Back to resultsComparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean
Primary Purpose
Bleeding Intraoperative
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
About this trial
This is an interventional prevention trial for Bleeding Intraoperative focused on measuring Misoprostol, Oxytocin, Cesarean Delivery, Blood Loss
Eligibility Criteria
Inclusion Criteria:
- Indication of Cesarean Deliveries
- Elective or Emergency with Incision in Lower Segment in Women with
- Gestational Age more than 37 Weeks.
Exclusion Criteria:
- Anemia
- Multiple Pregnancy
- Polyhydraminus
- Prolonged Labor
- Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
- Hypertension
- Cardiovascular Disease
- Coagulopathy Disease
Sites / Locations
- KUMS Obstetrics & Gynecology Department, Imam Reza Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Misoprostol
Arm Description
Outcomes
Primary Outcome Measures
Intraoperative bleeding
Secondary Outcome Measures
Fever
Changing of pulse rate from base
Changing of blood pressure
Diarrhea
Vomiting
Full Information
NCT ID
NCT01477840
First Posted
October 31, 2011
Last Updated
December 12, 2011
Sponsor
Soudabeh Eshghi ali
Collaborators
Kermanshah University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01477840
Brief Title
Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean
Official Title
Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Soudabeh Eshghi ali
Collaborators
Kermanshah University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Intraoperative
Keywords
Misoprostol, Oxytocin, Cesarean Delivery, Blood Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Misoprostol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Brand Name: Cytotec, Cyotec, Serial 022-00 , Code A02BB01
Intervention Description
Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia
Primary Outcome Measure Information:
Title
Intraoperative bleeding
Time Frame
At the time of surgery
Secondary Outcome Measure Information:
Title
Fever
Time Frame
During 48 hours after surgery measured every 3 hours
Title
Changing of pulse rate from base
Time Frame
Before surgery & intraoperative & 6 hours after surgery
Title
Changing of blood pressure
Time Frame
Before surgery & intraoperative & 6 hours after surgery
Title
Diarrhea
Time Frame
Before & 6 hours after surgery
Title
Vomiting
Time Frame
Before & 6 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Indication of Cesarean Deliveries
Elective or Emergency with Incision in Lower Segment in Women with
Gestational Age more than 37 Weeks.
Exclusion Criteria:
Anemia
Multiple Pregnancy
Polyhydraminus
Prolonged Labor
Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
Hypertension
Cardiovascular Disease
Coagulopathy Disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anisodowleh Nankali, MD
Phone
98 831 4276310
Email
anankali@kums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anisodowleh Nankali, MD
Organizational Affiliation
Kermanshah University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
KUMS Obstetrics & Gynecology Department, Imam Reza Hospital
City
Kermanshah
ZIP/Postal Code
67144-15333
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anisodowleh Nankali, MD
Phone
98 831 4276310
Email
anankali@kums.ac.ir
First Name & Middle Initial & Last Name & Degree
Soudabeh Eshghi Ali, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19757270
Citation
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.
Results Reference
result
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Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean
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