Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean
Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries
1 other identifier
interventional
180
1 country
1
Brief Summary
The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedDecember 13, 2011
December 1, 2011
Same day
October 31, 2011
December 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraoperative bleeding
At the time of surgery
Secondary Outcomes (5)
Fever
During 48 hours after surgery measured every 3 hours
Changing of pulse rate from base
Before surgery & intraoperative & 6 hours after surgery
Changing of blood pressure
Before surgery & intraoperative & 6 hours after surgery
Diarrhea
Before & 6 hours after surgery
Vomiting
Before & 6 hours after surgery
Study Arms (1)
Misoprostol
EXPERIMENTALInterventions
Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia
Eligibility Criteria
You may qualify if:
- Indication of Cesarean Deliveries
- Elective or Emergency with Incision in Lower Segment in Women with
- Gestational Age more than 37 Weeks.
You may not qualify if:
- Anemia
- Multiple Pregnancy
- Polyhydraminus
- Prolonged Labor
- Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
- Hypertension
- Cardiovascular Disease
- Coagulopathy Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Soudabeh Eshghi alilead
- Kermanshah University of Medical Sciencescollaborator
Study Sites (1)
KUMS Obstetrics & Gynecology Department, Imam Reza Hospital
Kermanshah, Kermanshah Province, 67144-15333, Iran
Related Publications (1)
Eftekhari N, Doroodian M, Lashkarizadeh R. The effect of sublingual misoprostol versus intravenous oxytocin in reducing bleeding after caesarean section. J Obstet Gynaecol. 2009 Oct;29(7):633-6. doi: 10.1080/01443610903061744.
PMID: 19757270RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anisodowleh Nankali, MD
Kermanshah University of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Obstetrics & Gynecology Department
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 23, 2011
Study Start
August 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
December 13, 2011
Record last verified: 2011-12