Overview

This trial is active, not recruiting.

Condition postpartum hemorrhage
Treatments carbetocin, oxytocin
Phase phase 4
Sponsor Ghamra Military Hospital
Collaborator Ain Shams Maternity Hospital
Start date February 2015
End date December 2016
Trial size 264 participants
Trial identifier NCT02391636, 1

Summary

Double blinded randomized controlled study

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose prevention
Arm
(Experimental)
100 μg intravenous injection at delivery of the anterior shoulder
carbetocin Pabal
at delivery of anterior shoulder
(Active Comparator)
5 IU intravenous injection at delivery of the anterior shoulder
oxytocin Syntocinon
at delivery of anterior shoulder

Primary Outcomes

Measure
amount of blood loss
time frame: 24 hours

Secondary Outcomes

Measure
need for another uterotonic medication
time frame: 5 minutes
need for blood transfusion or operative intervention
time frame: during surgery

Eligibility Criteria

Female participants from 20 years up to 40 years old.

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

Additional Information

Official title Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial
Principal investigator Maged M El.Sherif
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ghamra Military Hospital.