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Cesarean Section clinical trials

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NCT ID: NCT06357546 Not yet recruiting - Cesarean Section Clinical Trials

Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section

C2S
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The hypothesis of this trial is that the absence of systematic bladder catheterization in patients performing spontaneous urination in the hour preceding the planned cesarean section under spinal anesthesia would not lead to more bladder heterocatheterization for postpartum urinary retention (RUPP) in the 24 hours post-cesarean section than systematic intraoperative bladder catheterization up to 2 hours post-surgery.

NCT ID: NCT06344169 Not yet recruiting - Cesarean Section Clinical Trials

Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section

Start date: April 15, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Intrathecal morphine (ITM) injection is considered as the standard pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention, constipation, mental status change, and respiratory depression. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard ITM and prevent the development of CPSP.

NCT ID: NCT06327165 Recruiting - Cesarean Section Clinical Trials

Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension

Start date: March 18, 2024
Phase:
Study type: Observational

Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 Hz very specifically reflects the parasympathetic nervous system. The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol.

NCT ID: NCT06316596 Not yet recruiting - Pregnancy Related Clinical Trials

Brain Oxygenation in Newborns Due to Neuroaksial Methods

oxygenation
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Epidural and spinal anesthesia techniques are frequently used all over the world in elective cesarean section operations. To evaluate the effects of epidural and spinal anesthesia techniques applied in cesarean section surgery on neonatal cerebral oxygenation using Near Infrared Spectroscopy (NIRS).

NCT ID: NCT06316024 Not yet recruiting - Cesarean Section Clinical Trials

Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function

Start date: March 2024
Phase: N/A
Study type: Interventional

The percentage of cesarean deliveries is on the rise, accounting for 30-40% of all deliveries in Taiwan. Following a cesarean delivery, a few doctors in Taiwan still adheres to the progressive eating regimen of "nothing per mouth" for 24 hours or until the patient passes flatus or hears bowel sounds. However, a meta-analysis has shown that early oral intake (6-8 hours) significantly reduces the time required for the restoration of gastrointestinal function and hospital stay compared to delayed oral intake. Furthermore, early oral intake has not shown to increase the likelihood of gastrointestinal complications. While several food types have been adopted for early oral intake, no study has investigated the effect of different food types on clinical outcomes regarding gastrointestinal function and hospital stay for cesarean delivery. Therefore, the objective of this study is to investigate the effect of different food types on clinical outcomes for cesarean delivery through a randomized controlled trial. The subjects of this study are pregnant women who come to Chiayi Christian Hospital to schedule cesarean deliveries. They are randomly assigned to one of four groups: nothing by mouth, water, juice/sports drink, or chewing gum. The relevant clinical outcomes, such as time to first bowel sound or readiness for discharge, are recorded. One-way analysis of variance or Chi-square test is used to compare the differences among the four groups. Our expected results could provide valuable information on the type of food that could be used to improve the recovery of mothers after cesarean delivery and increase the quality of breastfeeding.

NCT ID: NCT06304246 Not yet recruiting - Postoperative Pain Clinical Trials

The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section

Start date: March 1, 2024
Phase:
Study type: Observational

Adipokines are bioactive substances secreted from adipose tissue and have various functions on appetite, energy, lipid, carbohydrate metabolism, regulation of blood pressure, and inflammation. One of these is asprosin, discovered in 2016, which is secreted from white adipose tissue. It has been shown that the level of asprosin encoded by the Fibrillin 1 gene can vary in metabolic syndrome associated with obesity, diabetes, and insulin resistance . Some adipokines such as leptin, adiponectin, or resistin are found in increasing levels in the blood and placenta as pregnancy progresses. The detection of high concentrations of adipokines in cord blood has shown that they play an important role in fetal development and metabolism, can interfere with placental development, and affect pregnancy outcomes and fetal growth. Adipokines associated with appetite, energy, lipid, and carbohydrate metabolism have been shown to be effective in modulating pain in recent years. High levels of leptin have been shown to be associated with decreased preoperative pain threshold and increased postoperative analgesic consumption. Recent studies have indicated that asprosin also exhibits analgesic effects in neuropathic pain models and may have clinical benefits in alleviating chronic pain associated with diseases and injuries originating from peripheral structures. It is known that one of the most important factors affecting mothers' approach to anesthesia technique in Cesarean section is their fear of intraoperative and postoperative pain. Almost one in five patients experiences severe acute pain after Cesarean section. Pain can be perceived differently by patients, and even with the same anesthesia technique, some patients may experience more severe pain. Patients' perception of pain is influenced by many factors such as pain threshold, mood, hormonal balance, central sensitization, and genetic factors. We hypothesized that the increased preoperative serum asprosin levels might be associated with increased acute labor pain and that asprosin levels might lead to increased analgesic use in the postoperative period. Additionally, we assumed that patients could alter their preoperative pain threshold and report higher pain scores after surgery due to hyperalgesia caused by high asprosin levels. In this study, we aimed to investigate preoperative serum asprosin levels in patients undergoing Cesarean section with and without acute labor pain and to determine whether there is a relationship between preoperative asprosin levels and postoperative analgesic use.

NCT ID: NCT06303817 Completed - Pain Clinical Trials

Double Knots Versus Triple Knots Facia Closure Method; is There a Difference in Pain Sensation or Cosmetic Satisfaction?

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The study included women who were scheduled for an elective or had an emergency cesarean section. Age, body mass index (BMI), obstetric history, education status, smoking status and C-section indications of the patients were recorded. Patients with a previous suprapubic scar, medical conditions affecting wound healing (such as diabetes or chronic corticosteroid use), those needing a vertical incision (e.g., placenta previa), individuals with postoperative wound infection or under 18 years old were excluded. Data were collected in standardized data form by a research assistant. Pre- and post-surgery treatments and/or interventions were standardized. All patients received antimicrobial prophylaxis with cefazolin before the operation. The abdomen was entered via a transverse suprapubic skin incision and the surgical steps up to the point of facia closure were accomplished in a standard fashion. Technical differences such as blunt and sharp dissection, uterus exteriorization vs in situ, or parietal peritoneum closure were left to the surgeon's discretion. The procedures for facia closure are as follows; in Group I (Double knots group), the edge of the fascia was determined with a Kocher clamp. The fascia was closed starting from the opposite side with a synthetic absorbable multifilament suture in a continuous fashion up to the Kocher clamp and tied the knots with the same single suture (Figure 2; a-b). In Group II (Triple knots group), the edge of the fascia was fixed with the same suture material instead of the Kocher clamp, and the fascia was closed similarly, starting from the opposite corner via the second loop. Then the loops from the first suture were tied to the second suture (Figure 2; c-d). After the incision was irrigated with sterile saline solution, the subcutaneous space was closed if the thickness was 2 cm or more. Skin closure was accomplished with a subcuticular technique using a non-absorbable monofilament suture, which was removed on the 10th day postoperatively. A closed subcutaneous suction drain was not used in any of the patients. Postoperative pain at and around the incision line was measured on the 1st, and 10th days postoperatively on the NRS (Numeric Rating Scale), with "0" being "no pain" and "10" being "the worst pain imaginable." The 1st measurements were made face-to-face, and the 10th-day evaluation was made via telephone interviews by the same research assistant.

NCT ID: NCT06289335 Completed - Cesarean Section Clinical Trials

Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section

Start date: August 5, 2020
Phase: Phase 2
Study type: Interventional

Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia.

NCT ID: NCT06282952 Not yet recruiting - Clinical trials for Overweight and Obesity

NEwborn Infant of a Mother With Obesity - Fecal Microbiome Transplantation, RCT

NEMO-FMT
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section to obese mothers and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are: - Could fecal transplant be used improve gut microbiota and prevent overweight or obesity. - Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.

NCT ID: NCT06262243 Recruiting - Cesarean Section Clinical Trials

The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success.