Skip to content

Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage

Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02391636
Enrollment
264
Registered
2015-03-18
Start date
2015-02-28
Completion date
2016-12-31
Last updated
2017-01-25

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

Conditions

Postpartum Hemorrhage

Keywords

Postpartum Hemorrhage, carbetocin, oxytocin

Brief summary

Double blinded randomized controlled study

Detailed description

Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST. 264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used. Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous injection at delivery of the anterior shoulder. Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous injection at delivery of the anterior shoulder. * All patients will receive general anaesthesia. * Operation will be carried out by a three year registrar (at least). * Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss. * Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood loss will be calculated using the following equation: * The actual blood loss equals the estimated blood volume X difference between the initial hematocrit and the final hematocrit / the initial hematocrit Secondary endpoints include: 1. The need for additional uterotonic medication after carbetocin or oxytocin administration. \- Uterine tone and Uterine fundus level (with respect to the umbilical point, UP) will be monitored during CS, at the end of CS, 2 hours, 12 hours and 24 hours after delivery \- Additional uterotonic drugs, needed if sufficient uterine tone is not achieved within 5 minutes of oxytocin or carbetocin administration, will include: i. Ergometrine 0.5 mg by slow intravenous injection. ii. Misopristol 1000 micrograms rectally. 2. The need for blood transfusion or operative interventions related to PPH \- The need for blood transfusion or operative intervention (B-Lynch sutures, uterine artery ligation, internal iliac artery ligation, Hysterectomy) will be considered. 3. The change in hemoglobin and hematocrit post versus pre CS \- The drop in hemoglobin level and hematocrit will be evaluated by comparing the hemoglobin concentration on admission and 24 hours after delivery. 4. The hemodynamic adverse effects and the cost-benefit of both drugs.

Interventions

DRUGCarbetocin

at delivery of anterior shoulder

DRUGOxytocin

at delivery of anterior shoulder

Sponsors

Ain Shams Maternity Hospital
CollaboratorOTHER
Ghamra Military Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Multiple pregnancy * Presence of uterine fibroid * Previous Myomectomy * Presence of placenta previa * Past History of PPH * Fetal Macrosomia * Polyhydramnios

Exclusion criteria

* Hypertension * Preeclampsia * Cardiac, Renal, Liver diseases * Epilepsy * History of hypersensitivity to Carbetocin

Design outcomes

Primary

MeasureTime frame
amount of blood loss24 hours

Secondary

MeasureTime frameDescription
need for another uterotonic medication5 minutesafter administration of Carbetocin or Oxytocin
need for blood transfusion or operative interventionduring surgery

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026