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Background and aimsThe established standard care in pregnancy is medication for opioid use disorder (MOUD); however, many institutions of incarceration do not have MOUD available. We aimed to describe the number of incarcerated pregnant women with opioid use disorder (OUD) in the United States and jails' and prisons' MOUD in pregnancy policies.DesignEpidemiological surveillance study of 6 months of outcomes of pregnant, incarcerated women with OUD and cross-sectional survey of institutional policies.SettingUnited States.ParticipantsTwenty-two state prison systems and six county jails.MeasurementsThe number of pregnant women with OUD admitted and treated with methadone, buprenorphine or withdrawal; policies on provision of MOUD and withdrawal in pregnancy.FindingsTwenty-six per cent of pregnant women admitted to prisons and 14% to jails had OUD. One-third were managed through withdrawal. The majority who were prescribed MOUD were on methadone (78%, prisons; 81%, jails), not buprenorphine. While most sites (n = 18 prisons, n = four jails) continued pre-incarceration MOUD in pregnancy, very few initiated in custody (n = four prisons; n = two jails). Two-thirds of prisons and three-quarters of jails providing MOUD in pregnancy discontinued it postpartum.ConclusionsIn this sample of US prisons and jails, one-third required pregnant women with opioid use disorder to go through withdrawal, contrary to medical guidelines. More women were prescribed methadone than buprenorphine, despite the fewer regulatory barriers on prescribing buprenorphine. Most sites stopped medication for opioid use disorder postpartum, signaling prioritization of the fetus, not the mother. Pregnant incarcerated women with opioid use disorder in the United States frequently appear to be denied essential medications and receive substandard medical care.

Background Tubal ectopic pregnancies can cause significant morbidity or even death. Current treatment is with methotrexate or surgery. However, methotrexate treatment can fail in approximately 30% of women. Gefitinib, an epidermal growth factor receptor inhibitor, may improve the effects of methotrexate. We assessed the efficacy of administering oral gefitinib with methotrexate, versus methotrexate alone, to treat a tubal ectopic pregnancy. Objectives To test the hypothesis a combination of gefitinib with methotrexate can increase resolution of stable tubal ectopic pregnancy without the need for surgery, compared with methotrexate alone. Design A randomised, double-blind, placebo-controlled, multicentre, superiority trial. Setting Fifty UK hospitals. Participants A target of 328 women with a stable, tubal ectopic pregnancy. Intervention Women were randomised to combination of methotrexate and gefitinib or methotrexate and placebo. All participants received a single intramuscular dose of methotrexate 50 mg/m2 and were randomised in a 1:1 ratio of oral gefitinib (250 mg daily for 7 days) or placebo. Main outcome measures The primary outcome was surgical intervention for resolution of ectopic pregnancy. Secondary outcomes were the need for an additional dose of methotrexate, time to resolution of the ectopic pregnancy, number of treatment-associated hospital visits, safety and tolerability, acceptability of treatment and return to menses. Results Between 2 November 2016 and 6 October 2021, 328 women were randomly allocated to methotrexate and gefitinib (n = 165) or methotrexate and placebo (n = 163). Three women in the placebo group withdrew. Surgical intervention occurred in 30% (50/165) of the gefitinib group and in 29% (47/160) of the placebo group (adjusted risk ratio 1.15, 95% confidence interval 0.85 to 1.58; adjusted risk difference −0.01, 95% confidence interval −0.10 to 0.09; p = 0.37). Without surgical intervention, median time to resolution was 28.0 days in the gefitinib group and 28.0 days in the placebo group (subdistribution hazard ratio 1.03, 95% confidence interval 0.75 to 1.40). The need for additional methotrexate doses, number of additional hospital visits, participant acceptability, time to return of menses and serious adverse events were similar in both groups. Diarrhoea and rash were more common in the gefitinib group. Conclusions The addition of gefitinib to standard medical management with methotrexate to treat tubal ectopic pregnancy is not clinically effective as it does not reduce subsequent surgical intervention and is associated with higher rates of reported symptoms than placebo. Limitations We were unable to investigate how different gefitinib doses or modes of delivery would impact on the results. Future work Questions that remain unaddressed relate to the use of methotrexate and gefitinib combination treatment for other extrauterine and uterine ectopic pregnancy, such as caesarean scar pregnancies, or in the management of choriocarcinoma. Trial registration This trial is registered as ISRCTN 67795930 and EudraCT 2015-005013-76. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme and will be published in full in Efficacy and Mechanistic Evaluation; Vol. 10, No. 1. The gefitinib and placebo were supplied by Astra Zeneca. See the NIHR Journals Library website for further project information. Plain language summary What was the question? A tubal ectopic pregnancy is where a fertilised egg is not growing in the womb. The pregnancy cannot be saved and the woman is at risk of losing her fallopian tube and if this pregnancy is left to grow can even die. Current treatment is with methotrexate or surgery. An operation can happen because either the ectopic pregnancy has ruptured and caused internal bleeding, the medical treatment has not worked and the ectopic pregnancy needs to be removed or the patient can chose to have an operation. However, methotrexate treatment can fail in approximately 30% of women. We carried out research to see if the addition of a new drug (gefitinib, a drug used for lung cancer) to methotrexate could lower the number of women needing an operation to remove their ectopic pregnancy. What did we do? We involved 328 women with a stable tubal ectopic pregnancy, who were being treated medically with methotrexate, and randomly assigned them to have methotrexate alone or a combination of methotrexate and gefitinib. The gefitinib was taken in tablet form for 7 days, and the methotrexate was given as an injection. We followed the women up in line with their clinical care until their ectopic pregnancy resolved or they had surgery to remove the ectopic pregnancy. What did we find? The addition of gefitinib to methotrexate did not reduce the number of women who required surgery to remove their ectopic pregnancy. More women taking gefitinib experienced side effects, such as a facial rash or diarrhoea. What does this mean? Treatment with methotrexate remains the only drug treatment option for ectopic pregnancy. More research is needed. Scientific summary Background Tubal ectopic pregnancy (EP) can cause significant morbidity or even death. Current treatment is with methotrexate (MTX) or surgery. However, MTX treatment can fail in approximately 30% of women. Preclinical studies have shown that tubal implantation sites express high levels of epidermal growth factor receptor (EGFR) and that gefitinib (an EGFR antagonist) augments MTX-induced regression of pregnancy-like tissue. Clinical evidence from uncontrolled phase I and II trials has raised the possibility that a combination of MTX and gefitinib could be a more effective medical treatment than MTX alone to treat stable tubal EP. Objectives To test the hypothesis, a combination of gefitinib with MTX can increase resolution of stable tubal EP without the need for surgery, compared with MTX alone. Design A randomised, double-blind, placebo-controlled, multicentre, superiority trial. Setting This trial took place in 50 hospitals in the UK. Participants A target of 328 women with a stable, tubal EP. Intervention Participants were randomly assigned in a 1:1 ratio to receive either gefitinib and MTX or matched placebo and MTX with the use of minimisation to balance trial-group assignments according to baseline human chorionic gonadotropin levels (

Aim: Acute kidney injury (AKI) after cardiac surgery increases morbidity and mortality. Different definitions for AKI have been used such as Acute Kidney Injury Network (AKIN), Kidney Disease: Improving Global Outcomes (KDIGO) or risk, injury, failure, loss, end‐stage kidney disease (RIFLE). The aim of this study is to determine the best definition of AKI after cardiac surgery with the largest impact on the outcome. Methods: This retrospective study of cardiac surgery patients compared the incidence and effect on outcome (90‐day and 1‐year mortality) of different definitions of AKI: RIFLE, AKIN and KDIGO. Additionally, we defined transient AKI (increase in serum creatinine that resolved in <72 hours), sustained (increase in serum creatinine within 48 hours that remained for >72 hours), and late (increase in serum creatinine after 48 hours). Results: Of the included 1551 patients, 410 patients developed AKI defined by AKIN criteria, 449 defined by KDIGO and 217 defined by RIFLE‐Risk criteria. Hundred and nine patients developed transient AKI (6.9%), 183 patients had sustained AKI (11.6%), and 106 patients had late AKI (6.7%). The best definition with the highest positive likelihood ratio was RIFLE‐Risk (positive likelihood ratio = 2.32) followed by "sustained AKI" (positive likelihood ratio = 2.27). AKI defined by AKIN criteria missed all 80 patients with late AKI and 39 patients with KDIGO AKI. Conclusion: Risk, injury, failure, loss, end‐stage kidney disease‐risk was the best definition of AKI as determined by the ability to predict short‐term mortality. A substantial number of patients developed AKI only after 48 hours, and these were missed when using AKIN criteria. AKIN criteria are not sensitive enough to capture all episodes of AKI in this population. Summary at a glance: This paper compares acute kidney injury scoring systems retrospectively applied to patients undergoing cardiac procedures. It highlights the differences in specificity and sensitivity of these scoring systems for predicting mortality and underscores the deficiencies of relying on a single scoring system to determine risk. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions No clear guidelines exist for perioperative anticoagulation management after durable left ventricular assist device insertion. In this study, we sought to compare outcomes between anti‐factor Xa (FXa) and activated partial thromboplastin time (aPTT) in monitoring unfractionated heparin (UFH) dosing after HeartMate 3 (HM3) insertion.This is a single‐center retrospective review of patients who received UFH after HM3 insertion between 01/2020–12/2022. Post‐operative UFH dose was titrated by aPTT goal 45–60 sec (n = 53) or FXa goal 0.1–0.2 U/mL (n = 59). Baseline differences between cohorts were balanced by inverse probability treatment weighting.At baseline, unadjusted FXa patients were more likely to be white (47.5% vs. 35.8%, p < 0.001), INTERMACS 1–2 (69.5% vs. 47.2%, p = 0.013), have history of coronary artery disease (66.1% vs. 43.4%, p = 0.026), and lower eGFR (54.1 vs. 63.7 mL/min/1.73 m2, p = 0.029) compared to the aPTT group. After adjusting for several bleeding/thrombosis risk factors, 97.5% of FXa and 91.0% of aPTT patients reached therapeutic levels with comparable UFH duration and maximum dose. Moreover, in‐hospital mortality (2.5% vs. 3.1%, p = 0.842), major bleeding events (4.2% vs. 9.2%, p = 0.360), and thromboembolic events (21.8% vs. 10.1%, p = 0.151) remained without significant differences between FXa and aPTT cohorts. There was a high degree of variability in FXa (r2 = 0.20) and aPTT (r2 = 0.22) values for any given UFH dose.No differences in frequency of bleeding or thromboembolic events were observed in this study between FXa versus aPTT cohorts after HM3 implantation. More longitudinal studies are warranted to determine whether or not one assay is superior to the other. [ABSTRACT FROM AUTHOR]