Surgical Management of Postpartum Haemorrhage Without Emb... | NCT03517800

Studies
Surgical Management of Postpartum Haemorrhage Without Embolization

NCT03517800

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

May 18, 2018Actual

Enrollment

716Actual

Phase

Not provided

Conditions

Postpartum Hemorrhage
Second Line Management
Uterine Arteries Embolization
Surgical Management of Haemorrhage

Interventions

Arterial embolization and/or surgical management.

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 1, 2015Actual

Completion Date

Oct 1, 2016Actual

First Submitted Date

Oct 12, 2017

First Submission Date that Met QC Criteria

Apr 24, 2018

First Posted Date

May 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2018

Last Update Posted Date

May 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

716Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arterial embolization and/or surgical management.	Other	Arterial embolization and/or surgical management.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre BOULOT	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided