Fertility After Intrauterine Tamponing Balloon: Where Are we

Completed

• Conditions: Hemorrhage Postpartum; Fertility Disorders

• Registration Number: NCT04133402
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-21
• Study Start: 2019-11-19
• Primary Completion: 2019-12-27
• Study Completion: 2019-12-27
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of infertility	7 years	defined as the absence of pregnancy after 12 months of attempted pregnancy.

Secondary Outcome Measures

Name	Time	Method
Type of gynecological complications after use of an intrauterine tamponade balloon.	7 years	type = infections , pelvic pain, cycle disorders
type of obstetrical complications	7 years	complications = intrauterine growth retardation, threat of premature labor
the frequency of obstetric complications for the next pregnancy	7 years
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
Frequency of recurrent postpartum haemorrhage in the next pregnancy	7 years

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France