Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from 2 randomized, placebo-controlled studies.

BACKGROUND: Slow progression of labor is a common obstetrical problem with multiple associated complications. Tafoxiparin is a depolymerized form of heparin with a molecular structure that eliminates the anticoagulant effects of heparin. We report on 2 phase II clinical studies of tafoxiparin in primiparas. Study 1 was an exploratory, first-in-pregnant-women study and study 2 was a dose-finding study. OBJECTIVE: Study 1 was performed to explore the effects on labor time of subcutaneous administration of tafoxiparin before onset of labor. Study 2 was performed to test the hypothesis that intravenous treatment with tafoxiparin reduces the risk for prolonged labor after spontaneous labor onset in situations requiring oxytocin stimulation because of dystocia. STUDY DESIGN: Both studies were randomized, double-blind, and placebo-controlled. Participants were healthy, nulliparous females aged 18 to 45 years with a normal singleton pregnancy and gestational age confirmed by ultrasound. The primary endpoints were time from onset of established labor (cervical dilation of 4 cm) until delivery (study 1) and time from start of study treatment infusion until delivery (study 2). In study 1, patients at 38 to 40 weeks of gestation received 60 mg tafoxiparin or placebo daily as 0.4 mL subcutaneous injections until labor onset (maximum 28 days). In study 2, patients experiencing slow progression of labor, a prolonged latent phase, or labor arrest received a placebo or 1 of 3 short-term tafoxiparin regimens (initial bolus 7, 21, or 35 mg followed by continuous infusion at 5, 15, or 25 mg/hour until delivery; maximum duration, 36 hours) in conjunction with oxytocin. RESULTS: The number of participants randomized in study 1 was 263, and 361 were randomized in study 2. There were no statistically significant differences in the primary endpoints between those receiving tafoxiparin and those receiving the placebo in both studies. However, in study 1, the risk for having a labor time exceeding 12 hours was significantly reduced by tafoxiparin (tafoxiparin 6/114 [5%] vs placebo 18/101 [18%]; P=.0045). Post hoc analyses showed that women who underwent labor induction had a median (range) labor time of 4.44 (1.2-8.5) hours with tafoxiparin and 7.03 (1.5-14.3) hours with the placebo (P=.0041) and that co-administration of tafoxiparin potentiates the effect of oxytocin and facilitates a shorter labor time among women with a labor time exceeding 6 to 8 hours (P=.016). Among women induced into labor, tafoxiparin had a positive effect on cervical ripening in 11 of 13 cases (85%) compared with 3 of 13 participants (23%) who received the placebo (P=.004). For women requiring oxytocin because of slow progression of labor, the corresponding results were 34 of 51 participants (66%) vs 16 of 40 participants (40%) (P=.004). In study 2, tafoxiparin had no positive effects on the secondary endpoints when compared with the placebo. Except for injection-site reactions in study 1, adverse events were no more common for tafoxiparin than for the placebo among either mothers or infants. There were few serious or treatment-related adverse events. CONCLUSION: Subcutaneous treatment with tafoxiparin before labor onset (study 1) may be effective in reducing the labor time among women undergoing labor induction and among those requiring oxytocin for slow progression of labor. Moreover, tafoxiparin may have a positive effect on cervical ripening. Short-term, intravenous treatment with tafoxiparin as an adjunct to oxytocin in patients with labor arrest (study 2) did not affect labor time or other endpoints. Both studies suggest that tafoxiparin has a favorable safety profile in mothers and their infants.

Facilitating planned home death: A qualitative study on home care nurses' experiences of enablers and barriers.

AIM: The aim of this study was to explore home care nurses' experience of enablers and barriers for planned home death in municipal health care. DESIGN: A focused ethnography. METHODS: This qualitative study collected data from 20 semi-structured interviews of home care nurses and 8.5 h of participant observations. Data was analyzed using thematic analysis. RESULTS: The findings in our study show that home care nurses consider supportive cultures, a commitment to safety and continuity when facilitating planned home deaths and family rotations to be enablers for planned home deaths. Barriers to planned home deaths involve a lack of palliative experience affecting confidence, shortages of nurses and medical supplies and night shift challenges. CONCLUSION: This study underscores the need for supportive organizational cultures, ongoing education and improved communication and staffing policies to enhance the quality of care and the experiences of patients and home care nurses, especially in the context of planned home deaths. IMPACT: The study adds knowledge to the evidence base of the practice of facilitating planned home deaths. The findings of the study could offer valuable insights for shaping future policies or devising effective implementation strategies. REPORTING METHOD: Adherence to the COREQ guidelines for reporting qualitative research was maintained. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution. WHAT DOES THIS ARTICLE CONTRIBUTE TO THE WIDER GLOBAL CLINICAL COMMUNITY?: Identified enablers and barriers provide a new perspective, contributing to a comprehensive understanding of planning home deaths. The study emphasizes supportive cultures, safety commitment and family rotations as crucial for planned home deaths, guiding healthcare professionals to adopt best practices and enhance palliative care quality.

Adapting to home care in Norway: A longitudinal case study of older Adults' experiences.

This study aimed to describe how older adults with complex health problems manage their everyday lives in their own homes and how they interact with given home care. In this multiple-case study, a total of 14 individual interviews were conducted with five older adults over the course of one year. Deductive and inductive content analyses were performed. Three descriptive categories were each identified in the deductive ('home care as interpersonal continuity', 'home care as information continuity' and 'home care as management continuity') and inductive analyses ('Lack of social contact with carers', 'Desire to be heard throughout the care process' and 'Carers are short on time'). Quality home care services are difficult to realize if interpersonal interaction is subordinated to effective task-solving.