| 1. |
- Ekman-Ordeberg, Gunvor, et al.
(författare)
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Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from 2 randomized, placebo-controlled studies
- 2024
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Ingår i: American Journal of Obstetrics and Gynecology. - 0002-9378 .- 1097-6868. ; 230:3
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Forskningsöversikt (refereegranskat)abstract
- 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.
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| 2. |
- Engberg, Jan, 1950-, et al.
(författare)
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Outsourced responsibilities and new public management : the context of Swedish crisis management as seen from county administration boards
- 2015
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Ingår i: International Journal of Mass Emergencies and Disasters. - : International Research Committee on Disasters. - 0280-7270. ; 33:3, s. 323-339
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Tidskriftsartikel (refereegranskat)abstract
- In this article, a storm named Hilde is the entry point for an exploration and analysis of the consequences of public sector reforms on the crisis management system in Sweden. We are particularly interested in reforms of decentralization, privatization, and the adoption of New Public Management (NPM) mechanisms. Empirically, we study the views of Civil Defence Directors at County Administration Boards (CABs). The 21 CABs represent the central government at the regional level and are required by law to coordinate crisis management between national agencies, municipalities, and private interests. Our empirical investigations indicate that the Defence Directors perceive and adapt to reforms differently depending on the size of CABs, thereby bringing to the fore critical matters of equivalence. It also appears as if the discretion that the reforms were supposed to provide for crisis management actors is severely hampered by NPM inspired regulations, competitive features, and instruments of control.
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| 3. |
- Naarttijärvi, Markus, 1981-, et al.
(författare)
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Krisen, myndigheterna och lagen : Krishantering i rättens gränsland
- 2015
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Bok (refereegranskat)abstract
- Vid kriser som Estoniakatastrofen, tsunamin eller skogsbranden i Västmanland måste myndigheter kunna agera snabbt och effektivt tillsammans. Men detta måste ske utan att lagar överträds och utan att principerna för rättsstaten bryts, något som kan vara utmanande. Dessutom bygger vår krisberedskap i stort på principer och målsättningar som saknar ett bestämt juridiskt innehåll, till exempel ansvars- och närhetsprincipen, och på förhoppningar om att myndigheter och andra offentliga och privata aktörer övat samverkan och förmår komma överens.I denna bok utreds de rättsliga förutsättningarna för krishantering. Därtill ställs frågan hur detta sätt att reglera och styra agerandet i krissituationer faktiskt upplevs av de aktörer som är berörda. Förstår de vad som förväntas, tycker de att detta är genomförbart och uppfattar de var de rättsliga gränserna går?I boken diskuteras också om denna regleringsform gett upphov till oväntade gränsdragningsproblem och principiella konflikter i styrningen, och hur dessa i så fall förhåller sig till etablerade rättsstatliga principer om bland annat klarhet, koherens, rimlighet och kongruens.
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| 4. |
- Wimelius E., Malin, 1972-, et al.
(författare)
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Crisis Management through Network Coordination : Experiences of Swedish Civil Defence Directors
- 2015
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Ingår i: Journal of Contingencies and Crisis Management. - : Wiley. - 0966-0879 .- 1468-5973. ; 23:3, s. 129-137
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Tidskriftsartikel (refereegranskat)abstract
- In this article we explore and analyse Swedish Civil Defence Directors’ views on coordination and cooperation in crisis management. The directors work at County Administrative Boards (CABs) which by law are required to coordinate all relevant actors – national agencies, municipal, private and voluntary – by leading their cooperation in extraordinary events. How do CABs manage this, especially against a backdrop of increasing demands on clarity, command, control and explicit goals in crisis management? Through the lens of research on governance we analyse the directors’ views and find that although they support horizontal, inter-organizational network based coordination and cooperation, there is frustration regarding the decision-making capacities of the CABs, the lack of conflict management mechanisms in networks and resource allocation.
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