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Cesarean Section Complications clinical trials

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NCT ID: NCT06010368 Not yet recruiting - Clinical trials for Cesarean Section Complications

Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

Start date: June 1, 2024
Phase: Phase 3
Study type: Interventional

Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent research has shown Egypt to be the third-largest country globally, with an estimated 52% cesarean sections (3). However, the cesarean section has many serious complications, including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter of blood following a vaginal birth and losing over one thousand milliliter after the cesarean section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in poor countries, and the estimated mortality number due to postpartum bleeding is one hundred thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to diminish maternal mortality and morbidity (7). The most successful technique for decreasing PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).

NCT ID: NCT05997498 Not yet recruiting - Clinical trials for Cesarean Section Complications

Mechanical Dilatation of the Cervix at Elective Caesarean Section on Post-operative Morbidity

Start date: August 30, 2023
Phase: N/A
Study type: Interventional

The study aims to evaluate the effects of cervical dilatation during cesarean section on postoperative maternal morbidity through different clinical parameters.

NCT ID: NCT05996926 Not yet recruiting - Clinical trials for Cesarean Section Complications

Diagnostic Accuracy of Saline Sonohystrography vs. 3D Transvaginal Ultrasound for Cesarean Scar Defect Assessment

Start date: August 30, 2023
Phase: N/A
Study type: Interventional

To compare accuracy of three dimensional transvaginal ultrasound versus the "gold standard" saline infused sonography for assessing the characteristics, frequency and appearance of caesarean scar defects in symptomatic patients with a history of cesarean section.

NCT ID: NCT05937217 Not yet recruiting - Clinical trials for Cesarean Section Complications

Quality of Life and Pain Pressure Threshold in Response to Scar Release Techniques for Chronic Transverse Abdominal Scar

Start date: July 5, 2023
Phase: N/A
Study type: Interventional

Postoperative scarring is one of the most common concerns among surgical patients. The incidence of abnormal scarring, i.e. keloid or hypertrophic scar formation after caesarean section (CS) is reported to be 41% .That can lead to functional limitations, pruritus, pain and cosmetic issues. so, the purpose of this study is to investigate quality of life and pain pressure threshold in response to myofascial induction and direct scar release techniques for lower transverse abdominal scar

NCT ID: NCT05791630 Not yet recruiting - Clinical trials for Cesarean Section Complications

The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)

NORWEL
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Appropriate and timely care during birth is critical to the survival and health of women and their babies. In 2020, the World Health Organization (WHO) presented the Labour Care Guide (LCG) as the new recommended tool for monitoring birth and assessing progression, replacing the WHO partograph. This evidence-based guide was designed to ensure improved quality and safety of care, and to avoid unnecessary interventions during birth. The LCG was developed to be used in all settings globally, but it has only been tested in health facilities in South America, Asia and Africa, while it has not been tested in high-income settings. Implementing a new guideline for monitoring birth is a comprehensive operation that will affect both the national economy, health systems, and individual patients; therefore, further research on the possible advantages is needed before national enrolment. Hence, the trial proposed in this application is crucial to form the required foundation of knowledge. The trial will be conducted in labour wards at ten hospitals, covering all health regions in Norway, and the established Norwegian Research Network for Clinical Studies in Obstetrics (NORBIRTH), with dedicated local principal investigators, will provide a robust research environment. This trial will test the effect of the LCG. Results from this trial will provide knowledge needed to determine a future implementation of the LCG in Norway.

NCT ID: NCT05488457 Not yet recruiting - Clinical trials for Cesarean Section Complications

Oxytocin Pharmacokinetics and Pharmacodynamics

Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus. After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship. The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.

NCT ID: NCT05396378 Not yet recruiting - Clinical trials for Gestational Diabetes

Early Recovery After Cesarean Delivery - Maternal Glucose Homeostasis Following Preoperative Glucose Dose

Start date: July 1, 2023
Phase:
Study type: Observational

Diabetic parturients planned for cesarean delivery will be recruited for the study. They will receive a fixed glucose dose to mimize the effects of fasting preoperatively and their blood glucose levels will be monitored.

NCT ID: NCT05391685 Not yet recruiting - Clinical trials for Cesarean Section Complications

EFFECT OF SCAR RELEASE TECHNIQUES ON CHRONIC SCAR PAIN AND MOBILITY POST CESAREAN SECTION

Start date: June 20, 2022
Phase: N/A
Study type: Interventional

Purpose of the study: The aim of this study is to determine the effect of scar release techniques on chronic scar pain and mobility post cesarean section. Hypothesis: - H0: There is no effect of scar release techniques on chronic scar pain and mobility post cesarean section. - HA: There is effect of scar release techniques on chronic scar pain and mobility post cesarean section.

NCT ID: NCT05233462 Not yet recruiting - Clinical trials for Cesarean Section Complications

Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia

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

General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section. Nevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally. To date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a "standardized dose" of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.

NCT ID: NCT05224726 Not yet recruiting - Clinical trials for Cesarean Section Complications

Platelet Rich Plasma for Uterine Scar

AA-PRP
Start date: December 2023
Phase: N/A
Study type: Interventional

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.