View clinical trials related to Post Partum Hemorrhage.
Filter by:Background Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum haemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda. Large parts of the monitoring of mothers during active management of third stage of labour is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. A balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of balloon occlusion time including repeated short balloon deflations. Objective To assess the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda. Study design, setting and population A phase IIb/III, open label, 1:1 randomized clinical trial will be conducted at Kawempe National Referral Hospital, Kampala, Uganda, to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care. The inclusion criteria are: a) women with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg, b) written consent. The exclusion criterion is prior cardiac arrest or intra-abdominal pregnancy. The sample size of the trial will be 212 participants. Enrolment will follow a group sequential design approach with two interim analyses at 50% and 85% of the total sample size, and a final analysis with full sample size. Utility of the study It is crucial to explore alternative modalities that could prevent adverse maternal outcomes in life-threatening postpartum haemorrhage in Uganda and the rest of the world.
A Randomized Controlled Non inferiority Trial will be conducted to see the feasibility, acceptability and efficacy of S-Condom Uterine Tamponade in women with atraumatic PPH and not responding to first line of treatment.
Caesarean delivery is inevitably associated with a higher amount of blood loss vis-à-vis primary postpartum haemorrhage, when compared to vaginal delivery. Oxytocin use in tropical developing countries for the reduction blood loss at caesarean section have been met with challenges of ineffectiveness due to poor transportation, inadequate storage and drug adulteration. Therefore, there is a need for an effective, temperature stable uterotonic with a lesser risk of adulteration. The study is aimed at evaluating the effectiveness and safety of adjunctive sublingual misoprostol in reducing intraoperative blood loss at caesarean section.
Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus. After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship. The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.
In part 1 of the study, the investigators conducted a prospective, open-label, dose finding pharmacokinetic (PK) study in 43 pregnant 3rd trimester women scheduled for non-emergent cesarean section. The investigators administered three doses of the drug (5 mg/kg, 10 mg/kg and 15 mg/kg) in an escalating fashion by cohort with the lowest dose first. The drug was administered intravenously at the time of umbilical cord clamping for a non-emergent cesarean section. A maximum of 1 gram was administered. TXA serum levels at several time points after delivery were assayed to see if they reach the target plasma concentration of 10 microg/mL. A PK model was constructed for determining the optimal TXA dose administered at parturition. In part 2 of the study, the investigators aim to compare PKPD endpoints using prophylactic TXA via IV and IM routes administered pre-cord clamp. The investigators will administer 1000 mg TXA within 10 minutes of skin incision via intravenous infusion (up to n=15), intravenous bolus < 2 minutes (up to n=15) and intramuscular injection (up to n=15). The investigators will target women undergoing scheduled cesarean delivery greater than 34 weeks gestation, women undergoing vaginal delivery > 34 weeks of gestation and morbidly obese women (BMI>50) undergoing either a vaginal or cesarean delivery. The investigators will use advanced modeling techniques to determine time to achieve PKPD targets and duration remaining at those targets. The goal will be to determine how the optimal dose may vary if route of administration is modified. The investigators plan to enroll 45 patients in addition to the 43 that were enrolled during part 1. Our goal is to 30 participants, but the investigators will enroll 45 to account for lost to follow-up. The investigatorsalso aim to enroll 30 patients undergoing vaginal delivery and 30 morbidly obese women (BMI > 50) undergoing either a vaginal or cesarean delivery but the investigators will enroll 45 patients for each of these groups to account for loss to follow up. In addition, the investigators will enroll 30 pregnant patients receiving no medication acting as the control group, but the investigators will enroll 45 to account for loss to follow up.
The goal of this clinical trial is to test if manual external aortic compression can prevent heavy blood loss in cesarean section. The main question[s] it aims to answer are: 1. Is external aortic compression safe? 2. Is external aortic compression effective? Participants will receive preventive external aortic compression or no external aortic compression right after the baby is out at cesarean section. Blood loss will be measured, as well as kidney function, hemoglobin, and hematocrit before and after the operation. Experienced discomfort will be assessed the day after surgery and breastfeeding and signs of depression will be assessed using questionnaires after 2 months. Researchers will compare women with and without external aortic compression to see if there are differences in these outcomes.
Postpartum haemorrhage remains at the top of the causes of maternal deaths in both developed and developing countries .
PPH is commonly defined as blood loss exceeding 1000 milliliters after vaginal birth or cesarean section.1 PPH is often classified as primary/immediate/early (occurring within 24 hours of birth) or secondary/delayed/late (occurring from more than 24 hours postbirth to up to 12 weeks postpartum).. Atonic post-partum haemorrhage is one of the most challenging complications of normal delivery process . There are many maneuveurs applied to the atonic uterus for controlling the blood loss and conserving the uterus from hysterectomy process . There are pharmacological and surgical methods to control the bleeding . In this study , Mostafa Maged technique is to prevent and control post-partum bleeding during vaginal delivery . It is so simple and not-costly method .
Postpartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the most commonly used uterotonic drug for the active management of third stage labor, to reduce the risk of PPH and help deliver the placenta. Carbetocin is currently recommended by the SOGC (Society of Obstetricans & Gynecologists of Canada), and is a relatively newer drug with a longer duration of action. It has been previously demonstrated that women with elevated BMI require higher doses of these drugs to induce adequate uterine contraction and dose finding studies undertaken at Mount Sinai Hospital have shown that the ED 90 in obese patients to be carbetocin 80 mcg and oxytocin 1IU. Furthermore, previous studies have indicated that the use of carbetocin over oxytocin in non-obese popultion is associated with reduced bleeding and requirement of additional uterotonic medications. No study has directly compared the two drugs in obese parturients in a head to head clinical trial; therefore a double-blind randomized controlled trial is necessary to show the non-inferiority of carbetocin against the current standard of care at Mount Sinai hospital, which is oxytocin.
306 patients will be divided randomly in to 2 GROUPS: - control group: 153 patients will receive Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM and waiting for signs of placental separation then controlled cord traction (CCT) to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver) - study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied. In the maneuver,sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end. Massage is not employed but the fundus is frequently palpaple to insure it doesnot become atonic and filled with blood from placenta separation. In cases whom placental separation did not occur within the 90 seconds, we removed the ovum forceps and waited for 30 min for the placental separation .