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NCT02079558 Clinical Trial

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

Postpartum Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02079558
Other study ID # IRHRC-021
Secondary ID JANU2014TAHERIPA
Status Completed
Phase Phase 2
First received January 13, 2014
Last updated March 4, 2014
Start date September 2012
Est. completion date September 2013

Study information
Verified date March 2014
Source Shahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Carbetocin
Carbetocin with single 100 microg IV dosage was used in this investigation
• Oxytocin
Oxytocin with 30 international units (IU) IV infusion was used in this investigation

Locations
Country Name City State
Iran, Islamic Republic of Infertility and Reproductive Health Research Center Tehran

Sponsors (1)
Lead Sponsor Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary screening of Cessation of bleeding screening until 24 hours after placenta disconnection
Primary time duration to stop bleeding in the case of post-cesarean section 24 hours
See also
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Terminated NCT01980173 - Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care N/A
Not yet recruiting NCT06033170 - Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage N/A
Completed NCT02163616 - Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study Phase 3
Not yet recruiting NCT02319707 - Management of the Third Stage of Labor Phase 3
Recruiting NCT01600612 - Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial N/A
Withdrawn NCT01108302 - Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India N/A
Completed NCT00097123 - RCT of Misoprostol for Postpartum Hemorrhage in India N/A
Completed NCT02883673 - Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage N/A
Completed NCT02542813 - Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers Phase 1
Completed NCT04201665 - EMG for Uterotonic Efficiency Estimation N/A
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Not yet recruiting NCT05501106 - Reducing Postpartum Hemorrhage After Vaginal Delivery N/A
Completed NCT05429580 - Prophylactic Tranexamic Acid Use After Vaginal Delivery N/A
Terminated NCT03064152 - Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery N/A
Recruiting NCT05382403 - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage N/A
Completed NCT03344302 - Oxytocin Administration During Cesarean Section Phase 4
Completed NCT02805426 - Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage Phase 4
Not yet recruiting NCT02853552 - Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding Phase 4
Completed NCT02910310 - Introduction of UBT for PPH Management in Three Countries N/A