Vastervik

Researchers are evaluating whether using the World Health Organization's Labour Care Guide (LCG) instead of standard care for monitoring labor progress can improve outcomes for newborns and mothers. This study compares these two guidelines to see if the LCG can reduce adverse neonatal outcomes, such as perinatal mortality, neonatal complications, and the need for cesarean sections during labor. The research also looks at other perinatal interventions, complications, and economic factors, using a multicenter, stepped-wedge cluster randomized trial design conducted from 2023 to 2025 in Sweden. Participants will receive care based on either the WHO's LCG or standard labor monitoring guidelines. The LCG is a next-generation partograph designed to follow the latest intrapartum care recommendations. The study involves multiple delivery units where women in active labor receive monitoring according to the assigned guideline. Researchers will compare outcomes such as neonatal morbidity, cesarean section rates, use of oxytocin, postpartum hemorrhage, labor duration, and experiences of women, their partners, and healthcare providers. Throughout the study, participants will be monitored for neonatal complications including low Apgar scores, hypoxic ischemic encephalopathy, intracranial hemorrhage, seizures, meconium aspiration syndrome, and neonatal unit admissions. The study will also assess maternal outcomes and collect feedback via questionnaires and interviews about childbirth experiences and guideline compliance. The primary outcomes are adverse neonatal events and intrapartum cesarean rates, with follow-up from 12 weeks up to 18 months after birth to gather comprehensive data on health and safety.

Researchers are evaluating treatments for elderly patients aged 75 and older who have an undisplaced femoral neck fracture (uFNF), classified as Garden I-II. The study compares whether replacing the hip (arthroplasty) reduces the need for further surgeries compared to preserving the hip with internal fixation. The goal is to lower the combined risk of needing reoperation or death within 1 to 2 years after surgery. Participants are randomly assigned to one of two treatment groups using the Swedish Fracture Register. One group receives arthroplasty, which may be either a hemi or total hip replacement depending on hospital routine based on patient age and mobility. The other group undergoes internal fixation, where the fracture is repaired using 2-3 screws, pins, or a sliding hip screw device, again according to hospital routine. Both treatments are devices applied to stabilize or replace the hip after fracture. During the study, participants are monitored for outcomes including the rate of additional surgeries and mortality up to 2 years after their initial operation. The main measure combines these two outcomes into a single variable to evaluate overall treatment success. The entire process is registered and randomized within the Swedish Fracture Register system, ensuring consistent follow-up and data collection.

Heart failure with preserved ejection fraction (HFPEF) is a common and serious condition without effective treatment options. Researchers are evaluating whether adding spironolactone, a medication, to standard care can reduce the combined risk of cardiovascular death and hospitalizations for heart failure in patients with HFPEF. This study is a Phase 3 trial including patients from the Swedish Heart Failure Registry and the US, all having symptoms of heart failure, elevated heart-related blood markers, and an ejection fraction of 40% or higher. Participants are randomly assigned to one of two groups: one receiving spironolactone along with usual care, and the other receiving usual care alone without spironolactone. The study is designed as a registry-randomized clinical trial and will continue until 721 cardiovascular death or heart failure hospitalization events occur, with an enrollment period of 7 years and a total study duration of 9 years. Data collection in Sweden uses registry linkages, while data in the US comes from site reports and supplemented call center follow-up. During the study, researchers will monitor participants for hospitalizations due to heart failure or cardiovascular death as the primary outcome. Secondary outcomes include other hospitalizations, side effects, and how well patients follow their treatment plans. Outcomes are tracked through national registries and direct reporting, with the main data locked and analyzed five years after the study begins. Approximately 2000 patients aged 50 to 99 years will be included to achieve the event target needed for study conclusions.

Researchers are studying the relationship between different levels of physical activity, sedentary time, and health outcomes in patients who have had a myocardial infarction (heart attack). The main goal is to understand how activity measured by accelerometers relates to clinical outcomes and how changes in physical activity over time affect these outcomes after a heart attack. The study plans to include about 4000 patients over two years who have experienced a myocardial infarction. Participants will wear an accelerometer device attached to their right hip during waking hours for seven consecutive days at two follow-up visits: once at 2 months and again at 1 year after hospital discharge. They will also keep a paper diary to record device wear time and working hours, then return both by mail. This process is repeated at the 1-year follow-up. During the study, participants attend follow-up visits where their physical activity data are collected and analyzed. Researchers will explore how different intensities of activity relate to major adverse cardiovascular events one year after the heart attack. Safety and adherence are monitored by collecting activity diaries and accelerometer data. Participation spans from hospital discharge through at least one year after the event to track outcomes and physical activity changes over time.

Researchers are investigating the effects of tinzaparin, a commonly used anti-coagulant, on women with epithelial ovarian cancer (EOC) who are undergoing neoadjuvant chemotherapy (NACT). This pilot Phase II randomized controlled trial focuses on patients with advanced FIGO stage III-IV EOC, aiming to evaluate tinzaparin's potential antitumoral effects by measuring changes in the cancer biomarker CA-125. The study also explores how tinzaparin influences immune and coagulation factors and monitors patient adherence and any side effects from the treatment. Participants are randomly assigned to receive either daily subcutaneous injections of tinzaparin or no tinzaparin alongside their standard chemotherapy with carboplatin and paclitaxel every 21 days. Blood samples for various biomarkers are collected before treatment, before each chemotherapy cycle, before delayed primary debulking surgery (DPDS), and after surgery. Patients undergoing DPDS will receive tinzaparin for 28 days postoperatively and continue chemotherapy for an additional two to three cycles. Those initially on tinzaparin may choose to continue it during these cycles. Patients not undergoing surgery remain in the study for three chemotherapy cycles. The total study duration ranges from 22 to 29 weeks. During the trial, participants undergo clinical and imaging evaluations after three chemotherapy cycles to determine surgical eligibility. Researchers collect blood samples to analyze markers of cancer, inflammation, and coagulation, including CA-125 levels at week 14 as the primary outcome. Patient safety, treatment compliance, and adverse events are carefully monitored throughout the study period. This comprehensive approach allows assessment of tinzaparin's impact on cancer progression and patient health during and after chemotherapy.