Fertility After Intrauterine Tamponing Balloon: Where Are we

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04133402

Acronym

FERTIBTIU

Enrollment

Registered

2019-10-21

Start date

2019-11-19

Completion date

2019-12-27

Last updated

2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility Disorders, Hemorrhage Postpartum

Keywords

Hemorrhage Post-partum, Fertility, Uterine balloon tamponade, Vaginal Birth

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of infertility	7 years	defined as the absence of pregnancy after 12 months of attempted pregnancy.

Secondary

Measure	Time frame	Description
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	type = infections , pelvic pain, cycle disorders
Time to obtain a new pregnancy evaluating the stop of contraceptionand desire for pregnancy	7 years	—
type of obstetrical complications	7 years	complications = intrauterine growth retardation, threat of premature labor
Frequency of recurrent postpartum haemorrhage in the next pregnancy	7 years	—
the frequency of obstetric complications for the next pregnancy	7 years	—

Countries

France

Outcome results