Back to resultsIntrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery
Primary Purpose
Post Partum Hemorrhage
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Oxytocin
Sponsored by
About this trial
This is an interventional prevention trial for Post Partum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins.
3-Had no history of coagulopathy. 4-Accepting to participate in the study.
Exclusion Criteria:
\1-women with anemia (Haemoglobin <8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy
Sites / Locations
- Assiut Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
misoprostol
oxytocin
Arm Description
intrauterine 400 microgram
intravenous infusion 10 units
Outcomes
Primary Outcome Measures
amount of intraoperative blood loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03148574
Brief Title
Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery
Official Title
Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery to Reduce Intraoperative and Postoperative Blood Loss: A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 2, 2017 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
misoprostol
Arm Type
Experimental
Arm Description
intrauterine 400 microgram
Arm Title
oxytocin
Arm Type
Active Comparator
Arm Description
intravenous infusion 10 units
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
intrauterine tablets
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
intravenous
Primary Outcome Measure Information:
Title
amount of intraoperative blood loss
Time Frame
30 minutes
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins.
3-Had no history of coagulopathy. 4-Accepting to participate in the study.
Exclusion Criteria:
\1-women with anemia (Haemoglobin <8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy
Facility Information:
Facility Name
Assiut Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery
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