Fertility After Intrauterine Tamponing Balloon: Where Are we

NCT ID: NCT04133402

Last Updated: 2020-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-19

Study Completion Date

2019-12-27

Brief Summary

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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

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Conditions

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Hemorrhage Postpartum Fertility Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Garabedian, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, CHU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2018-A01609-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017_89

Identifier Type: -

Identifier Source: org_study_id

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