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Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section

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ClinicalTrials.gov Identifier: NCT02079558
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Robabeh Taheripanah, Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 13, 2014
First Posted Date  ICMJE March 6, 2014
Last Update Posted Date March 6, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • screening of Cessation of bleeding [ Time Frame: screening until 24 hours after placenta disconnection ]
  • time duration to stop bleeding in the case of post-cesarean section [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
Official Title  ICMJE Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
Brief Summary Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality. The prompt and effective treatment of subjects with PPH would reduce operation risks. Hence in this study, the efficacy of Oxytocin and Carbetocin was compared in prevention of postpartum hemorrhage after cesarean sections.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Condition  ICMJE Postpartum Hemorrhage
Intervention  ICMJE
  • Drug: Carbetocin
    Carbetocin with single 100 microg IV dosage was used in this investigation
    Other Names:
    • Duratocin,
    • Pabal,
    • Lonactene
  • Drug: Oxytocin
    Oxytocin with 30 international units (IU) IV infusion was used in this investigation
    Other Name: Pitocin
Study Arms  ICMJE
  • Experimental: Oxytocin
    A single 100 microgram IV dose of carbetocin after operation
    Intervention: Drug: Oxytocin
  • Experimental: Carbetocin
    A standard 30 international units (IU) IV infusion of oxytocin during two hours
    Intervention: Drug: Carbetocin
Publications * Taheripanah R, Shoman A, Karimzadeh MA, Zamaniyan M, Malih N. Efficacy of oxytocin versus carbetocin in prevention of postpartum hemorrhage after cesarean section under general anesthesia: a prospective randomized clinical trial. J Matern Fetal Neonatal Med. 2018 Nov;31(21):2807-2812. doi: 10.1080/14767058.2017.1355907. Epub 2017 Jul 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2014)
220
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin

Exclusion Criteria:

  • Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02079558
Other Study ID Numbers  ICMJE IRHRC-021
JANU2014TAHERIPANAH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Robabeh Taheripanah, Shahid Beheshti University of Medical Sciences
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robabeh Taheripanah, MD-Gyn. Infertility and Reproductive health Research center, Imam Hossien hospital, Shahid Beheshti Medical university, Tehran, Iran
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP