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

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ClinicalTrials.gov Identifier: NCT02391636
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : January 25, 2017
Sponsor:
Collaborator:
Ain Shams Maternity Hospital
Information provided by (Responsible Party):
Maged El.Sherif, Ghamra Military Hospital

Brief Summary:
Double blinded randomized controlled study

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Carbetocin Drug: Oxytocin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Comparison Between Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage: A Randomized Controlled Trial
Study Start Date : February 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Carbetocin arm
100 μg intravenous injection at delivery of the anterior shoulder
Drug: Carbetocin
at delivery of anterior shoulder
Other Name: Pabal

Active Comparator: oxytocin arm
5 IU intravenous injection at delivery of the anterior shoulder
Drug: Oxytocin
at delivery of anterior shoulder
Other Name: Syntocinon




Primary Outcome Measures :
  1. amount of blood loss [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. need for another uterotonic medication [ Time Frame: 5 minutes ]
    after administration of Carbetocin or Oxytocin

  2. need for blood transfusion or operative intervention [ Time Frame: during surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391636


Locations
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Egypt
Ghamra Military Hospital
Cairo, Egypt
Sponsors and Collaborators
Ghamra Military Hospital
Ain Shams Maternity Hospital
Investigators
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Principal Investigator: Maged M El.Sherif Ghamra Military Hospital

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Responsible Party: Maged El.Sherif, Registrar of OB/GYN, Ghamra Military Hospital
ClinicalTrials.gov Identifier: NCT02391636     History of Changes
Other Study ID Numbers: 1
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by Maged El.Sherif, Ghamra Military Hospital:
Postpartum Hemorrhage
carbetocin
oxytocin

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs