Fertility After Intrauterine Tamponing Balloon: Where Are we | NCT04133402

Studies
Fertility After Intrauterine Tamponing Balloon: Where Are we

NCT04133402

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Jul 1, 2020Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Hemorrhage Postpartum
Fertility Disorders

Interventions

Not provided

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

ID	Type	Description	Link
2018-A01609-46	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Oct 2019

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

Nov 19, 2019Actual

Primary Completion Date

Dec 27, 2019Actual

Completion Date

Dec 27, 2019Actual

First Submitted Date

Oct 17, 2019

First Submission Date that Met QC Criteria

Oct 18, 2019

First Posted Date

Oct 21, 2019Actual

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

Jun 29, 2020

Last Update Posted Date

Jul 1, 2020Actual

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

Today, few data are available on the patient's fertility following intrauterine tamponade balloon (BTIU) used for postpartum hemorrhage (PPH) after vaginal delivery (AVB). Several studies have concluded that there are no fertility disorders after conservative surgical treatment or embolization. BTIU is an essential treatment in the management of PPH. The aim was to evaluate post-BTIU fertility and the appearance of gynecological symptoms.

This is a bicentric retrospective study (Valenciennes, Lille, France), between 2012 and 2017. The data will be collected by telephone interview on fertility and various gynecological functional symptoms.

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

59Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of infertility	defined as the absence of pregnancy after 12 months of attempted pregnancy.	7 years

Secondary Outcomes

Measure	Description	Time Frame
Time to obtain a new pregnancy evaluating the stop of contraceptionand desire for pregnancy		7 years
Frequency of gynecological complications after use of an intrauterine tamponade balloon.		7 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Vaginal birth
Post partum haemorrhage
Intrauterine tamponing balloon
Between 2012 and 2017
CHRU Lille and CH Valenciennes

Exclusion Criteria:

Minor patients
Initial intake started in another center (postpartum transfer).
Refusal to participate in the study
Invasive treatments for postpartum haemorrhage
Caesarean

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Major patients with postpartum haemorrhage after vaginal delivery between 2012 and 2017 in Valenciennes maternity and the CHRU Lille, treated by intrauterine tamponade therapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Garabedian, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Roger Salengro, CHU		Lille			France

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