Back to resultsEmergency Peripartum Hysterectomy: A Prospective Study in Iran
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Peripartum, hysterectomy, placenta accreta, mortality
Eligibility Criteria
Inclusion Criteria:
- Women who have nonresponse hemorrhage after delivery
Exclusion Criteria:
- Women who delivered before 24 weeks
Sites / Locations
- Al-zahra university hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
peripartum
Arm Description
patients whom underwent peripartum hysterectomy
Outcomes
Primary Outcome Measures
death rate
Secondary Outcome Measures
urological complication
Full Information
NCT ID
NCT01285258
First Posted
January 26, 2011
Last Updated
January 26, 2011
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01285258
Brief Title
Emergency Peripartum Hysterectomy: A Prospective Study in Iran
Official Title
Study of Peripartum Hysterectomy for Maternal Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
March 2004
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of peripartum hysterectomy for maternal hemorrhage.
Detailed Description
Emergency peripartum hysterectomy is a life-saving surgical procedure which performed to control massive hemorrhage. This study was conducted to determine the factors leading to and maternal mortality and morbidity rates among the women whose underwent peripartum hysterectomy with the focus on referral or non-referral patient status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Peripartum, hysterectomy, placenta accreta, mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
peripartum
Arm Type
Other
Arm Description
patients whom underwent peripartum hysterectomy
Intervention Type
Procedure
Intervention Name(s)
hysterectomy
Intervention Description
excluding the uterus with saving ovaries
Primary Outcome Measure Information:
Title
death rate
Time Frame
at 2 minutes after operation
Secondary Outcome Measure Information:
Title
urological complication
Time Frame
at 2 minutes after operation
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women who have nonresponse hemorrhage after delivery
Exclusion Criteria:
Women who delivered before 24 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamidreza shemshaki, MD
Organizational Affiliation
MD,research comittee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.mui.ac.ir
Description
Isfahan university of medical sciences
Learn more about this trial
Emergency Peripartum Hysterectomy: A Prospective Study in Iran
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