Active clinical trials for "Postpartum Hemorrhage"

In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control. Patients will be randomized to either placebo or ketorolac prior to surgery. Those randomized to ketorolac will receive ketorolac at cord clamp and three additional doses every 6 hours (total 4 doses/24 hours). Those in the placebo group will receive normal saline during those time periods. Our primary outcome is to assess whether intra-operative ketorolac increases the estimated blood loss during Cesarean delivery.

Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries. Postpartum hemorrhage is defined as loss of 500 mL or more in a vaginal delivery and 1 Litre or more in a cesarean delivery.Also any blood loss that cause hemodynamic instability should be considered a PPH. In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included Uterine balloon tamponade as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012. In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH. The reports demonstrated that balloon tamponade is helpful in managing PPH secondary to a wide variety of causes in resource-poor settings. One of the new methods that could be used to control PPH is Uterine packing with chitosan-covered gauze or Celox. Celox Haemostats are dressings with natural material called chitosan to control major haemorrhage including life-threatening bleeding . They are simple and effective, stopping major bleeding.It was first used by military forces to stop sever bleeding in the scene with no other options to stop bleeding. Celox™ granules are actually very high surface area flakes. When they come in contact with blood, Celox™ swells, gels, and sticks together to make a gel like clot, without generating any heat. Celox™ does not set off the normal clotting cascade, it only clots the blood it comes directly into contact with. Celox works on casualties using anticoagulants and anti-platelet therapy such as aspirin .

Postpartum hemorrhage (PPH) is responsible for around 25% of maternal mortality worldwide reaching as high as 60% in some countries.PPH can also be a cause of long-term severe morbidity, and approximately 12% of women who survive PPH will have severe anemia. Postpartum hemorrhage has been defined as blood loss in excess of 500 ml in a vaginal birth and in excess of 1 L in a cesarean delivery.For clinical purposes, any blood loss that has the potential to produce hemodynamic instability should be considered a PPH. However, clinical estimates of blood loss are often inaccurate. Primary (immediate) PPH occurs within the first 24 hours after delivery and approximately 70% of these cases are due to uterine atony. Furthermore, uterine tony is defined as the failure of the uterus to contract adequately after the child is born. Guidelines for the management of postpartum hemorrhage (PPH) involve a stepwise approach including the exclusion of retained products of conception and genital tract trauma. Uterine atony, which is the most common cause, the management of uterine atony is an established stepwise protocol that in many international guidelines. Uterine massage is recommended for the treatment of PPH. Initiate uterine massages soon as excessive bleeding/uterine atony is identified. Intravenous oxytocin alone still is the recommended uterotonic drug for the treatment of PPH. If intravenous oxytocin is unavailable or if the bleeding does not respond to oxytocin, intravenous ergometrine, oxytocin-ergometrine fixed dose or a prostaglandin drug (including sublingual misoprostol, 600 mcg) should be given. The use of intrauterine balloon tamponade is recommended for the treatment of primary PPH due to uterine atony in women who do not respond to uterotonics or if uterotonics are not available. Since 1983, when Goldrath published evidence that inserting a Foley catheter in the uterus and inflating it with water could achieve tamponade, case series and other studies have suggested that various uterine balloon tamponade(UBT) devices may be effective in treating PPH. The studies used various types of UBT devices, including a condom catheter, a Foley catheter, the Sengstaken-Blakemore Esophageal Tube, the Rusch Balloon, and the Bakri Uterine Balloon. In 2007, a systematic review of treatment options for PPH found that 84% success rate of UBT does not significantly vary from surgical treatment outcomes.The World Health Organization (WHO), the International Federation of Gynecology and Obstetrics (FIGO), the American College of Obstetricians and Gynecologists(ACOG), the Royal College of Obstetricians and Gynecologists(RCOG), and the International Confederation of Midwives (ICM) recognize balloon tamponade as a method that could significantly improve the management intractable PPH, especially in low-resource areas. In 2012, WHO updated the guidelines for the management of PPH and retained placenta to include: "The use of intrauterine balloon tamponade is recommended for the treatment of PPH due to uterine atony. This recommendation is now stronger than the previous guidelines. It can be used for women who do not respond to uterotonics or if uterotonics are not available. This procedure potentially can avoid surgery and is appropriate while awaiting transfer to a higher-level facility".Furthermore, FIGO included UBT as a recommended second-line intervention for the treatment of PPH in their updated guidelines issued in 2012. Bakri first published the concept of intrauterine balloon technology in the management of hemorrhage secondary to placenta praevia-accreta during caesarean section with or without bilateral hypo gastric arterial ligation.In 2006, the ACOG Practice Bulletin, published by the American College of Obstetricians and Gynecologists, made mention of the Bakri postpartum balloon for its specifically tailored design that enables conservative management of uterine bleeding in cases of uterine atony and other causes of PPH. The idea of using a condom as a balloon tamponade was first generated and evaluated in Bangladesh by Sayeba Akhter to fill a need and in response to the high cost of commercially available UBT devices.

The purpose of this study is to evaluate the impact of early intrauterine tamponade with a Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal delivery and refractory to first-line uterotonic treatment, ie performed at the same time as second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case of failure of second line uterotonic treatment, on the final severity of PPH. ).

PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH in North America. However oxytocin has a very short duration of action, requiring a continuous infusion to achieve sustained uterotonic activity. Moreover large doses are associated with adverse effects like hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In three studies recently performed at Mount Sinai Hospital, the investigators have found no difference in uterine contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus a larger trial comparing the minimum effective dose determined in the previous three trials with the standard 100 mcg dose is necessary to confirm these findings.

Postpartum hemorrhage (PPH) is the loss of more than 500ml of blood within 24 hours after delivery. It is a major cause of maternal morbidity and mortality across the globe. Oxytocin is a naturally-occurring hormone that causes the uterus to contract, thereby causing labor. A synthetic form of oxytocin is used in obstetric medicine in the same way. It causes the uterus to contract by acting at the oxytocin receptor (OTR). It is used for both the prevention and the treatment of PPH. By causing the uterus to contract, it constricts the blood vessels within it, thus reducing bleeding. Oxytocin is also used to augment labor in women with slow labor progression. Desensitization of the OTR after prolonged exposure to oxytocin occurs, leading to reduced contractions of the uterus with the same doses of oxytocin. This has been demonstrated in previous studies done by the investigators. The resultant need for a higher oxytocin dose to cause adequate uterine contraction has also been demonstrated in laboring women having received oxytocin for labor augmentation. Magnesium sulphate (MgSO4) is widely used within obstetric medicine. It is used for seizure prevention and treatment in preeclampsia and eclampsia, and is used for fetal neuroprotection in preterm labor, to reduce the risk of cerebral palsy. It is well-known to have a relaxant effect on uterine muscle, and as such, has been used as a tocolytic agent in preterm labour to prevent premature contractions and premature delivery. The effect of MgSO4 on contractions in oxytocin pre-treated myometrium has not been fully elucidated with human lab studies. There are suggestions it may lead to increased oxytocin requirements or increased postpartum hemorrhage (PPH) in preeclamptic patients. This bears significance in the preeclamptic and eclamptic populations who are likely to be receiving MgSO4 in combination with oxytocin. The investigators hypothesize that MgSO4 will reduce uterine contractions in oxytocin pre-treated myometrium, as well as untreated myometrium, and higher oxytocin doses will be needed to produce equivalent contractions. This will help us to better understand the implications of the use of these drugs together in the clinical setting.

The purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. The drugs studied--uterotonics--are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst common uterotonic drugs, namely oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown. The investigators will be testing isolated uterine muscle samples to increasing concentrations of these four drugs in three patient populations: non-laboring, laboring without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients, and all four drugs will induce different patterns of contractions.

The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin & ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.

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: Control group: 100 mL 0.9% normal saline (NS). 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).

The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery. This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.