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Cesarean Section clinical trials

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NCT ID: NCT05051150 Terminated - Cesarean Section Clinical Trials

Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section

Start date: September 15, 2021
Phase: Phase 4
Study type: Interventional

Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Therefore, it is highly recommended to use vasopressors, preferably as continuous infusion, for prophylaxis rather than delaying their use until hypotension occurs. Phenylephrine (PE) is the recommended drug for prophylaxis against hypotension during cesarean delivery; however, the use of PE is commonly associated with decreased heart rate and probably cardiac output because PE is a pure alpha adrenoreceptor agonist . Introduction of NE in obstetric practice had shown favorable maternal and neonatal outcomes and was associated with higher heart rate and cardiac output compared to PE. However, there is still some mothers who develop bradycardia and diminished cardiac output with the use of NE. The most desired scenario during hemodynamic management of mothers during cesarean delivery would achieve the least possible incidences of maternal hypotension, bradycardia and reactive hypertension. Therefore, it is warranted to reach a vasopressor regimen with the most stable hemodynamic profile. In the last year, epinephrine was reported for the first time in obstetric practice with acceptable safety on the mother and the fetus. However, there is still lack of data about the most appropriate dose for infusion during cesarean delivery. In this study, we aim to compare three prophylactic infusion rates for epinephrine during cesarean delivery.

NCT ID: NCT04033562 Terminated - Pregnancy Related Clinical Trials

The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

Start date: January 15, 2020
Phase: Phase 4
Study type: Interventional

Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

NCT ID: NCT03772886 Terminated - Obesity Clinical Trials

Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball

Start date: September 9, 2019
Phase: N/A
Study type: Interventional

This study aims to determine if using the peanut ball during labor reduces the cesarean delivery rate when compared to normal intrapartum management (no peanut ball) in the obese patient population.

NCT ID: NCT03695172 Terminated - Pain, Postoperative Clinical Trials

Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section

Start date: September 12, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this prospective single center, randomized study is to determine if ultrasound guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section.

NCT ID: NCT03423147 Terminated - Cesarean Section Clinical Trials

Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor

PRACTICAL
Start date: October 5, 2018
Phase: Phase 2
Study type: Interventional

Surgical site infections (SSI) are the second most common cause of nosocomial infections accounting for 15% of all nosocomial infections among hospitalized patients and 38% of nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor. Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria, reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI. Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is limited. This study intends to evaluate the effectiveness of use of both chlorhexidine gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean section that have previously been laboring. Patients will be randomized to one of two groups: wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal scrub in addition to standard preoperative scrub as compared to standard preoperative scrub alone.

NCT ID: NCT03009110 Terminated - Cesarean Section Clinical Trials

Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial

Prevena-C
Start date: February 8, 2017
Phase: N/A
Study type: Interventional

The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device - to decrease surgical site infections (SSIs) in obese women.

NCT ID: NCT02787928 Terminated - Cesarean Section Clinical Trials

Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System

Start date: April 2016
Phase: Phase 1
Study type: Interventional

In the United States the incidence of cesarean deliveries have increased over the last several decades and is currently approximately 30% nationwide. The anesthesia and analgesia for elective c-sections vary between institutions. Parturients present a unique challenge for the anesthesiologist as the mother has to care not only for herself, but also for the newborn postpartum. While intrathecal opioids provide adequate pain relief, they do so at the cost of bothersome side effects for patients, such as pruritus and nausea/vomiting. Intrathecal hydromorphone has started to be explored as a new option for intrathecal analgesia. A study done by Beatty et al. showed in a retrospective review that 40 mcg of intrathecal dilaudid was safe and effective as compared to intrathecal morphine for analgesia after cesarean delivery. Additionally they showed no difference in side effect profiles of the two medications. Mhyre et al. investigated the use of 100 mcg of intrathecal dilaudid with hyperbaric bupivacaine in varying dosages for labor analgesia. The results were inconclusive, but the dosage of hydromorphone was reported to be without adverse effects. Virginia Commonwealth University Health Systems has successfully instituted the use of intrathecal morphine with superior analgesia but with undesired side effects, most notably pruritus. Recent drug shortages of duramorph have prompted investigators to seek alternative options for post cesarean section analgesia. The investigators are interested in determining the dose, efficacy, and side effect profile of intrathecal hydromorphone. Although our institution has never utilized intrathecal hydromorphone for our patient population, it has been studied at various other institutions where it has been found to be safe and efficacious with an acceptable side effect profile.

NCT ID: NCT02167438 Terminated - Cesarean Section Clinical Trials

Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer

Start date: October 2014
Phase: N/A
Study type: Interventional

This study is being conducted to evaluate an FDA approved device called the HEM-AVERT® Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the second stage of labor times.

NCT ID: NCT01687972 Terminated - Pregnancy Clinical Trials

INSORB Versus Subcuticular Sutures at Cesarean Section

Start date: September 2011
Phase: Phase 1
Study type: Interventional

The proposed study is a randomized controlled trial with two arms. All patients admitted to Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section, the patient will be randomized at time of cesarean section to receive skin closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this visit. The patient will then be contacted by telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting scar.

NCT ID: NCT01190163 Terminated - Cesarean Section Clinical Trials

Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction

SOFTNES
Start date: June 2010
Phase: Phase 4
Study type: Interventional

This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.