Fertility After Intrauterine Tamponing Balloon: Where Are we

Fertility Disorders Clinical Trial

— FERTIBTIU  

Official title:

Evaluation of Fertility of Patients With a History of Postpartum Hemorrhage, Complicating Low-dose Delivery With Intrauterine Tamponade Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133402
• Other study ID #: 2017_89
• Secondary ID: 2018-A01609-46
• Status: Completed
• Start date: November 19, 2019
• Est. completion date: December 27, 2019

Study information

• Verified date: October 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 27, 2019
• Est. primary completion date: December 27, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders
• Hemorrhage
• Hemorrhage Postpartum
• Postpartum Hemorrhage

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of infertility	defined as the absence of pregnancy after 12 months of attempted pregnancy.	7 years
Secondary	Time to obtain a new pregnancy evaluating the stop of contraceptionand desire for pregnancy		7 years
Secondary	Frequency of gynecological complications after use of an intrauterine tamponade balloon.		7 years
Secondary	Type of gynecological complications after use of an intrauterine tamponade balloon.	type = infections , pelvic pain, cycle disorders	7 years
Secondary	the frequency of obstetric complications for the next pregnancy		7 years
Secondary	type of obstetrical complications	complications = intrauterine growth retardation, threat of premature labor	7 years
Secondary	Frequency of recurrent postpartum haemorrhage in the next pregnancy		7 years