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Oxytocin 2018-11-19 ClinicalTrials

Carbetocin ED90 sought for preventing postpartum hemorrhage in obese C-section patients

Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2

Background

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality, often requiring uterotonics. While oxytocin is common, Carbetocin, an oxytocin analog, offers a superior pharmacokinetic profile with a longer duration of action. Previous research showed that lower doses of Carbetocin (14.8 mcg) were effective for women with BMI < 40 kg/m2. However, maternal obesity (BMI ≥ 40 kg/m2) significantly increases the risk of PPH, creating a critical knowledge gap regarding optimal Carbetocin dosing for this high-risk population.

Study Design

This abstract describes the rationale and design for a planned dose-finding study. The investigators intend to determine the effective dose for 90% of patients (ED90) of Carbetocin for achieving adequate uterine tone. The study population will consist of women with a body mass index (BMI) ≥ 40 kg/m2 undergoing elective cesarean section. The primary objective is to establish an optimal dose of Carbetocin in this specific high-risk demographic, building upon prior work that focused on women with lower BMIs. Specific doses, route, or sample size for this new study are not detailed in the abstract.

Results

This abstract primarily outlines the rationale for a new study, rather than presenting new findings from the study itself. However, it references a previous study conducted at Mount Sinai Hospital, which found that smaller doses of Carbetocin (14.8 mcg) were as effective in achieving adequate uterine tone at elective cesarean section compared to the current recommended dose of 100mcg. This prior research was specifically limited to women with a BMI < 40 kg/m2. The abstract highlights that maternal obesity has been shown to increase the risks of hemorrhage secondary to uterine atony, underscoring the need for the proposed dose-finding study in the BMI ≥ 40 kg/m2 population. No specific results or statistical data from the planned dose-finding study are presented in this abstract.

Key Findings

  • Previous study found 14.8 mcg Carbetocin as effective as 100 mcg for uterine tone in women with BMI < 40 kg/m2.
  • Maternal obesity (BMI ≥ 40 kg/m2) increases risk of postpartum hemorrhage due to uterine atony.

Why It Matters

Establishing the ED90 of Carbetocin for obese women undergoing C-sections is crucial for improving postpartum hemorrhage (PPH) prevention in a high-risk and growing patient population. Current dosing protocols may not be optimized for individuals with BMI ≥ 40 kg/m2, potentially leading to suboptimal outcomes or unnecessary higher doses. This research aims to provide an evidence-based Carbetocin protocol for this specific demographic, potentially refining the standard of care. A precise dose could reduce drug exposure, minimize potential side effects, and optimize resource utilization, moving towards more personalized and effective obstetric care. The findings will directly inform clinical practice regarding Carbetocin administration in obese patients.


carbetocin postpartum hemorrhage uterine atony cesarean section obesity dose-finding
Source: clinicaltrials:NCT03672045 · Ingested 2026-06-22 · Digest: gemini-2.5-flash