Clinical Research Directory

The Effect of Using Virtual Simulation on Students' Knowledge and Skill Levels Regarding Postpartum Hemorrhage Management

The purpose of this study is to find out whether virtual simulation helps nursing students learn how to manage postpartum hemorrhage (heavy bleeding after childbirth). Third-year nursing students taking the Obstetrics and Gynecology Nursing course were randomly assigned to one of three groups: virtual simulation, case study, or control. Students' knowledge was measured with a postpartum hemorrhage knowledge test, and their skills were assessed with a skill evaluation checklist during a hybrid simulation scenario. The results will show whether virtual simulation improves students' knowledge and skills compared with case study and standard education.

Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage

This study will investigate all women treated with vacuum-induced tamponade (VIT) for PPH at a tertiary center, namely at the University Hospital Zurich (USZ), over a nine-year period (2017-2025). By combining hospital data with follow-up patient questionnaires, it will provide new information on reproductive outcomes and contribute to the evaluation of the long-term safety profile of vacuum-induced tamponade.

Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth

During a waterbirth, blood lost in the pool between the birth of the baby and the mother's exit from the water cannot be collected or measured. At the participating centers, blood loss is measured with a graduated collector bag that is positioned only after the woman leaves the pool, for the delivery of the placenta. The blood loss recorded after a waterbirth may therefore be lower than the true loss. The goal of this observational study, conducted in two Italian hospitals, is to learn whether measured blood loss underestimates true blood loss more after waterbirth than after birth on land. The main question it aims to answer is: Is the difference between blood loss calculated from the drop in hemoglobin and blood loss measured in the collector bag larger in women who give birth in water than in women who give birth on land without water immersion? Researchers will compare three groups of low-risk women with a singleton pregnancy at term: women who give birth in water, women who use water immersion during labor but give birth out of water, and women who do not use water immersion. No intervention is assigned by the study: each woman is classified according to what actually happened during her labor and birth. Data are taken from the clinical record and include hemoglobin at admission in labor and after birth, measured blood loss, and the timing of events in the pool and during the third stage of labor.

Tranexamic Acid for Reducing Blood Loss in High-Risk Cesarean Delivery

This randomized study evaluated whether prophylactic tranexamic acid (TXA) reduces perioperative blood loss in women at increased risk of postpartum hemorrhage undergoing elective cesarean delivery. Women aged 18-45 years with at least one risk factor for postpartum hemorrhage were included. The anesthesia technique, spinal or general anesthesia, was selected before randomization based on clinical considerations and patient preference. Within each anesthesia group, participants were randomized to receive either 1 g intravenous TXA after umbilical cord clamping or no TXA. The main outcome was estimated blood loss calculated from perioperative hematocrit values. Other outcomes included postpartum hemorrhage, blood transfusion, changes in hemoglobin and hematocrit, need for additional uterotonic medications, adverse events, and thromboembolic events during follow-up.

Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics

The ClotPro analyzer is a new generation viscoelastic analyzer for the in vitro assessment of blood coagulation. This study aims to assess the agreement of ClotPro 6.0, ROTEM delta, and TEG 6s in three distinct cohorts: i) patients with liver disease undergoing liver surgery, ii) pregnant women undergoing elective cesarean section, and iii) patients undergoing elective intracranial neurosurgery. Additionally, following the introduction of Apiro Diagnostics test kits as a potentially equivalent alternative to ClotPro, agreement between MultiClot and ClotPro was assessed in a subset of patients. Further coagulation tests will be performed (standard laboratory coagulation tests, thrombin and plasmin generation tests) in an exploratory fashion to compare them with viscoelastic test results. The obtained test results will not result in any diagnostic or therapeutic consequences for patients included in this study.

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.

Effect of Simulation-Based Postpartum Hemorrhage Training on Team Performance in Senior Anesthesiology Teams

This prospective interventional study aims to evaluate the effect of simulation-based postpartum hemorrhage (PPH) training on team performance and crisis resource management skills among senior anesthesiology residents. Participants will undergo a structured high-fidelity simulation training program focused on postpartum hemorrhage management. Performance will be assessed before and after the intervention using validated assessment tools, including crisis resource management scoring systems. The study seeks to determine whether simulation-based training improves clinical decision-making, team communication, and overall performance in obstetric emergencies.

Hybrid Simulation in Postpartum Hemorrhage Training for Nursing Students

Abstract Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity worldwide, requiring nursing students to acquire both theoretical knowledge and clinical competence for safe and effective management. Hybrid simulation, integrating standardized patients with high-fidelity simulators, is an innovative educational approach that simultaneously enhances communication and psychomotor skills. This prospective randomized controlled study aims to evaluate the effects of a hybrid simulation-based postpartum hemorrhage management training on nursing students' learning satisfaction, self-confidence, and clinical readiness. The study was conducted with third-year nursing students at Eskisehir Osmangazi University Faculty of Health Sciences, Department of Nursing. Participants were randomly assigned to either an intervention group receiving hybrid simulation-based training using standardized patients and a birthing simulator, or a control group receiving routine education. Data were collected before and after the intervention using a Personal Information Form, the Student Satisfaction and Self-Confidence in Learning Scale, and the Nursing Clinical Readiness Scale to evaluate outcomes between the groups.

Efficacy of Balloon Tamponade in Post-partum Hemorrhage Within 24 Hours After Delivery

Postpartum hemorrhage (PPH) is a major cause of maternal death, especially in developing countries like Pakistan where it accounts for up to 34% of maternal deaths. When bleeding after delivery does not stop with medicines like oxytocin and uterine massage, a low-cost method called balloon tamponade can be life-saving. This study titled "Efficacy of Balloon Tamponade in Post-partum Hemorrhage within 24 Hours After Delivery" will be conducted by Dr. Maryam Aslam (PGR Gynecology and Obstetrics) under supervision of Prof. Dr. Raheela Farhat at Aziz Fatima Hospital, Faisalabad. The objective is to determine the efficacy of intrauterine balloon tamponade (condom catheter balloon) in controlling primary PPH. Efficacy is defined as successful control of bleeding within six hours of balloon insertion without need for additional surgery, confirmed by absence of active vaginal bleeding, a contracted uterine fundus, and stable maternal condition after removal of the balloon. The results will help promote a simple, effective procedure that can even be used by primary health care workers to reduce maternal mortality.

The Effectiveness of Serious Game-Based Training for Nursing Students in Postpartum Haemorrhage Management

This randomized controlled trial evaluated the incremental effect of adding a web-based serious game to standard theoretical instruction on third-year nursing students' postpartum hemorrhage management knowledge, task-specific self-efficacy, and self-regulated learning. Using census recruitment, all 159 eligible students were invited, and 120 students consented and were randomly allocated in a 1:1 ratio to the intervention or control group (60 participants per group) using randomly permuted blocks of four. Both groups received the same three 40-minute theoretical sessions. The intervention group additionally completed an individual, self-paced, 30-50-minute browser-based serious game featuring a single branching postpartum hemorrhage scenario, clinical decision-making, and immediate physiological feedback. The control group received no additional educational activity before the immediate posttest assessment. Outcomes were assessed at baseline before randomization and immediately after the intervention or control condition. Outcome data were analyzed by an independent analyst blinded to group coding.Data will be collected using the PPK Management Knowledge and Skills Assessment Form and the PPK Management Self-Confidence Scale.

Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage

The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal postpartum uterine bleeding or hemorrhage.

Effect of Oxytocin Bolus Versus Slow Infusion on Haemodynamic Stability During Caesarean Section Under Spinal Anaesthesia

This study compares two standard ways of giving oxytocin (a medicine that helps the uterus contract) after the baby is born during a planned caesarean section performed under spinal anaesthesia. One group of women will receive oxytocin as a quick injection into the vein. The other group will receive the same dose of oxytocin as a slow infusion over 15 minutes. The researchers want to find out which method causes less drop in blood pressure and other heart-related changes, while still providing good contraction of the uterus and preventing excessive bleeding.

Postpartum Video Education in High Risk Populations

This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs.

Pharmacokinetics of Oral Calcium Carbonate in Parturients

This study investigates the time course of change in calcium in the blood after a pregnant subject takes an oral dose of calcium carbonate (commonly marketed as "Tums"). Midway through the trial, with IRB permission, the oral calcium formulation was switched to calcium citrate to test whether this, better-absorbed formulation might prove more effective in increasing serum calcium. This information is important for trials investigating whether oral calcium can reduce postpartum hemorrhage, bleeding after delivery.

HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding

This observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works and how safe it is during routine medical care.

Comparison of the Efficacy of Misoprostol and Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery

Postpartum hemorrhage (PPH) is an obstetric emergency, with an estimated incidence ranging from 2.8% to 7.9%. Recent studies indicate an increasing trend in the frequency of PPH.Although it is more commonly seen in developing countries, it remains a significant cause of maternal morbidity and mortality worldwide. Therefore, early diagnosis and prompt, accurate intervention are critically important. Despite the rising incidence of PPH, maternal mortality rates have declined. This improvement is largely attributed to better identification of risk factors, timely diagnosis, and effective intervention. To prevent PPH globally, active management of the third stage of labor has been widely implemented. This approach includes the use of pharmacologic agents, uterine massage, and controlled traction for placental delivery.Among pharmacological agents, the most commonly used include oxytocin, ergot alkaloids (e.g., ergometrine), tranexamic acid, prostaglandin E1 (misoprostol), prostaglandin F2α, and oxytocin analogues (e.g., carbetocin).Oxytocin is the most widely used agent for PPH prophylaxis. The aim of this study is to compare the efficacy of tranexamic acid and misoprostol in the prophylaxis of postpartum hemorrhage.

Prevalence of Psychological Disorders After Immediate Postpartum Hemorrhage

The objective of this cross-sectional study is to assess the prevalence of depression at 2 months, 6 months, and 1 year postpartum in women who had an immediate postpartum hemorrhage (immediate PPH defined as blood loss ≥ 500 mL within 24 hours of delivery). The potential serious consequences of PPH may lead to a greater number of psychological disorders in these women than in women without PPH.

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.

Administration Of Calcium Gluconate for The Reduction of Blood Loss During Vaginal Delivery

Postpartum hemorrhage is one of the leading causes of maternal morbidity following childbirth. Even when excessive bleeding is not clinically recognized, some women experience a significant decrease in hemoglobin levels after delivery, which may result in anemia, fatigue, delayed recovery, and the need for additional medical treatment. Calcium plays an important role in uterine muscle contraction and blood clotting. Previous studies have suggested that calcium administration may help reduce blood loss after childbirth. However, there is limited evidence regarding its effectiveness during vaginal delivery. The purpose of this study is to evaluate whether administration of intravenous calcium gluconate immediately after umbilical cord clamping can reduce postpartum blood loss following vaginal delivery. Participants will be randomly assigned to receive either calcium gluconate or a placebo solution immediately after umbilical cord clamping during vaginal delivery. Neither the participants nor their healthcare providers will know which treatment was administered. Blood tests routinely obtained during hospitalization after delivery will be used to assess changes in hemoglobin levels and other outcomes related to postpartum bleeding. The results of this study may help determine whether calcium gluconate is a safe and effective intervention for reducing postpartum blood loss after vaginal delivery.

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)

Timing of Thromboprophylaxis After Postpartum Hemorrhage

Postpartum hemorrhage is a leading cause of maternal morbidity and mortality worldwide. Women who experience severe postpartum hemorrhage are at increased risk of both recurrent bleeding and venous thromboembolism. The optimal timing for starting pharmacological thromboprophylaxis after postpartum hemorrhage remains uncertain. This retrospective observational cohort study was conducted at the Center of Maternity and Neonatology of Tunis, Tunisia. The study included women who experienced postpartum hemorrhage between 2018 and 2024 and received pharmacological thromboprophylaxis during the postpartum period. The objective was to evaluate the association between the timing of thromboprophylaxis initiation and the occurrence of thromboembolic and hemorrhagic complications. The findings are expected to contribute to the optimization of thromboprophylaxis timing after postpartum hemorrhage and to improve the balance between the prevention of venous thromboembolism and the risk of recurrent bleeding.

Effect of Simulation-Based Education on Knowledge, Skills, and Self-Efficacy in Postpartum Hemorrhage Management

Postpartum hemorrhage is an important obstetric emergency that requires early recognition and timely management. Midwifery students may have limited opportunities to practise postpartum hemorrhage management repeatedly in real clinical settings. Simulation-based education may help students practise assessment, decision-making, emergency interventions, communication, and documentation in a safe learning environment. This study evaluated the effect of simulation-based education on third-year midwifery students' knowledge, postpartum hemorrhage management skill performance, and self-efficacy. Participants were randomly assigned to either an intervention group or a control group. Both groups received traditional theoretical education on postpartum hemorrhage management. The intervention group additionally received simulation-based postpartum hemorrhage management education using a high-fidelity birthing simulator. Knowledge and self-efficacy were assessed before the intervention, immediately after the intervention, and four weeks later. Skill performance was assessed immediately after the intervention and again four weeks later using a structured skills checklist. The study aimed to determine whether simulation-based education improved students' learning outcomes compared with traditional theoretical education alone.

IV Ketorolac on Platelet Function Post-Cesarean Delivery

Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption. The effect of NSAIDs on healthy volunteers results in inhibition of platelet aggregation and prolonged bleeding time. However, in the obstetric population, the presence and degree of platelet inhibition after NSAID exposure is less clear. The investigators plan to use Platelet Aggregometry and Thromboelastography (TEG) to evaluate the effect of ketorolac on platelets.

Concordance Between the Measurement of Whole Blood Fibrinogen by the qLabs®FIB Analyzer and Its Measurement by Conventional Method (Clauss Fibrinogen) in the Context of Severe Postpartum Haemorrhage

In France in 2021, 11.6% of deliveries were complicated by a postpartum haemorrhage (PPH), including 3.0% by severe PPH (the bleeding volume exceeds 1000 ml). Severe PPH is the 5th cause of maternal death (8.4% or 1.2 deaths per 100,000 live births). These deaths were considered preventable in 90% of cases. A plasma fibrinogen concentration below 2 g/L is considered as a critical threshold which constitutes a marker of severity of PPH and is significantly associated with the occurrence of severe PPH. Measuring the concentration of fibrinogen using a rapid test, simple to perform and interpret, available in the delivery room could optimize the management of severe PPH. The qLabs®FIB analyzer distributed by the Stago Biocare laboratory for the rapid determination of the fibrinogen concentration at the patient's bedside could meet this objective.