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Showing 1-20 of 109 trials
NCT03651076
This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.
NCT06729827
Single shot spinal anesthesia (SA) is the most commonly used technique for Caesarean section (CS) . SA is associated with maternal hypotension (Post Spinal Hypotension - PSH) often accompanied by nausea, vomiting, bradycardia and fetal acidosis. Preventive administration of vasopressors is widely used to counterbalance hypotension. Routine prophylactic infusion of phenylephrine and norepinephrine raises concerns for unnecessary treatment, reactive hypertension, baroreceptor-mediated bradycardia, and effects on fetal acidosis. Non-invasive continuous measurement of arterial pressure using a finger cuff is well established. Hypotension Prediction Index - HPI is an algorithm that could predict the onset of hypotension in working on invasive and non-invasive arterial waveform signal. The aim of this prospective randomized study is to compare the amount of PSH during elective caesarean section among two groups of patients receiving standard intermittent hemodynamic monitoring versus continuous ClearSight-HPI monitoring. The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of post-spinal hypotension, defined as mean arterial pressure (MAP) lower than 65 mmHg lasting more than one minute. The secondary aim was to study the impact of maternal PSH during CS on foetal outcome evaluated by comparing neonatal Apgar scores at 1 and 5 minutes after birth, and umbilical cord arterial and venous pH in the two groups.
NCT05380531
The purpose of this collaborative CTSA (Clinical and Translational Science Award) application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in breastfeeding mothers and their infants
NCT07192718
The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) and educational content on global postpartum recovery at 12 weeks post cesarean delivery.
NCT06242756
The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on hospitalization time (readiness to discharge), time to ambulation, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.
NCT07264933
The purpose of the study is to determine whether immediate postplacental copper T380A intrauterine device insertion increases uterine-niche incidence compared with postpartum progestin-only pills after primary cesarean section .
NCT07229222
The purpose of the study is to determine whether two-layered simple interrupted myometrial suturing is superior to double-layered continuous suturing for the prevention of uterine niche formation after primary cesarean section.
NCT06491368
The goal of this observational study is to determine the best time interval between consecutive cesarean sections and compare maternal and neonatal outcomes in women with a history of previous cesarean sections. The main questions it aims to answer are: * What is the optimal time interval between consecutive cesarean sections for minimizing maternal intraoperative complications, blood transfusions, and intra- and postoperative bleeding? * What are the differences in fetal and neonatal outcomes based on different time intervals between cesarean sections? Participants will be divided into five subgroups based on the time interval since their last cesarean section: 0-12 months, 12-24 months, 25-36 months, 37-48 months, and more than 48 months. Each participant will undergo an elective cesarean section and provide data on maternal and neonatal outcomes. Researchers will compare these subgroups to see if varying time intervals between consecutive cesarean sections affect maternal and neonatal outcomes.
NCT07369700
Cesarean sections (c-sections) are one of the most common surgical procedures done globally. However, there has been an increase in the number of c-section related complications. Women who deliver via c-section are nearly twice as likely to experience a complication (not including hemorrhage) as compared to women who deliver vaginally. One of the most commonly reported postoperative complications is surgical site infections (SSIs) - in this case, an infection of the c-section wound - with the highest rates of infection globally being in African regions (11.91%). In Rwanda, patients receive verbal instructions after surgery to return to the hospital should they experience an SSI or other complication. However, there is often patient delay in identification of complications and return to care, which increases rates of morbidity (illness) and mortality (death) from post c-section complications. The investigators think that if patient follow-up after operation is improved, this may reduce the impact of complications on patient health and well-being. This research is being done to evaluate the mHealth-CHW tool developed to support comprehensive home-based follow-up by community health workers (CHWs). Patients who have had c-section at Kirehe District Hospital will be recruited for this study, and will be randomly assigned to one of two groups: the intervention for home follow-up using the mHealth-CHW tool (referred to as Arm 1) or the standard of care (referred to as Arm 2). Individuals assigned to Arm 1 will be visited at home twice by a study CHW (sCHW) using the mHealth-CHW tool. They may be instructed to return to the health center for care based on the visit using the mHealth-CHW tool. Individuals in Arm 2 will follow the current standard of care and will be instructed to return to a health center every few days for follow-up until instructed otherwise. Regardless of the arm assignment, all participants will be instructed to return to Kirehe District Hospital 30 days after the date of their operation for a study clinic. At this study clinic they will undergo physical exam by a general practitioner (the healthcare provider who typically sees patients post c-section at the hospital level in Rwanda) and the study team will ask questions regarding financial expenditure for us to understand the rate of financial catastrophe experienced by both groups.
NCT07360756
The Optic Nerve Sheath Diameter (ONSD), measured non-invasively by bedside ultrasound, is a well-established surrogate for intracranial pressure (ICP), as the optic nerve sheath is continuous with the intracranial dura mater and its subarachnoid space is filled with cerebrospinal fluid (CSF). While ONSD is typically used to detect elevated ICP (with a cut-off often \> 5.0-5.7 mm for ICP \> 20 mmHg), studies investigating PDPH have paradoxically shown a reduction in ONSD post-spinal anesthesia, correlating with the state of intracranial hypotension. Previous research has demonstrated that a lower ONSD or a significant decrease in ONSD values 24 hours post-puncture is associated with PDPH development. A study determined that an ONSD at 24 hours of less than 0.40 cm was the best predictor for PDPH. Our study aims to specifically investigate the utility of the immediate change in ONSD to offer a bedside, real-time assessment of risk.
NCT06017076
It is not known which is better for intraoperative temperature protection, warming matress or preoperative oral functional drinks in elective cesarean section. We plan to conduct a non inferiority randomized trial to clarify this problem.
NCT04833556
Postpartum haemorrhage is the common cause of maternal death worldwide. The primary purpose of this study is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery.
NCT06219538
The goal of this study is to obtain user feedback while placing and observing the DAISY uterine drain with wall suction. This study defines the obstetrical surgeons as "users" and the patients in whom the drain is placed as "participants." Participants are pregnant women who are undergoing cesarean delivery (CD), who have not entered active labor, who have consented to drain placement and who have met all the inclusion/exclusion criteria. Users are staff or fellow obstetrical surgeons who will use the drain and provide the evaluation.
NCT07271056
The purpose of the study is to evaluated whether preoperative sublingual misoprostol can enhance the effectiveness and safety of niche resection in patients with symptomatic uterine niche.
NCT05953129
Jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) may be useful in estimating post spinal hypotension in cesarean section operations. Evaluation on the accuracy and effectiveness of these indices can contribute to the early diagnosis and management of hypotension. The main purpose of this study is to evaluate the effectiveness of shock indices in predicting the possibility of post spinal hypotension in cesarean section operations.
NCT07237776
Cesarean section is mainly performed using regional anesthesia, without preoperative sedatives, to facilitate the mother's conscious birth experience, reduce the need for neonatal resuscitation, and promote skin-to-skin contact immediately after birth between the mother and newborn. The VR can be designed to be an interacting and emotionally engaging environment that can stimulate emotionally related hormones. In stressful situations as CS, VR can generate a relaxation state that improves the surgery outcomes.
NCT05224726
When vessel wall injury occurs, platelets become activated, releasing more than 30 bioactive proteins, many of which have a fundamental role in hemostasis, inflammation and ultimate wound healing. Platelet-rich plasma (PRP), a modification of fibrin glue made from autologous blood, is being used to deliver growth factors in high concentration to sites requiring wound healing. PRP is obtained from a sample of patients' blood drawn at the time of treatment. As the rate of cesarean deliveries has been rising, long-term adverse sequelae due to uterine scar defects have been increasing. PRP might be a simple preventive treatment that potentially can reduce morbidity following cesarean deliveries.
NCT07130747
This study was done to compare the effect of myofascial release versus deep friction massage on abdominal recovery and scar after cesarean section.
NCT07049705
The study titled "Factors Influencing Bradycardia During Spinal Anaesthesia in Obstetric Patients Undergoing Caesarean Section"" aims to investigate the causes and patterns of bradycardia in pregnant women receiving spinal anesthesia during cesarean deliveries. Bradycardia, defined as a heart rate below 60 beats per minute, is a known complication of spinal anesthesia, often resulting from sympathetic blockade and unopposed parasympathetic activity. This condition may lead to hypotension, decreased cardiac output, and compromised fetal oxygenation.
NCT05312658
The goal of this clinical trial is to test if manual external aortic compression can prevent heavy blood loss in cesarean section. The main question\[s\] it aims to answer are: 1. Is external aortic compression effective? 2. Is external aortic compression safe? Participants will receive preventive manual external aortic compression or no external aortic compression (standard care) immediately after the baby is out at cesarean section. Blood loss will be measured, as well as kidney function, hemoglobin, and hematocrit before and after the operation. Experienced discomfort will be assessed the day after surgery and breastfeeding and signs of depression will be assessed using questionnaires after 2 months. Researchers will compare women with and without manual external aortic compression to see if there are differences in these outcomes.