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Emergency Peripartum Hysterectomy: A Prospective Study in Iran

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ClinicalTrials.gov Identifier: NCT01285258
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : January 27, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine the effects of peripartum hysterectomy for maternal hemorrhage.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Procedure: hysterectomy Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Peripartum Hysterectomy for Maternal Hemorrhage
Study Start Date : March 2004
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
peripartum
patients whom underwent peripartum hysterectomy
Procedure: hysterectomy
excluding the uterus with saving ovaries


Outcome Measures

Primary Outcome Measures :
  1. death rate [ Time Frame: at 2 minutes after operation ]

Secondary Outcome Measures :
  1. urological complication [ Time Frame: at 2 minutes after operation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who have nonresponse hemorrhage after delivery

Exclusion Criteria:

  • Women who delivered before 24 weeks
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285258


Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: hamidreza shemshaki, MD MD,research comittee
More Information

Additional Information:
Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01285258     History of Changes
Other Study ID Numbers: ASD-1213-13
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: March 2004

Keywords provided by Isfahan University of Medical Sciences:
Peripartum
hysterectomy
placenta accreta
mortality

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage