- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04133402
Fertility After Intrauterine Tamponing Balloon: Where Are we (FERTIBTIU)
Evaluation of Fertility of Patients With a History of Postpartum Hemorrhage, Complicating Low-dose Delivery With Intrauterine Tamponade Treatment
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lille, France
- Hôpital Roger Salengro, CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of infertility
Time Frame: 7 years
|
defined as the absence of pregnancy after 12 months of attempted pregnancy.
|
7 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to obtain a new pregnancy evaluating the stop of contraceptionand desire for pregnancy
Time Frame: 7 years
|
7 years
|
|
Frequency of gynecological complications after use of an intrauterine tamponade balloon.
Time Frame: 7 years
|
7 years
|
|
Type of gynecological complications after use of an intrauterine tamponade balloon.
Time Frame: 7 years
|
type = infections , pelvic pain, cycle disorders
|
7 years
|
the frequency of obstetric complications for the next pregnancy
Time Frame: 7 years
|
7 years
|
|
type of obstetrical complications
Time Frame: 7 years
|
complications = intrauterine growth retardation, threat of premature labor
|
7 years
|
Frequency of recurrent postpartum haemorrhage in the next pregnancy
Time Frame: 7 years
|
7 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles Garabedian, MD,PhD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017_89
- 2018-A01609-46 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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