A study on carbetocin (Pabal®) versus oxytocin (Syntocinon®)

Study on the use of carbetocin (Pabal®) in comparison with oxytocin (Syntocinon®) for the prevention of postpartum haemorrhage (the need for additional uterotonic medication) after elective caesarean section

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN98070045

Enrollment

1500

Registered

2012-03-07

Start date

2009-07-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Obstetrics / Caesarean section Pregnancy and Childbirth

Interventions

After treatment on prescription with carbetocin or oxytocin, information will be gathered from the patient's chart. The follow-up time is 24 hours after medication administration.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Charts of women who have undergone elective CS under epidural and/or spinal anaesthesia and treated with carbetocin or oxytocin.

Exclusion criteria

Exclusion criteria: Contraindications, warnings, precautions and interactions with other drugs mentioned in the summary of product characteristics of carbetocin and oxytocin.

Design outcomes

Primary

Measure	Time frame
Need for additional uterotonic treatment during the first 24 hours after carbetocin or oxytocin administration.	—

Secondary

Measure	Time frame
1. Need for blood transfusion during the first 24 hours 2. Need for operative interventions other than the initial CS during the first 24 hours 3. Need for uterus massage during the first 24 hours 4. Change in haematocrit and haemoglobin post versus pre CS 5. Amount of intraoperative blood loss 6. Incidence of intraoperative blood loss > 500 ml 7. Incidence of intraoperative blood loss > 1000 ml 8. Position of fundus after wound closure (only in prospective part of the study) 9. Uterus tone after uterotonic treatment 10. Investigator?s subjective experience with oxytocin/carbetocin	—

Measure

Time frame

1. Need for blood transfusion during the first 24 hours 2. Need for operative interventions other than the initial CS during the first 24 hours 3. Need for uterus massage during the first 24 hours 4. Change in haematocrit and haemoglobin post versus pre CS 5. Amount of intraoperative blood loss 6. Incidence of intraoperative blood loss > 500 ml 7. Incidence of intraoperative blood loss > 1000 ml 8. Position of fundus after wound closure (only in prospective part of the study) 9. Uterus tone after uterotonic treatment 10. Investigator?s subjective experience with oxytocin/carbetocin

—

Countries

Netherlands

Outcome results

None listed

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