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

Phase 4

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Carbetocin; Drug: Oxytocin

• Registration Number: NCT02391636
• Lead Sponsor: Ghamra Military Hospital

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-18
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbetocin arm	Carbetocin	100 μg intravenous injection at delivery of the anterior shoulder
oxytocin arm	Oxytocin	5 IU intravenous injection at delivery of the anterior shoulder

Primary Outcome Measures

Name	Time	Method
amount of blood loss	24 hours

Secondary Outcome Measures

Name	Time	Method
need for another uterotonic medication	5 minutes	after administration of Carbetocin or Oxytocin
need for blood transfusion or operative intervention	during surgery

Trial Locations

Locations (1)

Ghamra Military Hospital; 🇪🇬 Cairo, Egypt