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
2 other identifiers
observational
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedStudy Start
First participant enrolled
November 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2019
CompletedJuly 1, 2020
October 1, 2019
1 month
October 17, 2019
June 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of infertility
defined as the absence of pregnancy after 12 months of attempted pregnancy.
7 years
Secondary Outcomes (6)
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
Type of gynecological complications after use of an intrauterine tamponade balloon.
7 years
the frequency of obstetric complications for the next pregnancy
7 years
type of obstetrical complications
7 years
- +1 more secondary outcomes
Eligibility Criteria
Major patients with postpartum haemorrhage after vaginal delivery between 2012 and 2017 in Valenciennes maternity and the CHRU Lille, treated by intrauterine tamponade therapy.
You may qualify if:
- Vaginal birth
- Post partum haemorrhage
- Intrauterine tamponing balloon
- Between 2012 and 2017
- CHRU Lille and CH Valenciennes
You may not qualify if:
- Minor patients
- Initial intake started in another center (postpartum transfer).
- Refusal to participate in the study
- Invasive treatments for postpartum haemorrhage
- Caesarean
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Roger Salengro, CHU
Lille, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Garabedian, MD,PhD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2019
First Posted
October 21, 2019
Study Start
November 19, 2019
Primary Completion
December 27, 2019
Study Completion
December 27, 2019
Last Updated
July 1, 2020
Record last verified: 2019-10