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Cesarean Section clinical trials

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NCT ID: NCT02096003 Completed - Pain Clinical Trials

Intrathecal Hydromorphone for Pain Control After Cesarean Section

Start date: May 2014
Phase: Phase 2
Study type: Interventional

The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery. Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting. Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section. In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.

NCT ID: NCT02074852 Completed - Cesarean Section Clinical Trials

Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section

Start date: November 2012
Phase: N/A
Study type: Observational

The objective this trial is to compare immediate and 12 hours postoperative removal of urinary catheter after elective cesarean section; and whether early removal is associated with lower risk of urinary infection compared with delayed catheter removal.

NCT ID: NCT02046382 Completed - Pain, Postoperative Clinical Trials

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief

Start date: January 2014
Phase: Phase 4
Study type: Interventional

This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen among cesarean section patients. The study hopes to find out if patients who receive scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain scores and use less narcotic pain medication than patients who do not receive IV acetaminophen.

NCT ID: NCT02009722 Completed - Cesarean Section Clinical Trials

Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose

Start date: January 2014
Phase: Phase 4
Study type: Interventional

Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery. In this study, the investigators are going to determine the doses of each of those medicines that provides optimal pain control to women undergoing cesarean delivery while limiting side effects related to those medicines. The investigators hypothesize that the doses of hydromorphone and morphine that provide optimal pain control without significant side effects will be 100 micrograms and 150 micrograms, respectively. The investigators further hypothesize that at each respective optimal dose, side effects will be less in the hydromorphone group.

NCT ID: NCT01975805 Completed - Pregnancy Clinical Trials

Chlorhexidine Gluconate Versus Povidone Iodine at Cesarean Delivery: a Randomized Controlled Trial

Start date: January 2010
Phase: N/A
Study type: Interventional

Currently there are no published studies comparing the efficacy of Chloraprep and povidone-iodine in decreasing postoperative- wound infection in cesarean sections. However, there have been studies involving other types of surgery that have compared the efficacy of different types of preoperative cleansing agents in preventing postoperative wound infection. These studies have shown that controversy exists over which antiseptic skin preparation is the most effective for preventing postoperative surgical wound infections. The standard of care at Los Angeles County Hospital for preoperative skin antiseptic in cesarean sections is povidone- iodine 10% (betadine), however many other hospitals have made the transition to using Chloraprep. In an attempt to improve on the current standard of care, we propose a quality improvement prospective randomized study to compare the difference in postoperative wound complications with the use of povidone- iodine and Chloraprep as a preoperative antiseptic in cesarean sections. We hypothesize that Chloraprep will be better than Betadine at reducing the incidence of positive bacterial cultures following cesarean sections.

NCT ID: NCT01941628 Completed - Cesarean Section Clinical Trials

Comparison of Surgical Conditions in Cesarean Section Under General Anesthesia With Deep Neuromuscular Blockade Versus Succinylcholine

Start date: August 16, 2014
Phase: Phase 4
Study type: Interventional

Cesarean delivery under general anesthesia is one of few only surgical procedures, where the most important factor of safety is the speed of the surgery, as a newborn adaptation strongly depends on a time between induction to the general anesthesia (and administration of anesthetics) and pennywort ligation. The shortest possible interval is essential for the amount of anesthetics crossing placenta into the fetal circulation. The primary objective: To compare surgical conditions for fetus delivery in Cesarean section under general anesthesia with deep neuromuscular blockade versus standard procedure with succinylcholine. The primary safety objective: To compare influence of different levels of neuromuscular blockade and surgical conditions on newborn adaptation after the Cesarean delivery. The secondary objectives: To compare influence of deep versus no/shallow muscle blockade during the entire Cesarean section on surgical conditions for suture of the uterus and the abdominal wall with attention to blood loss, time of surgery and surgical complications. To describe pharmacodynamics and pharmacokinetics of deep neuromuscular blockade by rocuronium over the course of Cesarean section and its reversal by sugammadex at the end of procedure. Clinical hypotheses: The use of deep muscle blockade in Cesarean section under general anesthesia, including the period of fetus delivery, compare to the standard recommended practice with succinylcholine, will improve the surgical conditions and allow faster and easier delivery of the fetus with positive effect on its postnatal adaptation. Faster delivery will reduce an incision to delivery interval with decrease of time between anesthetics administration and delivery. This will reduce the amount of anesthetics crossing the placenta to the fetal circulation. Both, reduced amount of anesthetics and reduced incision to delivery interval itself will improve a newborn adaptation after Cesarean delivery. Deep neuromuscular blockade will also improve surgical conditions for the whole surgery, when no or shallow only neuromuscular blockade is routinely used. We assume that deep neuromuscular blockade during the entire surgery will create better surgical conditions for faster and easier uterus suture and the rest of surgery and thus reduce perioperative blood loss and incidence of surgical complications.

NCT ID: NCT01836315 Completed - Obesity Clinical Trials

Inflammation in Obese Parturients: Surgical Outcomes After Elective Caesarean Section

Start date: January 2013
Phase: N/A
Study type: Observational

Hypothesis: The investigators propose that obese parturients will have an increased inflammatory response and a decreased anti-inflammatory response to the surgical and anesthetic insult of caesarean section and that this will be associated with a higher rate of perioperative complications, as compared to non-obese parturients.2 Background: Obese patients exhibit higher levels of inflammatory markers than non-obese patients. Furthermore, obese patients have a higher incidence of perioperative complications, especially wound infections, and this is well documented in the caesarean section population. The pregnant population is unique as a result of the immunologic changes that occur at baseline, and an increase in pro-inflammatory markers is seen in serum and in placental tissue of obese subjects, and has been demonstrated to correlate with adverse fetal outcomes. Specific Objectives: To determine the baseline levels of three established markers of inflammation in term pregnant obese and non-obese patients (defined by a BMI > and < 35 kg/M2 respectively), and examine how they change in response to the stress of surgery/anesthesia. The investigators will correlate the inflammatory response with the incidence of postoperative wound infections. Methods: Patients will be recruited to the study prior to the planned caesarean section. Blood samples for inflammatory marker levels will be performed preoperatively, immediately postoperatively, and at 24 hours postoperatively. Samples will be analyzed for pentraxin-3 (a relatively novel inflammatory marker), C reactive protein (CRP) (a well-known and clinically relevant inflammatory marker), and interleukin-10 (IL-10) (an established anti-inflammatory marker). Plasma will be analyzed by ELISA to determine levels of each biomarker. Patient charts will be reviewed to determine which patients have experienced surgical complications in the 30 days postoperatively. Surgical complications will then be correlated with the measured levels of inflammatory markers. Assuming that the levels of inflammatory cytokines in obese patients will be 15% higher in obese parturients and assuming an alpha error level of 5% and a beta error level of 20%, the investigators would need to study 18 patients per group to prove our hypothesis that inflammatory cytokine levels are correlated with postoperative infections. The investigators plan to study 20 patients per group to account for a potential patient attrition rate of 10% during the study. Significance/Importance: The connection between obesity and dysregulation of the perioperative inflammatory response has not been well established nor has perioperative inflammation in the obese population been linked to the observed increased in perioperative morbidity. The investigators hope to demonstrate these connections and hopefully will be able to identify at risk patients earlier, and in a subsequent study intervene to reduce the risk of postoperative wound infections with pharmacokinetically targeted antimicrobial prophylaxis.

NCT ID: NCT01808807 Completed - Cesarean Section Clinical Trials

Factors Influencing Cesarean Section Rate: Does the Audit Still Work?

Start date: December 2012
Phase: N/A
Study type: Observational

To elucidate the audit's effect on caesarean section rate, and also define the factors influencing the caesarean section rate. From Jan 2007 , pregnant women who delivered in a medical center will be included retrospectively in this study. Our monthly cesarean section audit, focusing on discussing the indications of cesarean section, began from July 2008. Clinical data, indications of cesarean section, and perinatal outcomes were compared between the cases of before and after the audit. Multivariate logistic regression was performed to identify factors affecting cesarean section rate.

NCT ID: NCT01764048 Completed - Cesarean Section Clinical Trials

To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand

Start date: November 2012
Phase: N/A
Study type: Interventional

Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request). The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses). The protocols will be used for the first 48 hours following surgery.

NCT ID: NCT01741259 Completed - Cesarean Section Clinical Trials

A Comparison of Meperidine for Post-Cesarean Analgesia: Bolus Versus Infusion and Bolus

Start date: August 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if epidural meperidine administered by patient-controlled bolus button is equivalent to a low dose infusion plus patient-controlled bolus.