Carbetocin 100micrograms/1ml solution for injection pre-filled syringes

Abstract Objectives To assess the value of carbetocin in prevention of postpartum hemorrhage (PPH) after Cesarean delivery (CD). Search strategy Screening of PubMed, Web Of Science, Scopus, register clinical trials registry and Google scholar from inception to December 2023. The keywords used included postpartum hemorrhage, intraoperative blood loss, postoperative blood loss, Cesarean delivery and their MeSH terms. Selection criteria All RCTs that compared carbetocin to oxytocin in women undergoing CD with risk factor for PPH. Fourteen studies including 3068 participants. Thirteen were written in English and one in Polish. Data collection and analysis The extracted data included location of the trial, number of centers involved in recruitment, the number of participants and their characteristics, details of the study groups and dose time and route of intervention and its comparator, primary and secondary outcome parameters and trial registration number and timing in relation to patients recruitment. The evaluated outcomes parameters included intraoperative and 1st 24 h post-operative blood loss, PPH, the hemoglobin changes after the procedure, the need for any additional uterotonic agents, surgical interventions or blood transfusion and drugs side effects. Main results Blood loss during the 1st 24 h after CD was evaluated in 11 studies with 2497 participants and revealed a mean difference (MD) of −111.07 with 95% CI of [−189.34 and −32.80 ( P = 0.005, I 2 97%). The hemoglobin changes after the operation was evaluated in 8 studies with 1646 participants and revealed a MD of −0.46 with 95% CI of −0.14 and −0.79 ( P = 0.03, I 2 96%). The incidence of PPH > 500 ml was reported in 8 studies with 1787 participants and revealed an Odd Ratio (OR) of 0.52 with 95%CI of [0.36, 0.77] ( P < 0.001, I 2 0%). The need for additional uterotonic agents was evaluated in 12 studies with 2663 participants and revealed an OR of 0.17 with 95% CI of 0.07 and 0.37 ( P < 0.001, I 2 88%). The need for blood transfusion was evaluated in 10 studies with 2439 participants and revealed an OR of 0.27 with 95% CI of 0.12 and 0.57 ( P < 0.001, I 2 20%). The need for additional interventions was evaluated in 3 studies with 1311 participants and revealed an OR of 0.67 with 95% CI of 0.28 and 1.60 ( P = 0.37, I 2 59%). Conclusion Carbetocin decreased the blood loss during the 1st 24 h after CD, post-operative hemoglobin drop, PPH the need for additional uterotonic agents and blood transfusion when compared to oxytocin.

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BACKGROUND: Preventing postpartum haemorrhage (PPH) is a significant concern because of its effect on maternal morbidity and mortality. PPH is leading cause of maternal death in developing countries and also globally. AIM: Evaluation of safety and efficacy of carbetocin versus oxytocin for PPH prevention in caesarean deliveries. METHODS: Double blind randomised controlled trial carried for one year. 42 pregnant patients included in study, who underwent caesarean section and fulfilled inclusion criteria. Patients divided into two groups A and B with 21 in each group, with the help of computer generated random number, group A recieved 100 microgram of carbetocin through intravenous route and 1 ml of normal saline given intramuscularly as placebo, group B received 10 IU oxytocin through intramuscular route and 1 ml of normal saline is given intravascular. RESULT: Mean age was 25.19 years±3.86 years and 24.76 years±3.93 in group A and group B respectively. Mean blood loss significantly reduced in carbetocin compared to oxytocin with significant p value 0.006, haemoglobin deficit was less in group A as we compare with group B having p value 0.052 whereas incidence of PPH in group A was 4.76 % and group B was 19.05% and had p value of 0.343, not significant. Effect of both medication on blood loss varies significantly across different BMI categories. CONCLUSION: Observation shows equal efficacy and safety of both carbetocin and oxytocin in prevention of postpartum haemorrhage in caesarean section but carbetocin is considered as uterotonics of crucial importance due to heat stability in poor resource settings, therefore use of carbetocin could be better in comparison to oxytocin in PPH prevention.

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Prophylactic use of uterotonic is a universal practice in vaginal and cesarean delivery. Heat stable carbetocin is a relatively new uterotonic. Lower doses of uterotonics are as effective as standard doses in elective cesarean deliveries. This study aimed to compare the effectiveness and safety of 50 mcg carbetocin (lower dose) to 100mcg carbetocin (standard dose) for the prevention of postpartum hemorrhage during elective cesarean delivery. A total of 212 term pregnant women were randomized to two group. Group I received 50 mcg of carbetocin and Group II received 100 mcg of carbetocin. The blood loss, tone of the uterus, use of additional uterotonics or styptics, requirement of blood transfusions and adverse effects of the drug in both the groups were compared. There were no statistically significant differences in both the groups with respect to blood loss, uterine tone, blood transfusions or additional use of uterotonics or styptics.(p>0.05). : A lower dose of 50 mcg is as effective as the standard dose of 100 mcg of carbetocin in elective caesarean delivery in preventing post-partum hemorrhage.

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Purpose: Intrathecal fentanyl improves intraoperative analgesia and reduces hypotension by enhancing subtherapeutic local anesthetic doses during cesarean sections. This study explores whether these advantages are affected by the negative circulatory effects of carbetocin after delivery. Patients and Methods: This randomized double-blind, non-inferiority trial was conducted at a tertiary hospital in China. Sixty patients who underwent cesarean section, with singletons, were randomly assigned to receive either spinal anesthetic 15 mg ropivacaine combined with 10 μg fentanyl (Group F) or 16.5 mg ropivacaine (Group R). Slow intravenous carbetocin was routinely administered after delivery. Primary outcomes included hypotension incidence and anesthesia success rate (non-inferiority margin of 0.20). Secondary outcomes included analgesic supplementation time after anesthesia, vasopressor use, neonatal outcomes, patient satisfaction with anesthesia and postoperative analgesia, and adverse event incidence. Results: The incidence of hypotension in Groups F and R was 73.3% and 96.7%, and the success rate of anesthesia was 93.3% and 66.7%, respectively. Compared with Group R, Group F showed superior results in terms of the incidence of hypotension (difference: − 23.3%; 95% confidence interval [CI], − 40.4 to − 6.2; P superiority 2-sided < 0.05) and the success rate of anesthesia (difference: 26.6%; 95% CI, 7.5 to 45.7; P superiority 2-sided < 0.05). Group F experienced longer pain relief, required less vasopressors, and reported less transient chest tightness. No significant differences were observed in other outcomes. Conclusion: Low-dose ropivacaine combined with fentanyl remains a recommended choice for spinal anesthesia in cesarean sections, alongside carbetocin administration. Keywords: cesarean section, hypotension, fentanyl, spinal anesthesia

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Introduction: Caesarean Section (CS) is a common obstetric procedure associated with the risk of intraoperative bleeding, necessitating the use of uterotonic agents such as oxytocin and carbetocin to reduce blood loss. Need of the Study: Given the clinical significance of intraoperative bleeding during CS and the potential implications for maternal outcomes, there is a need for well-designed comparative studies. Therefore, the present study was planned to address this gap in the literature by comparing the efficacy of oxytocin and carbetocin in reducing intraoperative bleeding during CS. Aim: To evaluate and compare the effectiveness of oxytocin versus carbetocin in reducing intraoperative bleeding during caesarean sections. Materials and Methods: A prospective, randomised, doubleblind controlled trial will be conducted at the Department of Anaesthesiology, Jawaharlal Nehru Medical College (JNMC), Datta Meghe Institute of Higher Education and Research, Sawangi (M), Wardha, Maharashtra, India from October 2024 to March 2026. One hundred female patients aged 18-35 years with American Society of Anaesthesiologists (ASA) grade I and II, scheduled for CS under spinal anaesthesia, will be included in the study and divided into the oxytocin and carbetocin groups during CS. The amount of blood loss exceeding 1000 mL during CS, haemodynamic changes, the requirement for vasopressors and antifibrinolytics and the duration of surgery will be assessed between the two groups. Statistical analysis will be conducted using experimental and inferential statistics, including the Chisquare test, Student’s paired and unpaired t-tests and Tukey test, with a significance level set at p&lt;0.05.

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Introduction: Postpartum haemorrhage (PPH) remains a leading global cause of maternal deaths, with over 70,000 annual deaths. Low- and middle-income countries disproportionately bear this burden, often due to compromised cold chains for oxytocin and insufficient staff training. Methods: This review synthesized thirty publications on heat stable carbetocin (HSC) published from January 2018-March 2025. Eligible studies include randomized trials, systematic and narrative reviews, cost or economic evaluations, and implementation studies. Study findings were categorized into clinical efficacy and safety of HSC, cost-effectiveness, and adoption barriers and facilitators from field implementation, and sustainability strategies. Results: Several large-scale trials, especially the CHAMPION trial, demonstrated that HSC is clinically non-inferior to oxytocin. In a pilot study from Nigeria (n = 18,364 deliveries), 56% of women received HSC for PPH prevention and PPH incidence dropped to 0.8%. Cost models from India estimated that HSC could prevent about 5,500 additional PPH cases and save five maternal lives per 100,000 births when priced comparably to oxytocin. Programs in Kenya and conflict-affected South Sudan achieved >90% coverage of HSC by implementing WHO policy updates, pooled procurement, simulation drills for frontline health workers, and appointing "PPH champions". Awareness of uterotonics and PPH danger signs among postpartum women increased from 48% to 81% after community-based intervention in Kenya. The thermostability of HSC (up to three years without refrigeration at a temperature of ≤30°C) addresses gaps in cold chain associated with oxytocin and reduces wastage from degradation. Integrating HSC with tranexamic acid and other postpartum haemorrhage bundle elements further improved maternal outcomes. Conclusion: Heat-stable carbetocin offers a viable, cost-effective uterotonic strategy in LMIC settings. Consistent training, supportive supervision, regulatory oversight, and domestic funding, including private sector investment, are critical to achieving widespread adoption of HSC in LMIC. Expanding HSC across resource-limited settings could substantially reduce PPH-related deaths and accelerate maternal survival goals.

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In Uganda, postpartum haemorrhage (PPH) is responsible for 34% of all institutional maternal deaths. Injectable oxytocin is the preferred uterotonic for prevention of PPH. However, in resource-limited settings, the effectiveness of oxytocin is sub-optimal due to efficacy, quality (cold chain storage requirements), and manufacturing standards (poor quality active pharmaceutical ingredients, lack of sterile manufacturing environment, and low-quality manufacturing processes). This study aimed to assess the cost-effectiveness of heat-stable carbetocin, a quality uterotonic newly recommended by WHO and Ugandan Ministry of Health, compared to standard uterotonics for the prevention of PPH in Uganda. A decision tree model was built to assess the cost-effectiveness of heat-stable carbetocin compared to the current standards of care - oxytocin, misoprostol or oxytocoin+misoprostol combination. The model was applied to a hypothetical annual cohort of birthing women eligible for PPH prevention in Uganda's public health facilities. The evaluation considered direct costs and health outcomes using a public health perspective. The model inputs were obtained through literature review and, whenever referencable information was unavailable or incomplete, from key opinion leaders. Compared to oxytocin, administering heat-stable carbetocin to prevent PPH had a cascading favorable effect and was estimated to avert 57,536 PPH cases, 123 maternal deaths, and 4,203 disability-adjusted life years (DALYs). Heat-stable carbetocin is also cost-saving where the direct cost to the public healthcare system was lower by USD $1,058,353 (UGX 3,998,350,875). The benefits of heat-stable carbetocin were even greater when compared with misoprostol (averted 73,939 PPH events, 273 maternal deaths, and 8,716 DALYs, and lowered public healthcare system costs by USD $2,118,372 [UGX 8,002,996,052]). Heat-stable carbetocin for preventing PPH in Uganda has the potential to reduce PPH events, and subsequently maternal deaths, DALYs, and costs for the public healthcare system. Adopting heat-stable carbetocin will contribute towards achieving the country's Sustainable Development Goal 3.1.

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