POPPIE : protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth

© 2019 The Author(s). Background: High rates of preterm births remain a UK public health concern. Preterm birth is a major determinant of adverse infant and longer-term outcomes, including survival, quality of life, psychosocial effects on the family and health care costs. We aim to test whether a model of care combining continuity of midwife care with rapid referral to a specialist obstetric clinic throughout pregnancy, intrapartum and the postpartum period is feasible and improves experience and outcomes for women at increased risk of preterm birth. Methods: This pilot, hybrid, type 2 randomised controlled implementation trial will recruit 350 pregnant women at increased risk of preterm birth to a midwifery continuity of care intervention or standard care. The intervention will be provided from recruitment (antenatal), labour, birth and the postnatal period, in hospital and community settings and in collaboration with specialist obstetric clinic care, when required. Standard care will be the current maternity care provision by NHS midwives and obstetricians at the study site. Participants will be followed up until 6-8 weeks postpartum. The composite primary outcome is the appropriate initiation of any specified interventions related to the prevention and/or management of preterm labour and birth. Secondary outcomes are related to: recruitment and attrition rates; implementation; acceptability to women, health care professionals and stakeholders; health in pregnancy and other complications; intrapartum outcomes; maternal and neonatal postnatal outcomes; psycho-social health; quality of care; women's experiences and health economic analysis. The trial has 80% power to detect a 15% increase in the rate of appropriate interventions (40 to 55%). The analysis will be by 'intention to treat' analysis. Discussion: Little is known about the underlying reasons why and how models of midwifery continuity of care are associated with fewer preterm births, better maternal and infant outcomes and more positive experiences; nor how these models of care can be implemented successfully in the health services. This will be the first study to provide direct evidence regarding the effectiveness, implementation and evaluation of a midwifery continuity of care model and rapid access to specialist obstetric services for women at increased risk of preterm birth. Trial registration: ISRCTN37733900. Retrospectively registered on 21 August 2017

A long-period transiting substellar companion in the super-Jupiters to brown dwarfs mass regime and a prototypical warm-Jupiter detected by TESS

We report on the confirmation and follow-up characterization of two long-period transiting substellar companions on low-eccentricity orbits around TIC 4672985 and TOI-2529, whose transit events were detected by the TESS space mission. Ground-based photometric and spectroscopic follow up from different facilities, confirmed the substellar nature of TIC 4672985 b, a massive gas giant, in the transition between the super-Jupiters and brown-dwarfs mass regime. From the joint analysis we derived the following orbital parameters: P = 69.0480+0.0004−0.0005 d, Mp = 12.74+1.01−1.01 MJ, Rp =1.026+0.065−0.067 RJ and e = 0.018+0.004−0.004 . In addition, the RV time series revealed a significant trend at the ∼ 350 m s−1 yr−1level, which is indicative of the presence of a massive outer companion in the system. TIC 4672985 b is a unique example of a transiting substellar companion with a mass above the deuterium-burning limit, located beyond 0.1 AU and in a nearly circular orbit. These planetary properties are difficult to reproduce from canonical planet formation and evolution models. For TOI-2529 b, we obtained the following orbital parameters: P = 64.5949+0.0003−0.0003 d, Mp =2.340+0.197−0.195 MJ, Rp = 1.030+0.050−0.050 RJ and e = 0.021+0.024−0.015 , making this object a new example of a growing population of transiting warm giant planets

The age and origin of groundwater in the Great Western Erg sub-basin of the North-Western Sahara aquifer system: insights from Krechba, central Algeria

Abstract: The North-Western Sahara aquifer system (NWSAS) forms an important transboundary groundwater resource whose properties remain to be fully understood across its whole extent. For example, groundwater flow in the Cretaceous Continental Intercalaire (CI) unit of the NWSAS is well-characterised in the northern part of its range around the Algeria/Tunisia/Libya borders and in the Great Eastern Erg sub-basin immediately to the south. To the southwest, however, the CI of the Great Western Erg sub-basin has been much less studied. The present paper reports hydrogeochemical data from a wellfield in central Algeria which will contribute to a better understanding of this sector of the NWSAS in terms of the age and origin of groundwater within it. Groundwater pumped from five deep boreholes in the CI aquifer overlying the Krechba gas field has been studied using a variety of environmental tracers including hydrochemistry, environmental isotopes, and reactive and noble gases (the latter being reported for the first time for this sub-basin). All the waters were dilute (SEC 460–600 µS/cm), contained detectable O2 (6.3–7.5 mg/L), showed evidence of evaporation (relative enrichment in δ18O), gave late-Pleistocene 14C model ages (13.5–19.3 ka), and yielded lower than present-day noble gas recharge temperatures (14.3–17.6°C). Various lines of evidence suggest that these waters are the product of mixing between water recharged direct to the CI and leakage from the Neogene–Quaternary Erg aquifer. The results support the long-held concept of regional flow from a palaeo-recharge area to the northwest. Finally, while the Krechba gas field (Carboniferous) has been since 2004 the site of a pilot carbon capture and storage (CCS) project, the data revealed no evidence for leakage of fluids (gas or brines) into the overlying CI aquifer at the time of sampling (October 2014)

Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation–effectiveness, randomised controlled pilot trial in the UK

Background Midwifery continuity of care is the only health system intervention shown to reduce preterm birth (PTB) and improve perinatal survival, but no trial evidence exists for women with identified risk factors for PTB. We aimed to assess feasibility, fidelity, and clinical outcomes of a model of midwifery continuity of care linked with a specialist obstetric clinic for women considered at increased risk for PTB. Methods and findings We conducted a hybrid implementation–effectiveness, randomised, controlled, unblinded, parallel-group pilot trial at an inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB were randomly assigned (1:1) to either midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women’s Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas). Pregnant women attending for antenatal care at less than 24 weeks’ gestation were eligible if they fulfilled one or more of the following criteria: previous cervical surgery, cerclage, premature rupture of membranes, PTB, or late miscarriage; previous short cervix or short cervix this pregnancy; or uterine abnormality and/or current smoker of tobacco. Feasibility outcomes included eligibility, recruitment and attrition rates, and fidelity of the model. The primary outcome was a composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth. We analysed by intention to treat. Between 9 May 2017 and 30 September 2018, 334 women were recruited; 169 women were allocated to the POPPIE group and 165 to the standard group. Mean maternal age was 31 years; 32% of the women were from Black, Asian, and ethnic minority groups; 70% were in employment; and 46% had a university degree. Nearly 70% of women lived in areas of social deprivation. More than a quarter of women had at least one pre-existing medical condition and multiple risk factors for PTB. More than 75% of antenatal and postnatal visits were provided by a named/partner midwife, and a midwife from the POPPIE team was present at 80% of births. The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742). Infants in the POPPIE group were significantly more likely to have skin-to-skin contact after birth, to have it for a longer time, and to breastfeed immediately after birth and at hospital discharge. There were no differences in other secondary outcomes. The number of serious adverse events was similar in both groups and unrelated to the intervention (POPPIE group 6 versus standard group 5). Limitations of this study included the limited power and the nonmasking of group allocation; however, study assignment was masked to the statistician and researchers who analysed the data. Conclusions In this study, we found that it is feasible to set up and achieve fidelity of a model of midwifery continuity of care linked with specialist obstetric care for women at increased risk of PTB in an inner-city maternity service in London (UK), but there is no impact on most outcomes for this population group. Larger appropriately powered trials are needed, including in other settings, to evaluate the impact of relational continuity and hypothesised mechanisms of effect based on increased trust and engagement, improved care coordination, and earlier referral on disadvantaged communities, including women with complex social factors and social vulnerability. Trial registration We prospectively registered the pilot trial on the UK Clinical Research Network Portfolio Database (ID number: 31951, 24 April 2017). We registered the trial on the International Standard Randomised Controlled Trial Number (ISRCTN) (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE). The protocol as registered and published has remained unchanged, and the analysis conforms to the original plan

Rare Skin Adnexal and Melanocytic Tumors Arising in Ovarian Mature Cystic Teratomas: A Report of 3 Cases and Review of the Literature

Mature teratoma of the ovary is the most common primary ovarian tumor accounting for 15% (10%–20%) of all ovarian neoplasms. Skin and skin adnexal structures are the most common elements identified in mature teratomas. Benign and malignant skin tumors can arise in ovarian teratomas, the most common being epithelial tumors. Melanocytic and adnexal tumors developing in a teratoma are rare and can be easily overlooked. We report 3 cases and review melanocytic and skin adnexal tumors encountered in ovarian teratomas

Measuring precise radial velocities on individual spectral lines. III. Dependence of stellar activity signal on line formation temperature

Context. To enable radial velocity (RV) precision on the order of ~0.1 m/s required for the detection of Earth-like exoplanets orbiting solar-type stars, the main obstacle lies in mitigating the impact of stellar activity. Aims. This study investigates the dependence of derived RVs with respect to the formation temperature of spectral line segments. Methods. Using spectral synthesis, we compute for each observed wavelength point of unblended spectral lines the stellar temperature below which 50% of the emergent flux originates. We can then construct RV time series for different temperature ranges, using template matching. Results. With HARPS-N solar data and HARPS $\alpha$ Cen B measurements, we demonstrate on time intervals of prominent stellar activity that the activity-induced RV signal has different amplitude and periodicity depending on the temperature range considered. We compare the solar measurements with simulated contributions from active surface regions seen in simultaneous images, and find that the suppression of convective motion is the dominant effect. Conclusions. From a carefully selected set of spectral lines, we are able to measure the RV impact of stellar activity at various stellar temperatures ranges. We are able to strongly correlate the effect of convective suppression with spectral line segments formed in hotter temperature ranges. At cooler temperatures, the derived RVs exhibit oppositely directed variations compared to the average RV time series and stronger anti-correlations with chromospheric emission.Comment: Accepted for publication in A&

Two cases of large retroperitoneal schwannoma treated with minimally invasive surgery. Role of the gynecologic oncologist

Background. Schwannomas are neurogenic tumors originating in the Schwann cells of the nerve sheath. Methods. This paper describes two consecutive cases of retroperitoneal pelvic schwannomas and review the current understanding and management in this unusual location by a team of gynecologist oncologists. Results. Minimally invasive surgical removal of retroperitoneal schwannomas is feasible, surgeons and patients must be aware of the possible early and long term collaterals. Conclusion. Gynecologist oncologists are the professional figure who is perhaps best placed for removing lumps from the retroperitoneal space because of familiarity with the structures involved in the dissection. We describe the challenges involved in preoperative diagnosis and minimally invasive management

Measuring precise radial velocities on individual spectral lines

Context. To enable radial velocity (RV) precision on the order of ~0.1 m s−1 required for the detection of Earth-like exoplanets orbiting solar-type stars, the main obstacle lies in mitigating the impact of stellar activity. Aims. This study investigates the dependence of derived RVs with respect to the formation temperature of spectral line segments. Methods. Using spectral synthesis, we computed the stellar temperature below which 50% of the emergent flux originates for each observed wavelength point of unblended spectral lines. We then constructed RV time series for different temperature ranges using template matching. Results. With HARPS-N solar data and HARPS α Cen B measurements, we demonstrate on time intervals of prominent stellar activity that the activity-induced RV signal has different amplitude and periodicity depending on the temperature range considered. We compare the solar measurements with simulated contributions from active surface regions seen in simultaneous images, and find that the suppression of convective motion is the dominant effect. Conclusions. From a carefully selected set of spectral lines, we are able to measure the RV impact of stellar activity at various stellar temperatures ranges. We are able to strongly correlate the effect of convective suppression with spectral line segments formed in hotter temperature ranges. At cooler temperatures, the derived RVs exhibit oppositely directed variations compared to the average RV time series and stronger anticorrelations with chromospheric emission

Laparoscopic conversion of omega loop gastric bypass to Roux-en-Y gastric bypass for Barrett’s esophagus: case report

Abstract Background The number of mini gastric bypass / one anastomosis bypass (MGB-OAGB) procedures in bariatric patients that have been performed world-wide has drastically increased during the past decade. Nevertheless, due to the risk of subsequent biliary reflux and development of ulcer and neoplastic (pre)lesions caused by long-time bile exposure, the procedure is still controversially discussed. In here presented case report, we could endoscopically demonstrate a transformation from reflux oesophagitis to Barrett’s metaplasia most likely caused by bile reflux after mini-gastric bypass. To our knowledge, this is a first case study that shows development of Barrett’s metaplasia after MGB-OAGB. Case presentation We present the case of a 50-year-old female which received a mini-gastric bypass due to morbid obesity (body mass index (BMI) 42.4 kg/m2). Because of history gastroesophageal reflux disease (GERD), a fundoplication had been performed earlier. Preoperative gastroscopy showed reflux esophagitis (Los Angeles classification grade B) with no signs of Barrett’s metaplasia. Three months post mini-gastric bypass, the patient complained about severe bile reflux under 40 mg pantoprazole daily. Six months postoperative, Endoscopically Barrett’s epithelium was detected and histopathologically confirmed (C1M0 after Prague classification). A conversion into Roux-en-Y gastric bypass was performed. The postoperative course was without complications. In a follow up after 6 months the patient denied reflux and showed no signs of malnutrition. Conclusions The rapid progress from inflammatory changes of the distal esophagus towards Barrett’s metaplasia under bile reflux in our case is most likely a result of previous reflux disease. Nevertheless, bile reflux appears to be a potential decisive factor. Study results regarding presence of bile reflux or development of endoscopically de-novo findings after MGB-OAGB are widely non-conclusive. Long-term prospective studies with regular endoscopic surveillance independent of clinical symptoms are needed

Metabolic effects of the waist-to-hip ratio associated locus <em>GRB14/COBLL1 </em>are related to <em>GRB14</em> expression in adipose tissue.

GRB14/COBLL1 locus has been shown to be associated with body fat distribution (FD), but neither the causal gene nor its role in metabolic diseases has been elucidated. We hypothesize that GRB14/COBLL1 may act as the causal genes for FD-related SNPs (rs10195252 and rs6738627), and that they may be regulated by SNP to effect obesity-related metabolic traits. We genotyped rs10195252 and rs6738627 in 2860 subjects with metabolic phenotypes. In a subgroup of 560 subjects, we analyzed GRB14/COBLL1 gene expression in paired visceral and subcutaneous adipose tissue (AT) samples. Mediation analyses were used to determine the causal relationship between SNPs, AT GRB14/COBLL1 mRNA expression, and obesity-related traits. In vitro gene knockdown of Grb14/Cobll1 was used to test their role in adipogenesis. Both gene expressions in AT are correlated with waist circumference. Visceral GRB14 mRNA expression is associated with FPG and HbA1c. Both SNPs are associated with triglycerides, FPG, and leptin levels. Rs10195252 is associated with HbA1c and seems to be mediated by visceral AT GRB14 mRNA expression. Our data support the role of the GRB14/COBLL1 gene expression in body FD and its locus in metabolic sequelae: in particular, lipid metabolism and glucose homeostasis, which is likely mediated by AT GRB14 transcript levels