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 and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

Researchers are investigating the best timing for labor induction in low-risk pregnant women in China. While guidelines often suggest induction at 41 weeks, recent studies indicate that inducing labor at 39 weeks may reduce cesarean rates and improve outcomes. This study aims to compare induction at 39 weeks, induction at 41 weeks, and expectant management in the Chinese population, addressing a gap in population-specific evidence. Participants will be randomly assigned to either have labor induced between 39 weeks 0 days and 39 weeks 4 days or to expectant management until spontaneous labor or induction at 41 weeks. The study includes a pilot phase to test feasibility and will use advanced blood sample analyses to find biomarkers linked to long-term child health. Throughout the study, participants will have regular assessments including delivery outcomes, maternal and neonatal health measures, and follow-up evaluations at 6 weeks and 6 months postpartum. Researchers will track cesarean rates, neonatal complications, maternal hospital stays, and developmental scores to understand the effects of different delivery timings. The overall study period extends until mid-2028.

Postpartum hemorrhage PPH is the leading cause of death related to pregnancy, often resulting in severe complications such as blood transfusion, coagulation disorders, hysterectomy, or death. This trial evaluates whether administering calcium gluconate during the third stage of elective Cesarean delivery can reduce blood loss by lowering uterine atony and coagulopathy risks, addressing the ongoing high rates of PPH despite existing treatments. Participants will receive either 10 ml of 10% calcium gluconate diluted in saline or a placebo of normal saline intravenously after umbilical cord clamping, in addition to Carbetocin, a long-acting oxytocin analogue. The study uses a randomized, double-blind, parallel design with treatment allocation alternating by month. Blood samples and ECG monitoring are used to ensure safety and eligibility, excluding women with abnormal calcium levels or QT abnormalities. During the study, participants undergo blood gas analysis, coagulation profiles, and hemoglobin level monitoring before and after surgery, with follow-up blood tests the next day. Researchers will measure the change in hemoglobin levels 24 hours post-surgery as the primary outcome, along with secondary outcomes like blood loss during surgery, need for additional therapies, blood transfusions, hospitalization length, and adverse maternal events. The study aims to monitor safety and efficacy throughout hospitalization and track outcomes over an average of four days.

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.

This research study focuses on women undergoing cesarean section surgery and evaluates whether adding a Transversus Abdominis Plane TAP Block helps improve pain control after surgery. The TAP block is a nerve block where a long-acting local anesthetic is injected into the abdominal wall at the end of the surgery. Previous studies in other abdominal surgeries suggest this technique may reduce the need for narcotics, support more activity after surgery, and possibly shorten hospital stays. Participants are randomly assigned to one of two groups one group receives the surgeon-administered TAP block with 0.25% bupivacaine injected into the abdominal wall during surgery, while the other group does not receive the TAP block. The procedure is performed under direct visualization by the surgeon after uterine closure. Patients will not be told which group they are in, but no sham injections are given to the control group. During the study, participants will be monitored for pain levels 12 hours after surgery, time until they first request additional pain relief, opioid use up to 48 hours post-operation, and time until hospital discharge, usually within 1 to 3 days. The study also tracks safety and recovery outcomes. Participation involves surgery and follow-up assessments during the hospital stay, with the total study duration covering the post-operative period up to hospital discharge.

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.