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Misoprostol+Oxytocin vs. Carbetocin in CS (CS)

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ClinicalTrials.gov Identifier: NCT02786992
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

Brief Summary:
This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: Misoprostol Drug: Oxytocin Drug: Carbetocin Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section
Study Start Date : May 2016
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Misoprostol + Oxytocin
400 ug sublingual misoprostol + 10 IU Oxytocin IVI
Drug: Misoprostol
Other Names:
  • Mesotec
  • Mesotac

Drug: Oxytocin
Other Name: Syntocinon

Drug: Placebo
Active Comparator: Carbetocin
100 ug Carbetocin IV
Drug: Carbetocin
Other Name: Pabal

Drug: Placebo



Primary Outcome Measures :
  1. incidence of post-partum hemorrhage [ Time Frame: 24 hours ]
  2. amount of blood loss [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Number of participants needing extra uterotonic drug (10 IU oxytocin IVI) [ Time Frame: 24 hours ]
    An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml.

  2. Number of participants needing hemostatic surgical interventions [ Time Frame: intra-operative ]
  3. Hemoglobin deficit in gm/dl [ Time Frame: 24 hours ]
    difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl

  4. APGAR score at 1 minute and 5 minutes [ Time Frame: 1 minute and 5 minutes ]
  5. Number of participants with NICU admission [ Time Frame: 24 hours ]
  6. Drug side effects [ Time Frame: 24 hours ]
  7. Time till resuming bowel habits [ Time Frame: 24 hours ]
    Time of passing gas will be recorded how many hours post-operative

  8. hematocrit deficit in % [ Time Frame: 24 hours ]
    difference between pre-operative and 24 hours post-operative hematocrit in %



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).

Exclusion Criteria:

  • hypersensitivity to oxytocin, carbetocin or prostaglandins
  • contraindication to prostaglandins (e.g. glaucoma)
  • history of significant heart disease
  • severe asthma
  • epilepsy
  • history or evidence of liver
  • renal or vascular disease
  • history of coagulopathy
  • thrombocytopenia or anticoagulant therapy
  • women with HELLP syndrome
  • eclampsia
  • women presenting by placental abruption
  • contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.

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): NCT02786992


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Mohamed S Sweed, MD, Dr, Ain Shams University
ClinicalTrials.gov Identifier: NCT02786992    
Other Study ID Numbers: AS1301
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Keywords provided by Mohamed S Sweed, MD, Ain Shams University:
Misoprostol
Oxytocin
Carbetocin
Prevention
Post-partum hemorrhage
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents