Vastervik

Researchers are evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organizations Labour Care Guide LCG with standard delivery care in Sweden. The goal is to see if using the LCG can reduce adverse neonatal outcomes and lower the rate of intrapartum Cesarean sections. This study uses a multicenter, stepped-wedge cluster randomized design to explore these effects along with economic considerations and experiences related to childbirth. Participants will receive labor monitoring either according to the WHOs LCG guidelines or standard care. The study will involve multiple delivery units in Sweden, and women in active labor will be randomly assigned to either group as the new guidelines are gradually introduced. Alongside the main study periods, researchers will examine perinatal interventions, labor complications, and collect qualitative data through questionnaires, focus groups, and interviews with women, their partners, and healthcare providers. During participation, women and their partners will be asked about their childbirth experiences, while providers compliance and views on using the LCG will also be assessed. The study will track outcomes such as perinatal mortality, neonatal morbidity, cesarean section rates, and obstetric events like postpartum hemorrhage and labor duration. Data collection and follow-up will occur from 12 weeks up to 18 months after delivery, including economic evaluations and provider experiences to fully understand the effects of the labor monitoring methods.

This research aims to determine if hip replacement surgery arthroplasty can reduce the need for additional operations compared to internal fixation in elderly patients with an undisplaced femoral neck fracture. Patients aged 75 years and older with this type of fracture will be included and randomly assigned to one of two treatments through the Swedish Fracture Register platform. The study focuses on combining reoperation rates and mortality into a single main outcome measure to evaluate which treatment offers better results. Participants will receive either arthroplasty, which may be hemi or total hip replacement depending on the patients condition and surgeons decision, or internal fixation using screws, pins, or a sliding hip screw device based on hospital routine. The study is a randomized controlled trial without blinding, comparing these two device-based treatments for hip fractures in elderly patients. During the study, researchers will monitor the combined rate of reoperations and mortality for 1 to 2 years after surgery. Additional outcomes include reoperation rates, short- and long-term mortality, and patient-reported physical function one year after surgery. Participants will be followed up to assess these outcomes, with care taken to track their progress and safety over the study period.

Researchers are evaluating the effect of spironolactone combined with standard care compared to standard care alone in patients with Heart Failure with Preserved Ejection Fraction HFPEF. This condition is common and serious, but currently lacks effective treatment. The trial is a phase 3 Registry-Randomized Clinical Trial RRCT involving patients from the Swedish Heart Failure Registry and the US. HFPEF is defined by heart failure symptoms, elevated NT-proBNP levels, and an ejection fraction of 40% or higher. Participants will be randomly assigned to receive either spironolactone added to their usual care or usual care alone. Spironolactone will be given as 25 mg tablets, starting at 25 mg per day with a possible increase to 50 mg daily if tolerated. If spironolactone is not tolerated, eplerenone may be prescribed instead. The control group will continue with their standard care without spironolactone. The study duration is planned for 9 years, with enrollment lasting 7 years. During the study, researchers will collect data on cardiovascular death and hospitalizations due to heart failure as the primary outcomes. Secondary outcomes include hospitalizations for various causes, adverse events, and treatment adherence. In Sweden, outcomes will be obtained by linking national registries, while in the US, sites and call centers will report outcomes. The trial aims to enroll approximately 2000 patients, with follow-up continuing for at least 5 years after study start to monitor these outcomes.

Researchers are investigating how different levels of physical activity, measured objectively, relate to health outcomes in patients who have had a type 1 myocardial infarction. The study aims to explore links between activities of varying intensity, sedentary time, and the risk of major cardiovascular events after a heart attack, as well as how changes in physical activity over time affect these outcomes. Participants in this observational study will be asked to wear an accelerometer device on their right hip during waking hours for seven consecutive days at two follow-up visits2 months and 1 year after hospital discharge. They will also keep a diary recording their wear time and working hours if applicable. About 4000 patients aged 18 to 79 diagnosed with myocardial infarction are expected to be included, and the study will analyze the dose-response relationship between accelerometer data and clinical outcomes. Throughout the study, participants will attend cardiac rehabilitation follow-up visits and provide accelerometer and diary data. Researchers will assess outcomes such as major adverse cardiovascular events, including heart failure, stroke, death, and coronary revascularization, at 1 and 3 years after the initial cardiac event. The study will monitor these outcomes while participants continue their usual care, with a total follow-up period extending to 3 years after the heart attack.

Researchers are evaluating the potential antitumor effects of tinzaparin, a commonly used anticoagulant, in women with advanced epithelial ovarian cancer EOC who are receiving neoadjuvant chemotherapy NACT. This pilot Phase II clinical trial aims primarily to assess how tinzaparin affects the levels of the tumor marker CA-125 during treatment. The study also explores how tinzaparin influences various immune and coagulation factors, and monitors compliance and side effects related to its use. Participants are randomly assigned to either receive daily subcutaneous injections of tinzaparin dose based on weight alongside standard chemotherapy with carboplatin and paclitaxel or to receive chemotherapy alone without tinzaparin. The treatment period spans 21 to 28 weeks, starting with chemotherapy and continuing through delayed primary debulking surgery DPDS and postoperative care. Blood samples for biomarker analysis are collected at multiple time points, including before each chemotherapy cycle, pre- and post-surgery, and after the last chemotherapy session. Patients in the tinzaparin group may choose to continue the anticoagulant following surgery and initial chemotherapy cycles. Throughout the study, women undergo clinical evaluations and imaging to guide surgery decisions. Researchers collect blood to measure markers such as hemoglobin, platelets, leucocytes, C-reactive protein, albumin, CA-125, and several coagulation and inflammation-related proteins. Compliance with tinzaparin injections and any treatment-related adverse events are closely monitored. The total participation time ranges from 22 to 29 weeks, covering chemotherapy, surgery, and follow-up periods.