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: Completed
• Conditions: Fertility Disorders; Hemorrhage Postpartum

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of infertility	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		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.	type = infections , pelvic pain, cycle disorders	7 years
the frequency of obstetric complications for the next pregnancy		7 years
type of obstetrical complications	complications = intrauterine growth retardation, threat of premature labor	7 years
Frequency of recurrent postpartum haemorrhage in the next pregnancy		7 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Charles Garabedian, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): December 27, 2019
• Study Completion (Actual): December 27, 2019

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Fertility; Vaginal Birth; Hemorrhage Post-partum; Uterine balloon tamponade
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• 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: No
• Studies a U.S. FDA-regulated device product: No