Cesarean Section

Spinal anesthesia-induced hypotension is a common and significant complication affecting up to 50-80% of pregnant women undergoing elective cesarean section. This trial evaluates whether a brief 5-minute mindfulness-based breathing exercise given just before spinal anesthesia can influence blood pressure changes during surgery. The study compares this breathing technique to standard care in pregnant women aged 18 to 45 years scheduled for elective cesarean delivery. Participants will be randomly assigned to either perform the mindfulness-based breathing exercise or receive standard preoperative care. The breathing exercise involves slow diaphragmatic breathing at about six breaths per minute, guided by a trained anesthesiologist or nurse, with mindful repetition of the phrase "My body is relaxing as I exhale." Both groups receive spinal anesthesia with specific medications, and careful monitoring of heart rate and blood pressure is performed. During the study, participants will be closely observed for changes in systolic blood pressure and heart rate within 10 minutes after spinal anesthesia. Anxiety levels, incidence of early hypotension, and medication use to support blood pressure will also be measured. The trial includes standard monitoring such as ECG and oxygen saturation, with safety and response data collected throughout the procedure. Participants' involvement includes a short breathing exercise or equivalent wait time before anesthesia, with follow-up assessments during surgery.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

Researchers are studying the best timing for labor induction in low-risk pregnant women in China. This trial compares induction at 39 weeks, induction at 41 weeks, and expectant management to see which approach leads to fewer cesarean deliveries and better outcomes for mothers and babies. The study will also use advanced techniques to analyze cord blood for early markers linked to child health. It starts with a pilot phase to test feasibility and plan for a larger study. Participants will be randomly assigned to one of two groups: induction of labor between 39 weeks 0 days and 39 weeks 4 days, or expectant management until spontaneous labor or induction at 41 weeks. The trial focuses on women assessed as low-risk for delivery before 41 weeks. The study aims to generate evidence specific to the Chinese population to support safer and more personalized care. During the study, women will be monitored for delivery outcomes, including cesarean rates and maternal and newborn health indicators. Researchers will collect data on various maternal and neonatal complications, hospital stays, and costs. Follow-up assessments will occur at hospital discharge and at 6 weeks and 6 months after birth, including developmental evaluations of the child. The main outcome measured is the rate of cesarean delivery on the day of birth.

Postpartum hemorrhage (PPH) is a leading cause of death related to pregnancy, potentially causing blood transfusion, clotting disorders, hysterectomy, or death. This research evaluates whether giving calcium gluconate during the third stage of elective cesarean delivery can reduce blood loss by lowering uterine atony and coagulopathy rates. Calcium is important for blood clotting and muscle contraction, and low calcium levels are linked to severe bleeding and poor uterine muscle function. Participants will receive either 10 ml of 10% calcium gluconate diluted in saline or a saline placebo intravenously after umbilical cord clamping, both alongside a standard drug called Carbetocin. The study uses a double-blind, randomized design where the calcium or placebo is given according to a schedule known only to the primary researcher. Blood and heart tests will be done before and after surgery to monitor calcium levels, blood clotting, and heart function, while patients are continuously monitored for safety. Women in the study will have blood samples taken for calcium and coagulation analysis before and after surgery, along with routine blood counts the day after. Researchers will measure the change in hemoglobin levels 24 hours after surgery as the main outcome. Other evaluations include blood loss during surgery, need for additional treatments or blood products, length of hospital stay, surgery duration, and any adverse maternal outcomes. The total hospital stay is about four days, during which close monitoring will occur to assess safety and effectiveness.

This clinical trial focuses on pregnant women with a breech presentation who are scheduled for an external cephalic version (ECV), a procedure to turn the baby to a head-down position before birth. The study aims to determine if watching an informative video before the planned ECV can reduce maternal anxiety and improve the chances of a successful version. The trial is randomized and sponsored by Meir Medical Center. Participants are divided into two groups: one group watches an informative video that explains the ECV process in detail, while the other group does not watch any video before the procedure. Sonographic data such as amniotic fluid index, fetal weight estimates, placenta location, and fetal position angles are collected in the Emergency Room. Anxiety levels are measured using the State-Trait Anxiety Inventory both before and an hour after the ECV, regardless of success. Women in the study will undergo the ECV procedure with clinical monitoring and data collection before and after the intervention. Researchers will assess the primary outcome of higher success rates of the ECV over four years and a secondary outcome measuring the impact of the video on maternal anxiety levels. Participation involves scheduled assessments and monitoring during the procedure, with follow-up for anxiety evaluation and success rates.

Researchers are evaluating whether adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients undergoing a cesarean section. This randomized clinical trial aims to see if this nerve block injection, given into the abdominal wall at the end of surgery, can reduce the need for narcotic pain medications. Previous studies involving other abdominal surgeries suggest that TAP blocks may help patients be more active after surgery and possibly reduce hospital stay time. The study compares two groups: one receiving the surgeon-administered TAP block using 0.25% bupivacaine at a dose of 0.25 mL/kg on each side of the abdomen after uterine closure, and the other receiving no TAP block. The procedure involves precise injection into the transverse abdominis plane under direct visualization during surgery. Patients will not know whether they received the injection, and no sham procedure will be performed. Participants will be monitored for their pain levels 12 hours after surgery as the primary outcome. Secondary outcomes include the time until first request for additional pain relief within 48 hours, total opioid use up to 48 hours post-operation, and the time from surgery until hospital discharge, usually between 1 and 3 days. The trial involves random assignment and double masking to ensure unbiased results, with study-related care provided throughout the hospital stay and follow-up.

Persistent postoperative pain is a significant issue worldwide, particularly following cesarean section surgery. This observational study aims to understand how often and in what ways chronic pain occurs after cesarean section at 3, 6, and 12 months post-surgery. It also explores how factors around the time of surgery relate to chronic pain and examines the connection between long-lasting pain and postpartum depression in mothers. The study observes women who have undergone cesarean section with a specific surgical approach (transverse incision in the lower uterus). Participants will be followed prospectively without any intervention, focusing on data collection related to their pain experience and other postoperative conditions. This research will use data modeling and regression analysis to identify risk factors for chronic pain and associated complications. Participants will be monitored through follow-up visits up to 12 months after surgery, during which their pain levels and any signs of depression will be assessed. Researchers will collect information on pain incidence and characteristics, adverse effects related to pain management, and other relevant outcomes. The total participation period spans from surgery through one year of postoperative observation, allowing detailed tracking of symptoms and their impact on quality of life.

Women undergoing gynecologic oncology surgery often experience significant preoperative anxiety due to concerns about cancer diagnosis, survival, loss of reproductive organs, body image, and sexual health. This anxiety can negatively affect physiological parameters such as heart rate, blood pressure, respiratory rate, and oxygen saturation, increasing surgical risks and discomfort. Researchers are evaluating whether a virtual reality (VR) intervention can reduce this anxiety and improve patient satisfaction before surgery in a randomized controlled trial. Participants will be randomly assigned to either an intervention group receiving a 20-minute virtual reality relaxation session using visual and auditory stimuli delivered via a VR headset, or a control group receiving standard preoperative care. Anxiety levels and physiological parameters will be measured immediately before and after the intervention or standard care session. Patient satisfaction with the preoperative experience will be assessed once immediately after the intervention and before surgery. During the study, women aged 18 years or older with confirmed gynecological cancer scheduled for their first laparotomy surgery will participate. Assessments include anxiety scoring, blood pressure, heart rate, respiratory rate, and oxygen saturation before and after the intervention. Patient satisfaction will be evaluated before surgery. Safety and adherence will be monitored, including observation for any medical complications or withdrawal. The study aims to provide evidence for VR as a nurse-led, non-invasive method to enhance preoperative care in gynecologic oncology surgery.

Researchers are studying whether adding azithromycin to the usual antibiotics given before a scheduled or prelabor cesarean delivery can reduce infections after surgery. This phase III trial involves 8,000 individuals and compares azithromycin with a placebo while all participants receive standard antibiotics. The main goal is to see if azithromycin lowers the risk of infections such as wound infections, sepsis, pneumonia, and breast infections up to six weeks after delivery. Participants are randomly assigned to receive either 500mg of intravenous azithromycin or a placebo (normal saline) about one hour before the cesarean incision. Both groups also get the standard antibiotic treatment before surgery, excluding azithromycin. Blood samples from the mother and baby may be collected in some cases. Researchers will track health outcomes related to infections and other complications during delivery and hospital stay. Participants will have one follow-up visit between 4 and 8 weeks after giving birth to assess both maternal and newborn health. During the study, medical records will be reviewed to monitor outcomes. The trial will measure infection rates, wound complications, hospital stay length, neonatal intensive care admissions, use of healthcare resources, and presence of antibiotic-resistant infections. The total study period for each participant lasts up to six weeks postpartum.

This research aims to understand the relationship between changes in carotid artery blood flow and low blood pressure following spinal anesthesia in pregnant women aged 20 to 40 undergoing cesarean delivery. The study focuses on how carotid blood flow and corrected flow time measurements change before and after spinal anesthesia and their connection to post-spinal hypotension. Participants are women classified as ASA 1-2 with uncomplicated pregnancies at term. Participants will receive spinal anesthesia with a standardized dose of 10 mg heavy bupivacaine and 10 mcg fentanyl as part of their cesarean delivery. Doppler ultrasound will be used to measure the diameter and flow velocity of the left carotid artery at three different points before anesthesia and repeated three minutes after returning to the supine position post-anesthesia. Blood pressure and fluid administration will be monitored from the start of anesthesia until delivery to assess hypotension occurrence. During the study, each participant will undergo two carotid ultrasound exams performed by the same investigator. Hemodynamic data, including blood pressure changes and fluid resuscitation, will be recorded throughout the procedure. The main outcome measured is post-spinal hypotension between anesthesia and delivery, with secondary outcomes including the amount of fluid given. The study participation involves minimal additional procedures beyond standard care and ultrasound measurements.