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Purpose <p>Class III obesity (body mass index [BMI] ≥ 40&#xa0;kg·m<sup>−2</sup>) 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&#xa0;µg <i>iv</i> compared with oxytocin 1&#xa0;IU <i>iv</i> (plus infusion) at elective Cesarean delivery in parturients with class III obesity. We hypothesized that, with equipotent dosing, carbetocin would be noninferior to oxytocin.</p> Methods <p>We conducted a randomized, double-blind, noninferiority study in nonlabouring, term parturients with BMI ≥ 40&#xa0;kg·m<sup>−2</sup> undergoing elective Cesarean delivery under neuraxial anesthesia. Patients received either a 1-IU bolus of oxytocin <i>iv</i> followed by an infusion of 4.8&#xa0;IU·hr<sup>−1</sup> or an 80-µg carbetocin bolus <i>iv</i> followed by a placebo infusion. Uterine tone was determined by palpation by the obstetrician at 3, 5, and 10&#xa0;min, using a verbal numerical rating score of 0 (boggy) to 10 (firm). The primary outcome was uterine tone at 3&#xa0;min. Secondary outcomes included uterine tone at 5 and 10&#xa0;min, blood loss, additional uterotonics, and side effects.</p> Results <p>Forty-seven participants were included in the analysis. Median tone at 3&#xa0;min was similar for oxytocin (8; 95% confidence interval [CI], 7 to 8) and carbetocin (8; 95% CI, 8 to 9) (<i>P</i> = 0.06), with no difference at 5 and 10&#xa0;min. Blood loss, side effects, and the need for additional uterotonics were not significantly different between the study groups.</p> Conclusion <p>We conclude that carbetocin is noninferior to oxytocin at elective Cesarean delivery in parturients with class III obesity, with the advantage of single bolus dosing without infusion.</p> Study registration <p>ClinicalTrials.gov (<ExternalRef> <RefSource>NCT04902729</RefSource> <RefTarget Address="NCT04902729" TargetType="Other" /> </ExternalRef>); first submitted 21 May 2021.</p>

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Oxytocin versus carbetocin at elective Cesarean delivery in parturients with class III obesity: a double-blind randomized controlled noninferiority trial

  • 期刊论文

  • 发表日期：

    2025年1月6日

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  • William Turner,
  • Linda Boonstra,
  • Cynthia Maxwell,
  • Kristy Downey,
  • Mrinalini Balki

摘要

Purpose

Class III obesity (body mass index [BMI] ≥ 40 kg·m−2) 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.

Methods

We conducted a randomized, double-blind, noninferiority study in nonlabouring, term parturients with BMI ≥ 40 kg·m−2 undergoing elective Cesarean delivery under neuraxial anesthesia. Patients received either a 1-IU bolus of oxytocin iv followed by an infusion of 4.8 IU·hr−1 or an 80-µg carbetocin bolus iv followed by a placebo infusion. Uterine tone was determined by palpation by the obstetrician at 3, 5, and 10 min, using a verbal numerical rating score of 0 (boggy) to 10 (firm). The primary outcome was uterine tone at 3 min. Secondary outcomes included uterine tone at 5 and 10 min, blood loss, additional uterotonics, and side effects.

Results

Forty-seven participants were included in the analysis. Median tone at 3 min was similar for oxytocin (8; 95% confidence interval [CI], 7 to 8) and carbetocin (8; 95% CI, 8 to 9) (P = 0.06), with no difference at 5 and 10 min. Blood loss, side effects, and the need for additional uterotonics were not significantly different between the study groups.

Conclusion

We conclude that carbetocin is noninferior to oxytocin at elective Cesarean delivery in parturients with class III obesity, with the advantage of single bolus dosing without infusion.

Study registration

ClinicalTrials.gov ( NCT04902729 ); first submitted 21 May 2021.