Surgical Management of Postpartum Haemorrhage Without Embolization

May 15, 2018 updated by: University Hospital, Montpellier

Surgical Management of Intractable Postpartum Haemorrhage When Arterial Embolization Can't be Performed : Feasibility an Complications.

Postpartum haemorrhage is the main cause of maternal mortality. The aim of investigators' study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine compression or hysterectomy) when the embolization of uterine arteries wasn't be performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

716

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with postpartum haemorrhage with a surgical management in a type III universitary maternity.

Description

Inclusion criteria:

  • Age over 18
  • Postpartum haemorrhage
  • Necessity of second line management
  • No embolization performed
  • Necessity of surgical management after embolization

Exclusion criteria:

  • Unnecessity of second line management
  • Management by only embolization
  • Incomplete medical files

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of each type of surgical management
Time Frame: at delivery
Frequency of each type of surgical management
at delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of surgical interventions
Time Frame: at delivery
Number of surgical interventions
at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Pierre BOULOT, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL17_0259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postpartum Hemorrhage

Clinical Trials on Arterial embolization and/or surgical management.

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