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NCT01285258 Clinical Trial

Emergency Peripartum Hysterectomy: A Prospective Study in Iran

Postpartum Hemorrhage Clinical Trial

Official title:
Study of Peripartum Hysterectomy for Maternal Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01285258
Other study ID # ASD-1213-13
Secondary ID
Status Completed
Phase Phase 2
First received January 26, 2011
Last updated January 26, 2011
Start date March 2004
Est. completion date March 2009

Study information
Verified date March 2004
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of peripartum hysterectomy for maternal hemorrhage.

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.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women who have nonresponse hemorrhage after delivery

Exclusion Criteria:

- Women who delivered before 24 weeks

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• hysterectomy
excluding the uterus with saving ovaries

Locations
Country Name City State
Iran, Islamic Republic of Al-zahra university hospital Isfahan

Sponsors (1)
Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary death rate at 2 minutes after operation Yes
Secondary urological complication at 2 minutes after operation Yes
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