outcomes suggested that fibronectin has diagnostic potential (ROC 0.6439; 95% CI 0.5090 to 0.7788; P>0.05), becoming significant when 'ambiguous' medically managed PUL excluded from analysis (ROC 0.6538; 95% CI 0.5158 to 0.7918; P<0.05). Fibronectin may make a useful adjunct to future multiplex EP diagnostic tests

Can we predict shortened or prolonged gestation upon transfer to the farrowing shed?

Application Results from this research could provide an opportunity to predict shortened or prolonged gestation, which both have direct implications for health, welfare and productivity of both sows and piglets. Introduction Farrowing is the most critical period for the survival of both sows and piglets. Farrowing is considered successful if completed within 5 h, with more than 90% of born alive piglets surviving the following 72 h, otherwise there is increased risk of stillborns, higher pre-weaning mortality or health implications for the sow (Peltoniemi and Oliviero, 2015). A better understanding of the timing of farrowing could help to allocate labour to increase observation during the critical days and therefore improve farrowing results (Peltoniemi and Oliviero, 2015). Preliminary analyses showed that approximately 92% of sows farrowed within 2 d of the expected date, but there was no improvement in overall prediction capacity from observing other factors. This study tested the hypothesis that individual observations for sows upon the transfer to the farrowing shed could be used to better predict either shortened or prolonged gestations

Ultrasound evaluation of pouch of Douglas obliteration and rectal deep endometriosis in women who have had previous combined colorectal and gynaecological laparoscopic surgery for rectal endometriosis: A pilot study

Background: Ultrasound has been demonstrated to accurately diagnose rectal deep endometriosis (DE) and pouch of Douglas (POD) obliteration. The role of ultrasound in the assessment of patients who have undergone surgery for rectal DE and POD obliteration has not been evaluated. Aim: To describe the transvaginal ultrasound (TVS) findings of patients who have undergone rectal surgery for DE. Materials and Methods: An observational cross-sectional study at a tertiary care centre in Sydney, Australia between January and April 2017. Patients previously treated for rectal DE (low anterior resection vs rectal shaving/disc excision) were recruited and asked to complete a questionnaire on their current symptoms. On TVS, POD state and rectal DE were assessed. Correlating recurrence of POD obliteration and/or rectal DE to surgery type and symptoms was done. Results: Fifty-six patients were contacted; 22/56 (39.3%) attended for the study visit. Average interval of surgery to study visit was 52.8 ± 24.6 months. Surgery type breakdown was as follows: low anterior resection (56%) and rectal shaving/disc excision (44%). The prevalence of POD obliteration was 16/22 (72.7%) intraoperatively and 8/22 (36.4%) at study visit, as per the sliding sign. Nine patients (39.1%) had evidence on TVS of recurrent rectal DE. Recurrence of POD obliteration and rectal DE was not associated with surgery type or symptomatology. Conclusion: Despite surgery for rectal DE, many patients have a negative sliding sign on TVS, representing POD obliteration, and rectal DE. Our numbers are too small to correlate with the surgery type or their current symptoms

Reducing sow confinement during farrowing and in early lactation increases piglet mortality1

The aim of this study was to investigate the effect of sow confinement and nonconfinement during parturition and early lactation on the performance of sows and piglets prior to weaning. Sows and their litters were housed in either a conventional farrowing crate (control; 1.7 × 2.4 m) or a swing-sided pen (2.8 × 2.15 m). Sows housed in the swing-sided pen had the crate open (open) or closed (closed) during farrowing and opened on d 3 (LAC3) or 7 (LAC7) of lactation. Data are means ± SEM. The numbers of total and liveborn piglets were not different between treatments and averaged 13.1 ± 0.4 and 12.3 ± 0.2 piglets/litter, respectively. Sows housed in a farrowing crate had a greater (P = 0.03) number of stillborn piglets compared with open sows from pens (1.1 ± 0.2 vs. 0.6 ± 0.1 piglets/ litter, respectively). Live-born piglet mortality before litter equalization on d 1 was greater (P 0.05). Total live-born piglet mortality from birth until weaning for the control, closedLAC7, closedLAC3, openLAC7, and openLAC3 was 1.86 ± 0.19, 1.95 ± 0.23, 2.10 ± 0.39, 2.45 ± 0.27, and 3.74 ± 0.48, piglets/litter, respectively. Total live-born piglet mortality from birth until weaning was greater in the openLAC3 and openLAC7 treatments compared to control (P < 0.01), and openLAC3 was also greater than openLAC7, closedLAC3, and closedLAC7 (P < 0.01). The current data indicated that reducing sow confinement during parturition decreased stillborn number but increased live-born piglet mortality compared to a farrowing crate, and removing confinement on d 3 of lactation further increased total piglet mortality compared to removing sow confinement on d 7 of lactation in sows that farrowed open. Sows that were confined during farrowing and until d 3 or 7 of lactation in a swing-sided pen had a similar piglet mortality compared to those in a farrowing crate

Ultrasound evaluation of pouch of Douglas obliteration and rectal deep endometriosis in women who have had previous combined colorectal and gynaecological laparoscopic surgery for rectal endometriosis: A pilot study

Background: Ultrasound has been demonstrated to accurately diagnose rectal deep endometriosis (DE) and pouch of Douglas (POD) obliteration. The role of ultrasound in the assessment of patients who have undergone surgery for rectal DE and POD obliteration has not been evaluated. Aim: To describe the transvaginal ultrasound (TVS) findings of patients who have undergone rectal surgery for DE. Materials and Methods: An observational cross-sectional study at a tertiary care centre in Sydney, Australia between January and April 2017. Patients previously treated for rectal DE (low anterior resection vs rectal shaving/disc excision) were recruited and asked to complete a questionnaire on their current symptoms. On TVS, POD state and rectal DE were assessed. Correlating recurrence of POD obliteration and/or rectal DE to surgery type and symptoms was done. Results: Fifty-six patients were contacted; 22/56 (39.3%) attended for the study visit. Average interval of surgery to study visit was 52.8 ± 24.6 months. Surgery type breakdown was as follows: low anterior resection (56%) and rectal shaving/disc excision (44%). The prevalence of POD obliteration was 16/22 (72.7%) intraoperatively and 8/22 (36.4%) at study visit, as per the sliding sign. Nine patients (39.1%) had evidence on TVS of recurrent rectal DE. Recurrence of POD obliteration and rectal DE was not associated with surgery type or symptomatology. Conclusion: Despite surgery for rectal DE, many patients have a negative sliding sign on TVS, representing POD obliteration, and rectal DE. Our numbers are too small to correlate with the surgery type or their current symptoms

NICE guidance on ectopic pregnancy and miscarriage restricts access and choice and may be clinically unsafe

LetterTom Bourne, Kurt Barnhart, Carol B Benson, Jan Brosens, Ben Van Calster, George Condous, Arri Coomerasamy, Peter M Doubilet, Steven R Goldstein, Deborah Gould, Emma Kirk, Ben Willem Mol, Nicholas Raine-Fenning, Catriona Stalder, Dirk Timmerma

Prediction of Tubal Ectopic Pregnancy Using Offline Analysis of 3-Dimensional Transvaginal Ultrasonographic Data Sets: An Interobserver and Diagnostic Accuracy Study

Objectives To assess interobserver reproducibility in detecting tubal ectopic pregnancies by reading data sets from 3\u2010dimensional (3D) transvaginal ultrasonography (TVUS) and comparing it with real\u2010time 2\u2010dimensional (2D) TVUS. Methods Images were initially classified as showing pregnancies of unknown location or tubal ectopic pregnancies on real time 2D TVUS by an experienced sonologist, who acquired 5 3D volumes. Data sets were analyzed offline by 5 observers who had to classify each case as ectopic pregnancy or pregnancy of unknown location. The interobserver reproducibility was evaluated by the Fleiss \u3ba statistic. The performance of each observer in predicting ectopic pregnancies was compared to that of the experienced sonologist. Women were followed until they were reclassified as follows: (1) failed pregnancy of unknown location; (2) intrauterine pregnancy; (3) ectopic pregnancy; or (4) persistent pregnancy of unknown location. Results Sixty\u2010one women were included. The agreement between reading offline 3D data sets and the first real\u2010time 2D TVUS was very good (80%\u201382%; \u3ba\u2009=\u20090.89). The overall interobserver agreement among observers reading offline 3D data sets was moderate (\u3ba\u2009=\u20090.52). The diagnostic performance of experienced observers reading offline 3D data sets had accuracy of 78.3% to 85.0%, sensitivity of 66.7% to 81.3%, specificity of 79.5% to 88.4%, positive predictive value of 57.1% to 72.2%, and negative predictive value of 87.5% to 91.3%, compared to the experienced sonologist's real\u2010time 2D TVUS: accuracy of 94.5%, sensitivity of 94.4%, specificity of 94.5%, positive predictive value of 85.0%, and negative predictive value of 98.1%. Conclusions The diagnostic accuracy of 3D TVUS by reading offline data sets for predicting ectopic pregnancies is dependent on experience. Reading only static 3D data sets without clinical information does not match the diagnostic performance of real time 2D TVUS combined with clinical information obtained during the scan