Clinical Research Directory

Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial

Background: Carbetocin is an established single-dose uterotonic agent for postpartum hemorrhage prophylaxis at elective cesarean delivery. Despite its proven efficacy, many clinicians routinely add a supplemental oxytocin infusion following carbetocin administration without evidence-based justification. Concurrent oxytocin receptor stimulation may be redundant, counterproductive through receptor desensitization, or incrementally beneficial - a mechanistic uncertainty that remains unresolved in the published literature. Objectives: To determine whether carbetocin monotherapy (100 micrograms IV bolus plus placebo infusion) is non-inferior to carbetocin plus supplemental oxytocin infusion (10 IU over 4 hours) in preventing the need for additional uterotonic agents within 24 hours of elective cesarean delivery. Study Design: Prospective, randomized, double-blind, placebo-controlled, non-inferiority trial with an integrated pilot phase. Phase 1 (Pilot, n=60) establishes local feasibility and event rate. Phase 2 (Full trial, n=332) provides the definitive non-inferiority analysis. Participants: Women aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia at Qassim University Medical City, singleton pregnancy at or beyond 37 weeks, ASA physical status II, preoperative hemoglobin 9 g/dL or more. Interventions: Group C (Monotherapy): Carbetocin 100 micrograms IV bolus plus placebo saline infusion 500 mL over 4 hours. Group C+O (Combination): Carbetocin 100 micrograms IV bolus plus oxytocin 10 IU in 500 mL saline over 4 hours. Primary Outcome: Proportion of patients requiring at least one additional uterotonic agent within 24 hours of delivery. Secondary Outcomes: Quantitative intraoperative blood loss by gravimetric measurement; total 24-hour blood loss; actual blood loss by Gross formula; hemoglobin and hematocrit changes; uterine tone scores by verbal numerical rating scale (0-10) at 2, 5, and 10 minutes; incidence of postpartum hemorrhage; blood transfusion requirement; hemodynamic profiles; adverse effects. Sample Size: 332 patients (166 per group), non-inferiority margin 10 percentage points, one-sided alpha 0.025, 80% power, estimated baseline event rate 10%, with 15% dropout allowance.

Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)

The goal of this randomized, double-blind clinical trial is to learn if Oxytocin is most effective at achieving adequate uterine tone (important for preventing postpartum hemorrhage) when administered as a bolus or an infusion in patients at high-risk for postpartum hemorrhage in elective cesarean sections. The main questions that will be answered are: 1. Is Oxytocin bolus more effective than Oxytocin infusion at achieving adequate uterine tone at 2 minutes after the baby is born and every minute thereafter? 2. Does Oxytocin bolus cause less maternal side effects than Oxytocin infusion? 3. Does Oxytocin bolus result in less blood loss than Oxytocin infusion in high risk for postpartum hemorrhage patients undergoing elective cesarean sections? 3\. Are patients more satisfied with their cesarean section when they receive Oxytocin bolus or Oxytocin infusion? Researchers will compare the 2 methods of Oxytocin administration, bolus versus infusion, to see which method is more effective or if they are equally effective. Participants will: 1. Be randomized to receive either Oxytocin bolus or Oxytocin infusion during their cesarean section but after the baby is born. 2. Be asked a question about their experience 2 hours after the surgery. 3. Allow the research team to collect information about how they are doing from their hospital medical records.

Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony

This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean delivery in pregnancy patients at high risk for uterine atony.

Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage

Postpartum hemorrhage is the leading cause of maternal deaths in all over the world, especially in developing and underdeveloped countries. Medical and surgical methods exist for management of bleeding. There are two surgical techniques for removal of the placenta on cesarean delivery, which are called manual removal and controlled cord traction. In manual removal group, the duration of surgery time might be shorter theoretically. Nevertheless, there are studies showing that manual removal of the placenta may increase postpartum endometritis and postpartum hemorrhage. The optimal method for removal of the placenta during the cesarean delivery remains uncertain (1). It is a known fact that uterine massage after vaginal birth lowers the risk of postpartum hemorrhage (2) However, there is no study on how effective uterine massage is during cesarean delivery. In 2018, Saccone and colleagues wanted to publish a meta-analysis on the role of uterine massage in reducing postpartum bleeding during cesarean delivery, but when they examined the literature on the subject, they could not find a study which included only the group that gave birth by cesarean section and was free from bias. In the same publication, it was mentioned that it was necessary to investigate the effectiveness of uterine massage, which is a cost-free method that can reduce maternal morbidity in underdeveloped countries where maternal deaths due to postpartum bleeding are high, in cesarean section. (3)

Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone

During standard cesarean deliveries, there are two ways that obstetricians repair the incision on the uterus (hysterotomy after delivery of the baby. One method involves lifting the uterus out of its regular place in the abdomen to repair the incision (uterine exteriorization for repair). The second method involves leaving the uterus inside the abdomen to repair the uterus (in situ repair). Both of these methods are regularly used by obstetricians during cesarean deliveries, and it is not currently known if one has benefits over the other. Currently, surgeons use both methods, but lifting the uterus out of its place is slightly more common. In this study, participants will be randomly assigned to have one of these techniques performed during their surgery. Researchers will be investigating whether one technique or the other leads to better contraction of the uterus after delivery, less bleeding, less intra-operative nausea/vomiting, or a better patient experience than another.

Balloon Tamponade Versus Gauze Packing for Postpartum Hemorrhage

Postpartum hemorrhage due to uterine atony is a major cause of maternal morbidity and mortality. This randomized controlled trial aims to compare the efficacy of uterine balloon tamponade and uterine gauze packing in controlling bleeding in women with postpartum hemorrhage. A total of 216 participants will be randomly assigned to one of the two treatment groups. All patients will receive standard medical management including uterotonic agents prior to intervention. The primary outcome is cessation of uterine bleeding within 24 hours after the procedure. This study aims to identify a safe and effective method for managing postpartum hemorrhage in a resource-limited setting.