Clinical Research Directory

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 PPH 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.

Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study

This study is designed to determine the minimal effective oxytocin maintenance infusion required in labouring women undergoing cesarean delivery to achieve the best effect. Oxytocin is a drug that is routinely used to help the uterus to contract and keep it contracted after delivery. Consequently, it will help to reduce blood loss after delivery. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. The next patient's infusion dose of oxytocin, will either increase or decrease, depending on how the previous patient responds in terms of uterine tone. If the response is satisfactory with the infusion dose used, the next patient will either receive the same infusion dose or it will be decreased depending on a probability of 1:9. If the response is not satisfactory, then the infusion dose will increase for the next patient. The dose for each patient will be determined based on the results of the uterine contraction of the previous patient. The investigators hypothesize that the ED90 of the oxytocin infusion rate to maintain adequate uterine tone in labouring women with induced or augmented labour undergoing cesarean delivery, following an initial effective bolus dose, would be lower than 0.74 IU/min (44 IU/h), which was found as the ED90 in a previous study, without an initial bolus dose prior to the infusion.

Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study

The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes. Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH. It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory.

Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium

This study will investigate the effects of drugs called "uterotonics" that help with the contraction of the uterus after a baby is born. This uterine contraction is very important to stop the bleeding after delivery. An uncontracted uterine state is called "uterine atony", which can lead to an excessive amount of post-delivery bleeding. Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding. In some cases, carbetocin is not enough to contract the uterus, and ongoing bleeding continues. When that happens, there are other uterotonic medications that can be used. In this study, we aim to find which uterotonic drug, amongst those available (oxytocin, carbetocin, ergometrine or carboprost), is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered. This study will be done by using a very small sample of uterine tissue, taken from the incision site, following delivery by cesarean section. The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs. The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further.

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.

Umbilical Cord Drainage to Prevent Postpartum Hemorrhage

This study aims to analyze whether there is a significant difference in the occurrence of postpartum hemorrhage between women who underwent umbilical cord drainage and those who did not. Variables such as estimated blood loss volume, drop in hemoglobin levels, and the need for additional maneuvers or treatments to control hemorrhage will be examined. The research will be conducted under a parallel-group clinical trial design at the Hospital Escuela Universitario. Post-birth umbilical cord drainage may contribute to a lower frequency of postpartum hemorrhage compared to not performing it.

Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage

The goal of this clinical trial is to learn if the drug carbetocin works better than standard care to prevent heavy bleeding after childbirth in people carrying twin pregnancies. Heavy bleeding after delivery, also called postpartum hemorrhage, is more common after twin births and can lead to anemia, blood transfusions, and other serious health problems. In this study, bleeding will be evaluated by measuring how much blood hemoglobin levels drop from before delivery to the day after delivery. The main questions this study aims to answer are: * Does giving carbetocin after delivery lower blood loss compared with standard oxytocin treatment? * Is carbetocin safe and practical to use in twin deliveries? Researchers will compare carbetocin to standard oxytocin treatment to see which approach better prevents bleeding after twin vaginal or cesarean delivery. Participants will: * Be randomly assigned to receive either carbetocin or standard oxytocin after the second twin is delivered * Have blood tests before delivery and on the day after delivery * Be followed during their hospital stay and for up to six weeks after delivery for safety outcomes

Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention

Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, particularly among women with known risk factors. Uterotonic agents are routinely administered after vaginal delivery to prevent excessive bleeding. Carbetocin, a long-acting oxytocin analogue, and misoprostol are both used for this purpose, but comparative data in high-risk vaginal deliveries remain limited. This prospective randomized study aims to compare the effectiveness and safety of intravenous carbetocin versus rectal misoprostol for the prevention of postpartum hemorrhage in women with risk factors undergoing vaginal delivery at Galilee Medical Center. The primary outcome is the incidence of postpartum hemorrhage. Secondary outcomes include the need for additional uterotonic agents or surgical interventions, changes in hemoglobin levels, blood transfusion requirements, and maternal adverse effects.

Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage

Postpartum hemorrhage (PPH) is the global leading cause of maternal death, with 20-30% of maternal deaths in Thailand linked to hemorrhage. The WOMAN Trial (2017) provided strong evidence that administering tranexamic acid (TXA)within three hours of bleeding onset lowered PPH-related mortality by 31%. Consequently, the World Health Organization (WHO) updated its guidelines, recommending TXA as part of the standard treatment package for all PPH cases. Following this, the use of TXA has been widely adopted globally and increased in Thailand. A recent study at a major Thai university hospital observed a significant increase in TXA administration after 2017. The current study aims to further analyze the recent growth rate of TXA use and its impact on obstetric and perinatal outcomes during cesarean deliveries with PPH.

The Effect of Placental Cord Drainage on the Third Stage of Labor and the Amount of Postpartum Bleeding

The aim of the study was to evaluate the effect of controlled placental cord drainage by opening the clamp at the maternal end after the umbilical cord is cut during birth on the duration of the third stage of labor (departure of the placenta), the amount of blood loss in the third stage, the amount of bleeding in the 2nd hour postpartum, and the development of postpartum complications.

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

This randomised controlled trial aims to evaluate the effectiveness of serious game-based training for postpartum haemorrhage (PPH) management among third-year nursing students. The study employs a pre-test-post-test design with two parallel groups: an experimental group (game-based education) and a control group (traditional education). The sample size was determined by power analysis to be 70 students in total, with 35 students in each group. Participants will be assigned in a 1:1 ratio by computer-assisted block randomisation by a person independent of the research team; students and instructors will not be blinded, but the biostatistician performing the data analysis will be blinded. The intervention group will first receive traditional education, followed by gamification-based education including nursing interventions in the management of PPB; the control group will receive only traditional education. Data will be collected using the PPK Management Knowledge and Skills Assessment Form and the PPK Management Self-Confidence Scale.

Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage

This multicenter study aims to evaluate effectiveness and safety of using the AAJT-S device as a temporary intervention for severe, atony-related PPH that is refractory to standard therapies

Rectal Misoprostol for Reducing Blood Loss in Elective Cesarean Section

This randomized controlled trial aims to evaluate the efficacy of adding preoperative rectal misoprostol to standard oxytocin for reducing intraoperative and postoperative blood loss in women undergoing elective cesarean section. Misoprostol is a prostaglandin E1 analogue that is inexpensive, heat-stable, and effective as a uterotonic agent. The study will compare outcomes between two groups: women receiving oxytocin alone and women receiving oxytocin plus rectal misoprostol. The primary outcome is the reduction of blood loss during and after surgery. Secondary outcomes include changes in hemoglobin levels, need for additional uterotonics, maternal safety, and overall recovery.

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.

Non-invasive Detection of Iron Deficiency in Obstetrics

Validation of non-invasive measurement of zinc protoporphyrin for detection of iron deficiency in pregnancy. In addition, the impact of iron deficiency on the incidence of postpartum depression, restless legs syndrome, obstetric complications and quality of life will be examined.

THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage

The quality improvement project evaluating the delivery of a perioperative care complex intervention to improve haemorrhage-related outcomes in patients undergoing caesarean section. The objectives of the current study will be: 1. To evaluate whether implementation of the 'Rule of THUMB' perioperative complex intervention increases risk assessment, diagnosis and compliance with proven interventions for haemorrhage during and after caesarean section. 2. To understand the influence of contextual and socio-dynamic factors on how the trial results were achieved and how the intervention mechanisms did, or did not, work in practice (the process evaluation). The findings from this study will be used subsequently to modify and improve the quality improvement intervention, so that it can be delivered at scale across Africa and assess its impact on haemorrhage during and after caesarean section in the future.

Intrauterine Balloon (Bakri©) Versus Uterine Tamponade With Chitosan Gauze (Celox PPH©) in the Management of Postpartum Hemorrhage Refractory to Medical Treatmen

Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low- and middle-income countries. It is defined as blood loss of more than 500 mL after vaginal delivery or more than 1000 mL after cesarean section, but severe PPH is typically identified when blood loss exceeds 1000 mL regardless of delivery mode. The initial management of PPH includes the administration of uterotonics such as oxytocin, methylergometrine, and tranexamic acid. However, a subset of patients remains unresponsive to medical therapy, necessitating second-line interventions to avoid escalation to invasive procedures such as uterine artery embolization or peripartum hysterectomy. An intrauterine balloon tamponade device (Bakri©), is commonly used as a mechanical method to control uterine bleeding by exerting direct pressure on the uterine walls. Its use has been widely adopted and incorporated into international guidelines due to its relative ease of use and safety profile. Despite its effectiveness, the failure rate of Bakri balloon placement can range from 20% to 40%, especially in cases of coagulopathy or diffuse atony. Gauzes with a chitosan-based hemostatic dressing (Celox PPH ©) , has been extensively used in trauma settings and is increasingly being explored for surgical and obstetric applications. Its mechanism involves promoting clot formation independent of the clotting cascade, making it potentially beneficial in patients with coagulopathies. Preliminary data and case reports suggest that Celox PPH© may be effective in controlling intrauterine bleeding when used as a packing material after vaginal or cesarean delivery, but no high-quality randomized controlled trial has yet compared it directly with standard interventions. Given the clinical need for alternative second-line treatments for PPH unresponsive to medical therapy, this study proposes a head-to-head comparison of the Bakri balloon and Celox gauze. The findings will help inform evidence-based guidelines and may offer new strategies to reduce maternal transfusion requirements, prevent hysterectomy, and shorten hospital stays in patients experiencing severe PPH.

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. 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.

Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage

To determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage. There have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage. Specific Aim 1: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage. Specific Aim 2: Determine any potential side effects of a double simultaneous uterotonic agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).

Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

Postpartum hemorrhage (PPH) is the most significant leading cause of pregnancy-related mortality in high-risk cesarean delivery women. Systemic autoimmune diseases are associated with adverse pregnancy outcomes (APOs), including PPH, preeclampsia, thromboembolism, abortion, and intrauterine growth restriction. The incidence of PPH in women with systemic lupus erythematosus has been reported to be as high as 34%. Prevention of PPH is the key to reduce complications in high-risk women. In recent years, a large number of clinical studies have confirmed that the early preventive use of tranexamic acid(TXA) can reduce the amount of blood loss, the need for additional uterine contraction agents, the risk of blood transfusion, and maternal adverse outcomes, and do not increase the risk of thromboembolic events, which can be used to prevent PPH. However, the study population of TXA is mainly low-risk puerpera, and there is still a lack of relevant research on TXA used in pregnant women with systemic autoimmune diseases. The purpose of this study was to evaluate the safety and efficacy of TXA in preventing postpartum hemorrhage after cesarean delivery in women with systemic autoimmune disease, as well as the maternal and neonatal risks associated with systemic autoimmune disease, to provide evidence for clinical practice and further research.

The EFFECT of SIMULATION-BASED TRAINING on POSTPARTUM HAEMORRHAGE MANAGEMENT SKILLS

This study was planned to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (VEMS) and hybrid simulation-on postpartum haemorrhage (PPH) management skills in nursing students.

SWIFT - SWIss Factor XIII Trial in PPH

The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII (FXIII) at an early stage of postpartum hemorrhage (PPH). Summary of current body of evidence: * Morbidity and mortality due to PPH is rising. * Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy, despite non-conclusive evidence in all prospective trials. * Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications; a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss. Therefore, this nationwide, multi-center, randomized, controlled trial in multiple perinatal centers across Switzerland will be conducted. The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII. All participating women receive, according to the national guideline, 1g tranexamic acid (TXA) i.v. in case of PPH (measured blood loss \[MBL\] ≥ 500 mL) during the pre-study phase. Randomization takes place if bleeding continues and exceeds 700mL. The intervention group then receives FXIII (Fibrogammin®) according to approved dosage in addition to obstetric standard of care treatment for causes of PPH; the control group receives only standard of care treatment.

Flipped Learning in PPH Education: Impact on Midwifery Students' Knowledge, Skills, Self-Efficacy, and Satisfaction

Maternal death refers to a woman's death due to direct or indirect causes during pregnancy, childbirth, or within 42 days postpartum. Postpartum hemorrhage (PPH) is the leading cause of maternal mortality globally and in our country. Rapid and effective management of PPH is crucial in reducing maternal deaths. WHO, UNFPA, and UNICEF emphasize the critical role of midwives in PPH management, highlighting the importance of enhancing their knowledge and skills during pre-graduate education. Traditional education models are often insufficient for fostering permanent learning, especially in acquiring psychomotor skills like PPH management. In traditional learning, classroom instruction follows a teacher-centered approach, covering only the first two levels of Bloom's taxonomy-knowledge and comprehension-while higher-order cognitive skills such as application, analysis, synthesis, and evaluation are left to individual effort. However, effective and lasting learning requires an active learning environment where students engage more deeply with the material. The flipped learning model addresses these challenges by allowing students to access foundational knowledge outside the classroom and dedicate class time to higher-order skills like discussion, application, and problem-solving. This model enhances learning through technology and interactive face-to-face activities, fostering professional competence in health education. While the flipped learning model is widely used in health education, most studies focus on theoretical knowledge, with limited research on psychomotor skill acquisition. To our knowledge, this study is the first to evaluate the effectiveness of flipped learning in midwifery education for both theoretical and psychomotor skill development. The findings are expected to contribute to advancements in midwifery education and healthcare services.

Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk

Heavy bleeding after childbirth, known as a postpartum haemorrhage (PPH), causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The I'M WOMAN trial is a research study to see whether giving TXA just before childbirth will stop women developing PPH. The trial will assess the effects of intramuscular (IM) and intravenous (IV) tranexamic acid on PPH, side effects and other important maternal health outcomes.