Varnamo

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.

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Researchers are evaluating whether remote video exercise-based cardiac rehabilitation (exCR) can increase participation in rehabilitation sessions after a myocardial infarction (heart attack), compared to traditional center-based exCR. The study is designed as a national multicenter registry-based cluster randomized crossover clinical trial, preceded by a feasibility and safety study conducted during the COVID-19 pandemic. Patients diagnosed with type 1 myocardial infarction and aged 18 to 79 years are included, with long-term follow-up planned at 1 and 3 years after the cardiac event. The study involves two phases: first, a feasibility study offering remote exCR at participating sites until the pandemic peak subsides, ending in August 2022; second, a randomized trial where cardiac rehabilitation centers are assigned to provide either remote exCR, usual center-based exCR, or a combination based on patient preference at intervention sites, while control sites offer only center-based exCR. The exercise program is standardized, requiring at least 24 supervised sessions over 3 to 4 months, each session including aerobic exercise and strength training at specified intensity levels. Success is defined as attending at least 75% of sessions within four months. Participants will be monitored through their attendance and adherence to the exercise sessions. Researchers will assess the average number of exCR sessions completed over 3 to 4 months. Additional evaluations include safety monitoring and long-term follow-up at 1 and 3 years to observe outcomes after the initial cardiac event. The study also considers patient access to internet for remote participation and evaluates exercise test results to ensure safety during rehabilitation.

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.