Oxytocin versus carbetocin at elective Cesarean delivery in parturients with class III obesity: a double-blind randomized controlled noninferiority trial Class III obesity (body mass index [BMI] ≥ 40 kg·m) is associated with high rates of Cesarean deliveries and postpartum hemorrhage, with increased maternal and fetal morbidity. The doses of oxytocin and carbetocin are two to four times higher at Cesarean delivery in patients with class III obesity. We sought to investigate the efficacy of carbetocin 80 µg iv compared with oxytocin 1 IU iv (plus infusion) at elective Cesarean delivery in parturients with class III obesity. We hypothesized that, with equipotent dosing, carbetocin would be noninferior to oxytocin. We conducted a randomized, double-blind, noninferiority study in nonlabouring, term
Intramyometrial and intravenous oxytocin compared to intravenous carbetocin for prevention of postpartum hemorrhage in elective cesarean section-A quasi-randomized controlled phase IV non-inferiority interventional trial. Our objective was to assess non-inferiority of the unique approach used in our institution of combined 10 IU IM (intramyometrial) and 10 IU IV (intravenous) oxytocin to carbetocin IV in preventing severe postpartum blood loss in elective cesarean sections. The design was a prospective controlled phase IV non-inferiority interventional trial. The setting was a tertiary center at University Hospital, Zurich, Switzerland. The population consisted of 550 women undergoing elective cesarean section after 36 completed weeks of gestation at low risk for postpartum hemorrhage (PPH
A randomized controlled trial on the comparison of two doses of carbetocin with oxytocin for the prevention of postpartum hemorrhage (concert trial). To compare the effectiveness of 50 and 100 μg of carbetocin with 10 IU of oxytocin for the prevention of postpartum hemorrhage (PPH). This was a triple-blind, non-inferiority trial involving pregnant women recruited at term. We compared two doses of carbetocin (50 and 100 μg) with 10 IU of oxytocin administered as uterotonic agent after vaginal or cesarean delivery. Uterine contractility was assessed at 2- and 5-min after uterotonic administration. The association between adequate uterine tone and PPH with the patients' characteristics were examined using the chi-square test. Effect of the drugs on the odds of developing PPH was examined using
Cost-effectiveness analysis of carbetocin for prevention of postpartum hemorrhage in a low-burden high-resource city of China. Postpartum hemorrhage (PPH) is a major cause of maternal morbidity, and oxytocin is the first-line uterotonic agent for PPH prevention. Clinical findings have reported carbetocin to reduce PPH risk without increasing risk of important side effects. Hong Kong is a low PPH burden and high-resource city in China. We aimed to examine the cost-effectiveness of PPH prevention with carbetocin from the perspective of Hong Kong public healthcare provider. A decision-analytic model was developed to simulate clinical and economic outcomes of carbetocin and oxytocin for PPH prevention in a hypothetical cohort of women at the third stage of labor following vaginal birth
Retracted: Carbetocin Controls Intraoperative Blood Loss and Thickness of Myometrium in Scar Uterus Cases. [This retracts the article DOI: 10.1155/2022/5477432.].
Heat stable carbetocin or oxytocin for prevention of postpartum hemorrhage among women at risk: A secondary analysis of the CHAMPION trial. To examine whether the observed non-inferiority of heat-stable carbetocin (HSC), compared with oxytocin, was influenced by biologic (macrosomia, parity 3 or more, or history of postpartum hemorrhage [PPH]) and/or pharmacologic (induction or augmentation
Cost-effectiveness and budget impact of heat-stable carbetocin compared to oxytocin and misoprostol for the prevention of postpartum hemorrhage (PPH) in women giving birth in India. Low- and middle-income countries (LMICs) are committed to achieving the Sustainable Development Goal 3.1 to reduce maternal mortality. The Ministry of Health and Family Welfare of India recommends prophylactic uterotonic administration to every woman following delivery to reduce the risk of postpartum hemorrhage (PPH), as PPH is the leading cause of maternal mortality in LMICs, including India. In 2018, the World Health Organization first recognized heat-stable carbetocin for PPH prevention. Governments are now considering its introduction into their public health systems. A decision-tree model was developed
Intranasal Carbetocin Reduces Hyperphagia, Anxiousness and Distress in Prader-Willi Syndrome: CARE-PWS Phase 3 Trial. Prader-Willi syndrome (PWS) is a rare genetic disorder characterized by endocrine and neuropsychiatric problems including hyperphagia, anxiousness and distress. Intranasal carbetocin, an oxytocin analog, was investigated as a selective oxytocin replacement therapy. To evaluate safety and efficacy of intranasal carbetocin in PWS. Randomized double-blind placebo-controlled phase 3 trial with long-term follow-up. 25 ambulatory clinics at academic medical centers. 130 participants with PWS aged 7-18. Participants were randomized to 9.6 mg/dose carbetocin, 3.2 mg/dose carbetocin, or placebo TID during an 8-week placebo-controlled period (PCP). During a subsequent 56-week long
Cardiovascular effects of oxytocin and carbetocin at cesarean section. A prospective double-blind randomized study using noninvasive pulse wave analysis. Oxytocin is routinely administered after delivery for prophylaxis and treatment of postpartum hemorrhage, but it is associated with considerable cardiovascular side-effects. Carbetocin, a synthetic oxytocin analogue, has a myometrial contraction effect of 60 min when given IV, compared with 16 min for oxytocin. To investigate whether there are differences in cardiovascular effects between oxytocin and carbetocin up to 1 h after treatment. Sixty-one healthy pregnant women undergoing elective cesarean section in spinal anesthesia were randomized to receive an IV bolus of either five units (8.3 µg) of oxytocin or 100 µg of carbetocin after
Effects of carbetocin combined with ergometrine maleate on blood loss and coagulation function of puerperae with postpartum haemorrhage. To determine the effects of carbetocin combined with ergometrine maleate on blood loss and coagulation function of puerperae with postpartum haemorrhage (PH). In this retrospective study, the clinical data of 102 puerperae with PH treated in Harbin Red Cross Central Hospital from March 2019 to February 2022 were analyzed. Among them, 45 puerperae treated with carbetocin alone were assigned to the control group, and the other 57 treated with carbetocin combined ergometrine maleate were assigned to the observation group. After treatment, the blood loss, hemostasis time, changes of coagulation function and hemodynamic indexes, efficacy and incidence of adverse
Hemodynamic Effects of Oxytocin and Carbetocin During Elective Cesarean Section in Preeclamptic Patients Under Spinal Anesthesia: A Randomized Double-blind Controlled Study. Oxytocin and carbetocin are uterotonic medications that are used to decrease postpartum hemorrhage (PPH). However, there are not enough clinical data about the hemodynamic side effects of carbetocin. This study aimed to compare carbetocin and oxytocin hemodynamic effects in preeclamptic patients undergoing elective cesarean section under spinal anesthesia. In this double-blind, randomized controlled trial, intravenous oxytocin or carbetocin was administered to 80 women (40 per group). The hemodynamic effects, such as blood pressure (BP), heart rate (HR), and oxygen (O) saturation, were measured before the operation
Carbetocin versus Oxytocin with or without Tranexamic Acid for Prophylactic Prevention of Postpartum Hemorrhage after a Vaginal Delivery: A Randomized Clinical Trial. Our study's primary objective was to examine the effects of four different prophylactic protocols on the prevention of postpartum hemorrhage following vaginal birth, including carbetocin only, oxytocin only, and a combination of carbetocin or oxytocin with tranexamic acid. A multicentric randomized controlled trial. This multicentric center prospective randomized controlled trial was conducted at the Department of Obstetrics and Gynecology of Bezmialem University and Van Health Teaching and Research Hospital from August 2022 to January 2023. The collected data included age, gravidity, parity, gestational age at birth, duration
Comparison of carbetocin as a bolus or an infusion with prophylactic phenylephrine on maternal heart rate during Cesarean delivery under spinal anesthesia: a double-blinded randomized controlled trial. Carbetocin, an oxytocin analog, given as a postpartum hemorrhage prophylaxis in elective Cesarean deliveries, frequently causes tachycardia and hypotension. Phenylephrine infusion has been shown to prevent spinal anesthesia-induced hypotension. The goal of this study was to evaluate if a slow infusion of carbetocin would reduce maternal heart rate variation and hemodynamic disturbances compared with a rapid bolus in parturients receiving a prophylactic phenylephrine infusion during elective Cesarean delivery. In this double-blinded randomized controlled trial, 70 healthy parturients were allocated
Effect of heat stable carbetocin vs oxytocin for preventing postpartum haemorrhage on post delivery hemoglobin-a randomized controlled trial. To compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level. Hospital based study in Southern India. Women delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India. WHO CHAMPION Trial was a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin with oxytocin administered immediately after vaginal birth in women across 23 sites in 10 countries. This was a nested randomized controlled trial designed to compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM, administered within one
Comparison of Oxytocin vs. Carbetocin Uterotonic Activity after Caesarean Delivery Assessed by Electrohysterography: A Randomised Trial. Electrohysterography has been used for monitoring uterine contractility in pregnancy and labour. Effective uterine contractility is crucial for preventing postpartum haemorrhage. The objective of our study was to compare postpartum electrohysterograms in women receiving oxytocin vs. carbetocin for postpartum haemorrhage prevention after caesarean delivery. The trial is registered at ClinicalTrials.gov with the identifier NCT04201665. We included 64 healthy women with uncomplicated singleton pregnancies at term scheduled for caesarean section after one previous caesarean section. After surgery, a 15 min electrohysterogram was obtained after which women were
Carbetocin Controls Intraoperative Blood Loss and Thickness of Myometrium in Scar Uterus Cases. To study the effect of carbetocin on intraoperative blood loss and thickness of myometrium during cesarean section with the scarred uterus at term pregnancy. Pregnant women with full-term gestational scar uterus who underwent cesarean section from March 1, 2021, to April 30, 2022, were retrospectively collected and divided into a reference group (using oxytocin) or a study group (using carbetocin). The clinical data of the two groups were retrospectively analyzed, and the operation time, intraoperative blood loss, hospital stay, uterine contraction effect, changes in the myometrium, and complications were compared between the two groups. A total of 103 pregnant women were retrieved. There were 44 cases
Carbetocin vs. oxytocin at elective caesarean delivery: a double-blind, randomised, controlled, non-inferiority trial of low- and high-dose regimens. Carbetocin or oxytocin are given routinely as first-line uterotonic drugs following delivery of the neonate during caesarean delivery to prevent postpartum haemorrhage. Low doses may be as effective as high doses with a potential reduction in adverse effects. In this double-blind, randomised, controlled, non-inferiority trial, we assigned low-risk patients undergoing elective caesarean delivery under spinal anaesthesia to one of four groups: carbetocin 20 μg; carbetocin 100 μg; oxytocin 0.5 IU bolus + infusion; and oxytocin 5 IU bolus + infusion. The study drug was given intravenously after delivery of the neonate. Uterine tone was assessed
Exploring cardiac effects after oxytocin 2.5 IU or carbetocin 100 μg: A randomised controlled trial in women undergoing planned caesarean delivery. Oxytocin can stimulate release of myocardial biomarkers troponin I and T, prolong QTc and induce ST-depression. To explore cardiac changes after either intravenous carbetocin or oxytocin. Exploratory phase 4 randomised controlled trial. Obstetrics units of Oslo University Hospital, Norway between September 2015 and May 2018. Forty healthy, singleton pregnant women aged 18 to 50 years at gestational age at least 36 weeks with a planned caesarean delivery. Participants were randomised to receive either oxytocin 2.5 IU or carbetocin 100 μg immediately after delivery. The primary endpoint was the assessment of troponin I within 48 h of study drug