Septum; UterusNCT04449640
Uterine Rupture After Hysteroscopic Septum Resection
An observational study of Septum; Uterus and Rupture, Uterine, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
To date, several studies have already confirmed a positive effect of hysteroscopic metroplasty on reproductive outcomes in primary infertile women affected by uterine septum, the most common uterine malformation. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Septum; Uterus, Rupture, Uterine
- What is being tested?
- Hysteroscopic septum resection.
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2020to 1 Apr 2021
- 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 to 48 years
- Women only
- Adult
Study population: Pregnant women who underwent previous hysteroscopic septum resection.
Who may be able to join
- Previous hysteroscopic septum resection;
- Pregnancy;
- Uterine rupture.
Who cannot join
- Previous myomectomy (regardless of the surgical technique) or cesarean section.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Rupture in Pregnancy After Hysteroscopic Septum Resection: a Twenty-year Retrospective Analysis
To date, several studies have already confirmed a positive effect of hysteroscopic metroplasty on reproductive outcomes in primary infertile women affected by uterine septum, the most common uterine malformation. Nevertheless, very few data are available about the risk of uterine rupture in subsequent pregnancies after hysteroscopic septum resection (HSR). In order to shed about this element, we will retrospectively review the cases of uterine rupture in our setting in the last twenty years, identify which of them had previously undergone HSR, and evaluate the main clinical characteristics for each case.
- Conditions
- Septum; Uterus, Rupture, Uterine
- Being tested
- Hysteroscopic septum resection.
- Keywords
- Hysteroscopy, Uterine septum, Complications, Uterine perforation, Pregnancy, Uterine rupture
- Medical subject headings
- Uterine Rupture, Septate Uterus, Uterine Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic septum resection.Procedure or surgery
Resection of a uterine septum by hysteroscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Uterine rupture | Women who had uterine rupture during pregnancy. Receives: Procedure: Hysteroscopic septum resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine rupture
Rupture of muscular wall of the uterus tears during pregnancy or childbirth.
Measured: Retrospective analysis over the last twenty years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septum; UterusStudies of the same condition, open and under way.
- 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
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Università degli Studi di Brescia
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonio Simone Laganà, M.D., Ph.D., Study chair, Università degli Studi dell'InsubriaHelena Ban Frangež, M.D., Ph.D., Study director, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449640
- Sponsor's protocol ID
- URAHSR-1
- Status last verified
- Apr 2021
- First submitted
- 24 Jun 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Rupture in Pregnancy After Hysteroscopic Septum Resection: a Twenty-year Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04449640
- Acronym / sponsor ID
- URAHSR-1
- Conditions
- Septum; Uterus, Rupture, Uterine
- Keywords
- Hysteroscopy, Uterine septum, Complications, Uterine perforation, Pregnancy, Uterine rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Collaborators
- University of Ljubljana, Università degli Studi di Brescia
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 29 Jun 2020 (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.
To date, several studies have already confirmed a positive effect of hysteroscopic metroplasty on reproductive outcomes in primary infertile women affected by uterine septum, the most common uterine malformation. Nevertheless, very few data are available about the risk of uterine rupture in subsequent pregnancies after hysteroscopic septum resection (HSR). In order to shed about this element, we will retrospectively review the cases of uterine rupture in our setting in the last twenty years, identify which of them had previously undergone HSR, and evaluate the main clinical characteristics for each case.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterine rupture | – | Procedure: Hysteroscopic septum resection.Women who had uterine rupture during pregnancy. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women who underwent previous hysteroscopic septum resection.
Key inclusion criteria (3 listed)
- Previous hysteroscopic septum resection;
- Pregnancy;
- Uterine rupture.
Key exclusion criteria (1 listed)
- Previous myomectomy (regardless of the surgical technique) or cesarean section.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopic septum resection.Resection of a uterine septum by hysteroscopic surgery. | Procedure or surgery | Uterine rupture |
Primary outcome
Uterine rupture
Time frame: Retrospective analysis over the last twenty years.
Rupture of muscular wall of the uterus tears during pregnancy or childbirth.
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 29 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Simone Laganà, M.D., Ph.D. study chair
Università degli Studi dell'Insubria
Helena Ban Frangež, M.D., Ph.D. study director
University of Ljubljana
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 Septum; Uterus and Rupture, Uterine, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 3 inclusion and 1 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 29 Apr 2021. 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 Italy. 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?
Uterine rupture (time frame: Retrospective analysis over the last twenty 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 29 Apr 2021.