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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

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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Carbetocin Drug: Oxytocin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
A single 100 microgram IV dose of carbetocin after operation
Drug: Oxytocin
Oxytocin with 30 international units (IU) IV infusion was used in this investigation
Other Name: Pitocin

Experimental: Carbetocin
A standard 30 international units (IU) IV infusion of oxytocin during two hours
Drug: Carbetocin
Carbetocin with single 100 microg IV dosage was used in this investigation
Other Names:
  • Duratocin,
  • Pabal,
  • Lonactene




Primary Outcome Measures :
  1. screening of Cessation of bleeding [ Time Frame: screening until 24 hours after placenta disconnection ]
  2. time duration to stop bleeding in the case of post-cesarean section [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02079558


Locations
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Iran, Islamic Republic of
Infertility and Reproductive Health Research Center
Tehran, Iran, Islamic Republic of, 1985717443
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: Robabeh Taheripanah, MD-Gyn. Infertility and Reproductive health Research center, Imam Hossien hospital, Shahid Beheshti Medical university, Tehran, Iran

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Robabeh Taheripanah, Associated prof. Obstetrics & Gynecology, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02079558     History of Changes
Other Study ID Numbers: IRHRC-021
JANU2014TAHERIPANAH
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014
Keywords provided by Dr Robabeh Taheripanah, Shahid Beheshti University of Medical Sciences:
prevention
cesarean section
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs