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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391636
• Other study ID #: 1
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2015
• Last updated: January 24, 2017
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Ghamra Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Double blinded randomized controlled study

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Carbetocin
at delivery of anterior shoulder
• Oxytocin
at delivery of anterior shoulder

Locations

Country	Name	City	State
Egypt	Ghamra Military Hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ghamra Military Hospital	Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of blood loss		24 hours
Secondary	need for another uterotonic medication	after administration of Carbetocin or Oxytocin	5 minutes
Secondary	need for blood transfusion or operative intervention		during surgery