Emergency Peripartum Hysterectomy: A Prospective Study in Iran
This study has been completed.
Sponsor:
Isfahan University of Medical Sciences
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01285258
First received: January 26, 2011
Last updated: NA
Last verified: March 2004
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 26, 2011 | ||||
| Last Updated Date | January 26, 2011 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
death rate [ Time Frame: at 2 minutes after operation ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
urological complication [ Time Frame: at 2 minutes after operation ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Emergency Peripartum Hysterectomy: A Prospective Study in Iran | ||||
| Official Title ICMJE | Study of Peripartum Hysterectomy for Maternal Hemorrhage | ||||
| Brief Summary | The purpose of this study is to determine the effects of peripartum hysterectomy for maternal hemorrhage. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Postpartum Hemorrhage | ||||
| Intervention ICMJE | Procedure: hysterectomy
excluding the uterus with saving ovaries |
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| Study Arm (s) | peripartum
patients whom underwent peripartum hysterectomy
Intervention: Procedure: hysterectomy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 41 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01285258 | ||||
| Other Study ID Numbers ICMJE | ASD-1213-13 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences | ||||
| Study Sponsor ICMJE | Isfahan University of Medical Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Isfahan University of Medical Sciences | ||||
| Verification Date | March 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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