Exploring cardiac effects after oxytocin 2.5 IU or carbetocin 100 μg: A randomised controlled trial in women undergoing planned caesarean delivery.

BACKGROUND

Oxytocin can stimulate release of myocardial biomarkers troponin I and T, prolong QTc and induce ST-depression.

OBJECTIVE

To explore cardiac changes after either intravenous carbetocin or oxytocin.

STUDY DESIGN

Exploratory phase 4 randomised controlled trial.

SETTING

Obstetrics units of Oslo University Hospital, Norway between September 2015 and May 2018.

PARTICIPANTS

Forty healthy, singleton pregnant women aged 18 to 50 years at gestational age at least 36 weeks with a planned caesarean delivery.

INTERVENTIONS

Participants were randomised to receive either oxytocin 2.5 IU or carbetocin 100 μg immediately after delivery.

MAIN OUTCOME MEASURES

The primary endpoint was the assessment of troponin I within 48 h of study drug administration. Troponin I and T, and creatine kinase myocardial band assessments were measured before spinal anaesthesia (baseline), and again at 4, 10 and 24 h after delivery. QTc, ST-depression and relative increase in heart rate were recorded from start of study drug administration to 10 min after delivery. All adverse events were monitored.

RESULTS

Compared with the carbetocin group, higher troponin I levels were observed in the oxytocin group at 4 h and 10 h after delivery. For both treatment groups, an increase from baseline in troponin I and T was most pronounced at 10 h after delivery, and it had begun to decline by 24 h. QTc increased with time after administration of both study drugs, with a mean maximum increase of 10.4 ms observed at 9 min (P   <  0.001). No statistical differences were observed in QTc ( P  = 0.13) or ST-depression ( P  = 0.11) between the treatment groups.

CONCLUSIONS

Oxytocin 2.5 IU and carbetocin 100 μg caused a similar increase in QTc. The trial was underpowered with regards to ST-depression and the release of myocardial biomarkers and these warrant further investigation. Data from this trial will inform a larger phase 4 trial to determine potential drug differences in troponin release.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02528136.