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Completed

NCT Number: NCT04133402

Fertility After Intrauterine Tamponing Balloon: Where Are we

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.

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Key information

Conditions

Hemorrhage Postpartum Female Urogenital Diseases and Pregnancy Complications Fertility Disorders Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Roger Salengro, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of infertility

    Time frame: 7 years

    defined as the absence of pregnancy after 12 months of attempted pregnancy.

Secondary outcomes

  1. Time to obtain a new pregnancy evaluating the stop of contraceptionand desire for pregnancy

    Time frame: 7 years

  2. Frequency of gynecological complications after use of an intrauterine tamponade balloon.

    Time frame: 7 years

  3. Type of gynecological complications after use of an intrauterine tamponade balloon.

    Time frame: 7 years

    type = infections , pelvic pain, cycle disorders

  4. the frequency of obstetric complications for the next pregnancy

    Time frame: 7 years

  5. type of obstetrical complications

    Time frame: 7 years

    complications = intrauterine growth retardation, threat of premature labor

  6. Frequency of recurrent postpartum haemorrhage in the next pregnancy

    Time frame: 7 years

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: FERTIBTIU

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2019
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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