Clinical trial NCT02391636: Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage
Official title: Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Hemorrhage
Keywords: Postpartum Hemorrhage
carbetocin
oxytocin
Lead sponsor: Ghamra Military Hospital
Sponsor class: OTHER
Collaborators: name: Ain Shams Maternity Hospital
First posted: 2015-03-18
Enrollment: 264
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: amount of blood loss
timeFrame: 24 hours
Secondary outcomes:
measure: need for another uterotonic medication
timeFrame: 5 minutes
measure: need for blood transfusion or operative intervention
timeFrame: during surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ghamra Military Hospital
Study officials:
affiliation: Ghamra Military Hospital
name: Maged M El.Sherif
role: PRINCIPAL_INVESTIGATOR
References: