View clinical trials related to Postpartum Hemorrhage.
Filter by:This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission. Written informed consent will be obtained from the patients by the Co-principal investigator and by the study collaborators. If patients agree to participate, a CBC (complete blood count) will be obtained via venous puncture routine in our facility as part of the admission labs which will be around 10 cc of blood. The device will be used during the delivery in laboring room. The device will be used to assess QBL (quantitative blood loss) by the research staff only and results/ QBL assessment will be masked to the clinical team. Unmasking will only occur following study completion with purpose to perform data analysis. Patient management will be according to the clinical team without the knowledge of the QBL. All patients undergo a CBC postpartum as part of post-partum evaluation, this will also be performed by venipuncture where 10 cc of blood will be collected. The drop in Hgb (hemoglobin) between the pre and post partum CBCs will be calculated for each patient. The post-partum CBC will be collected approximately 24-30 hours from delivery as standard in our unit. The blood will be collected from each patient by the nursing staff who are experienced in withdrawing blood. Patients will be divided into quartiles of Hgb. Cases will be those patients whose Hgb is in the upper quartile, while controls will be those patients whose Hgb is in the lower 3 quartiles. We will be comparing visual EBL (estimated blood loss) by standard clinical assessment versus the QBL result from the device between cases and controls. The Triton L&D (labor and delivery) system which comprises of the device, software analysis and staff training will be supplied by the manufacturer free of charge. Research staff will be trained by the manufacturer. We will be offering our skills, fellows, midwifes and residents, who will be collecting data and we will be performing the data analysis. Results will be available to the manufacturer after results are completed. The results of this study will be presented in conferences or published in a peer-review journal. Demographic information will be obtained from the electronic medical record. The data will be kept on a password secured University of Texas Medical Branch (UTMB) computer. An encrypted USB flash drive will be used to transfer data. The data will be identified and linked to the patient using the medical record number. During data analysis, all patient identifiers will be deleted.
The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the likelihood of postpartum endometritis.
This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss. Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta. We hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.
The aim of this study is to evaluate the impact of a rotational thromboelastometry (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or cesarean delivery. Maternal transfusion requirement, quantitative blood loss (QBL), need for intensive care unit (ICU) admission, and length of hospital stay will be evaluated. The utilization of ROTEM® for transfusion management will identify patients who develop early coagulation changes such as hypofibrinogenemia or disseminated intravascular coagulation. Our hypothesis is that earlier identification and directed therapy of such coagulation changes will lower overall transfusion requirement (packed red blood cells, fresh frozen plasma, fibrinogen concentrate, cryoprecipitate, or other product), reduce the need for ICU admission, and shorten length of hospital stay. A cost analysis will be performed.
The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study is being conducted to further assess safety and tolerability of inhaled oxytocin, and to characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active management of the third stage of labour (after the baby is born). Group 2 will enroll non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the safety and tolerability of IH and IV oxytocin.
This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females undergoing a caesarean section. Two administrations of oxytocin will be tested, after which uterine contractility will be assessed.
The main objective of this project is to assess the average cost of the treatment of bleeding postpartum with recombinant activated factor VII (NovoSeven®) and compare it to the reference strategy. Costs related to medicine NovoSeven® can generate surplus, but it also avoids in some cases very costly invasive procedures. It will be interesting to compare the average cost of the complete strategies supported.
The purpose of the study is to evaluate the safety, feasibility and applicability of a new device 'Tampostat' in the management of primary postpartum hemorrhage and compare the efficacy of 'Tampostat' in terms of arresting primary PPH with that of the conventional condom catheter.
The aim of this study is to characterize the coagulation changes, using thromboelastography (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically, TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo before surgery, during elective cesarean delivery, and 2 hours postpartum. Postpartum hemorrhage (PPH) is increasing in incidence in the United States, renewing interest in multimodal approaches to blood conservation during cesarean delivery. Pharmacologic therapy with the antifibrinolytic agent, tranexamic acid (TA), has been shown to reduce estimated blood loss (EBL) during cesarean delivery, but its effect on global coagulation as assessed by TEG, and how this correlates with lowering blood loss, has not been elucidated. This study will be conducted as a randomized, double-blind, controlled trial with two study arms: control (60 patients); and treatment (60 patients). Subjects will be pre-medicated with routine pre-cesarean delivery medications including oral sodium citrate 30 mL and intravenous (IV) metoclopramide 10 mg. A peripheral IV and noninvasive hemoglobin monitor will be placed, and baseline labs sent: type and screen, serum hemoglobin, platelet count, fibrinogen, activated partial thromboplastin time (aPTT), prothrombin time (PT), and baseline TEG values (r time, k time, alpha angle, and maximum amplitude). Patients will have blood pressure, heart rate, and pulse oximetry measured throughout surgery as per standard of care. Patients will all receive IV lactated Ringers' (LR) solution prior to surgery and throughout surgery, with volume recorded and a goal of less than 2 L unless more IV fluid is clinically indicated. All patients will have a spinal anesthetic as per standard of care, with hyperbaric bupivacaine 12 mg, fentanyl 10 μg, and hydromorphone 100 μg. If the anesthetic plan is altered (combined spinal-epidural, general anesthesia conversion, general anesthesia planned), indications and medication doses used will be noted for analysis. Immediately following induction of anesthesia and prior to skin incision, infusion of study solution will be initiated. Study solutions will consist of: 1. Control group: 100 mL 0.9% normal saline (NS). 2. Treatment group: 100 mL 0.9% NS containing 1g tranexamic acid (TA). Study solution will be infused via an infusion pump over 10 minutes. Blood loss will be measured by visual estimate and weight of surgical sponges. Noninvasive hemoglobin will be measured throughout the study. All routine care lab values will be noted. At minimum, one lab panel will be sent one hour after study solution initiation (hemoglobin, fibrinogen, platelet count, aPTT, PT, and TEG).
This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm. The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.