NCT01285258

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
Last Updated

January 27, 2011

Status Verified

March 1, 2004

Enrollment Period

5 years

First QC Date

January 26, 2011

Last Update Submit

January 26, 2011

Conditions

Postpartum Hemorrhage

Keywords

Peripartumhysterectomyplacenta accretamortality

Outcome Measures

Primary Outcomes (1)

  • death rate

    at 2 minutes after operation

Secondary Outcomes (1)

  • urological complication

    at 2 minutes after operation

Study Arms (1)

peripartum

OTHER

patients whom underwent peripartum hysterectomy

Procedure: hysterectomy

Interventions

hysterectomyPROCEDURE

excluding the uterus with saving ovaries

peripartum

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women who have nonresponse hemorrhage after delivery

You may not qualify if:

  • Women who delivered before 24 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Postpartum HemorrhagePlacenta Accreta

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPlacenta Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • hamidreza shemshaki, MD

    MD,research comittee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

March 1, 2004

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 27, 2011

Record last verified: 2004-03

Locations

IR(1)