Randomised trial of carbetocin versus oxytocin for the prevention of postpartum haemorrhage after caesarean section - LOXY Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002812-94-GB

Enrollment

380

Registered

2005-06-29

Start date

2005-09-09

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum haemorrhage after caesarean section

Interventions

Trade Name: Lonactene Product Name: Carbetocin Pharmaceutical Form: Solution for injection Trade Name: Syntocinon Product Name: Oxytoci

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women undergoing elective or emergency caesarean section after 37 weeks of pregnancy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women with multiple gestation, placenta praevia and placental abruption. Women undergoing caesarean section with general anaesthesia. Women with caesarean section at less than 37 weeks. Women having emergency caesarean section for fetal or maternal distress.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether carbetocin results in fewer medical measures to stop bleeding after caesarean section than oxytocin.; Secondary Objective: To evaluate: Whether carbetocin has a similar side effect profile to oxytocin. Whether carbetocin results in smaller blood loss during caesarean section than oxytocin. Whether carbetocin results in shorter duration of stay in the delivery ward. ;Primary end point(s): The proportion of patients who will need additional oxytocic measures/medications in the 48 hours following the administration of the study drug (carbetocin or oxytocin).	—

Measure

Time frame

Main Objective: To evaluate whether carbetocin results in fewer medical measures to stop bleeding after caesarean section than oxytocin.; Secondary Objective: To evaluate: Whether carbetocin has a similar side effect profile to oxytocin. Whether carbetocin results in smaller blood loss during caesarean section than oxytocin. Whether carbetocin results in shorter duration of stay in the delivery ward. ;Primary end point(s): The proportion of patients who will need additional oxytocic measures/medications in the 48 hours following the administration of the study drug (carbetocin or oxytocin).

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026