Hemorrhage PostpartumFERTIBTIUNCT04133402
Fertility After Intrauterine Tamponing Balloon: Where Are we
An observational study of Hemorrhage Postpartum and Fertility Disorders, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemorrhage Postpartum, Fertility Disorders
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2019to 27 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Vaginal birth
- Post partum haemorrhage
- Intrauterine tamponing balloon
- Between 2012 and 2017
- CHRU Lille and CH Valenciennes
Who cannot join
- Minor patients
- Initial intake started in another center (postpartum transfer).
- Refusal to participate in the study
- Invasive treatments for postpartum haemorrhage
- Caesarean
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemorrhage Postpartum, Fertility Disorders
- Keywords
- Hemorrhage Post-partum, Fertility, Uterine balloon tamponade, Vaginal Birth
- Medical subject headings
- Postpartum Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of infertility
defined as the absence of pregnancy after 12 months of attempted pregnancy.
Measured: 7 years
Secondary outcomes (6)
Time to obtain a new pregnancy evaluating the stop of contraceptionand desire for pregnancy
Measured: 7 years
Frequency of gynecological complications after use of an intrauterine tamponade balloon.
Measured: 7 years
Type of gynecological complications after use of an intrauterine tamponade balloon.
type = infections , pelvic pain, cycle disorders
Measured: 7 years
the frequency of obstetric complications for the next pregnancy
Measured: 7 years
type of obstetrical complications
complications = intrauterine growth retardation, threat of premature labor
Measured: 7 years
Frequency of recurrent postpartum haemorrhage in the next pregnancy
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start19 Nov 2019
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhage PostpartumStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Garabedian, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133402
- Sponsor's protocol ID
- 2017_89
- Other IDs
- 2018-A01609-46
- Acronym
- FERTIBTIU
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fertility of Patients With a History of Postpartum Hemorrhage, Complicating Low-dose Delivery With Intrauterine Tamponade Treatment
- ClinicalTrials.gov ID
- NCT04133402
- Acronym / sponsor ID
- FERTIBTIU / 2017_89
- Conditions
- Hemorrhage Postpartum, Fertility Disorders
- Keywords
- Hemorrhage Post-partum, Fertility, Uterine balloon tamponade, Vaginal Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Vaginal birth
- Post partum haemorrhage
- Intrauterine tamponing balloon
- Between 2012 and 2017
- CHRU Lille and CH Valenciennes
Key exclusion criteria (5 listed)
- Minor patients
- Initial intake started in another center (postpartum transfer).
- Refusal to participate in the study
- Invasive treatments for postpartum haemorrhage
- Caesarean
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of infertility
Time frame: 7 years
defined as the absence of pregnancy after 12 months of attempted pregnancy.
6 secondary outcomes
Time to obtain a new pregnancy evaluating the stop of contraceptionand desire for pregnancy
Time frame: 7 years
Frequency of gynecological complications after use of an intrauterine tamponade balloon.
Time frame: 7 years
Type of gynecological complications after use of an intrauterine tamponade balloon.
Time frame: 7 years
the frequency of obstetric complications for the next pregnancy
Time frame: 7 years
type of obstetrical complications
Time frame: 7 years
Frequency of recurrent postpartum haemorrhage in the next pregnancy
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Garabedian, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage Postpartum and Fertility Disorders, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of infertility (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.