Uterine FibroidLPTM-UFs-PNCT06009562
Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study
An observational study of Uterine Fibroid and Pregnancy Related, run by University of Palermo at 1 site in Russia.
Trial summary
The frequency of women presenting with a combination of uterine fibroids and pregnancy is in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of different lev-els of severity. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Fibroid, Pregnancy Related
- What is being tested?
- Laparotomic myomectomy during pregnancy
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteRussia
- Study dates
- 19 Aug 2023to 1 Jan 2024
- How long will I take part?
- 5 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnant women with symptomatic uterine fibroids (UFs)
Who may be able to join
- The large and giant size of UFs, which prevent the proper continuation of pregnancy and/or occupy the entire small and large pelvis, as well as invade and/or occupy the abdominal cavity.
- Circulatory disorders, evidenced by necrosis of the UFs.
- Atypical localization of UFs (cervical, isthmic, intraligamentary, etc.), which caused pelvic organ dysfunction (dysuric phenomena, tenesmus, impediment to the act of defecation, pelvic pain).
Who cannot join
- Refusal of LPTM by the patient.
- Absence of urgent indication for LPTM during pregnancy.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State-Funded Health Care Facility of Moscow Region (GBUZ MO MONIIAG)
Moscow, 101000
Andrea Etrusco, M.D., +39 388 1614022, etruscoandrea@gmail.com
About this study
The frequency of women presenting with a combination of uterine fibroids and pregnancy is in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the problem of clarifying the management tactics of pregnant patients with symptomatic fibroids, who may see their preg-nancy put at risk by these masses.
- Conditions
- Uterine Fibroid, Pregnancy Related
- Being tested
- Laparotomic myomectomy during pregnancy
- Keywords
- Uterine fibroids, Pregnancy, myomectomy, fetal outcomes
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparotomic myomectomy during pregnancyProcedure or surgery
Surgical removal of symptomatic uterine fibroids in pregnancy by laparotomic access
What is being measured
The primary outcome is the main question the study is designed to answer.
continuation of pregnancy
Pregnancy continuation after surgery.
Measured: 5 months
Secondary outcomes (1)
Fetal outcome
Assessed by APGAR 1 and 5 min, birth weight, and fetal conformation.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start19 Aug 2023 (estimated)
- Primary completion19 Aug 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies 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
- Prospective
- Enrolment
- 28 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Etrusco, University of Palermo
- Investigators
- Andrea Etrusco, M.D., Principal investigator, University of PalermoAntonio Simone Laganà, M.D. Ph.D., Study director, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009562
- Sponsor's protocol ID
- LPTM-S-UFs-Pregancy
- Acronym
- LPTM-UFs-P
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06009562
- Acronym / sponsor ID
- LPTM-UFs-P / LPTM-S-UFs-Pregancy
- Conditions
- Uterine Fibroid, Pregnancy Related
- Keywords
- Uterine fibroids, Pregnancy, myomectomy, fetal outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 19 Aug 2023 (estimated)
- Primary completion
- 19 Aug 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 24 Aug 2023 (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.
The frequency of women presenting with a combination of uterine fibroids and pregnancy is in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the problem of clarifying the management tactics of pregnant patients with symptomatic fibroids, who may see their preg-nancy put at risk by these masses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Months
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women with symptomatic uterine fibroids (UFs)
Key inclusion criteria (3 listed)
- The large and giant size of UFs, which prevent the proper continuation of pregnancy and/or occupy the entire small and large pelvis, as well as invade and/or occupy the abdominal cavity.
- Circulatory disorders, evidenced by necrosis of the UFs.
- Atypical localization of UFs (cervical, isthmic, intraligamentary, etc.), which caused pelvic organ dysfunction (dysuric phenomena, tenesmus, impediment to the act of defecation, pelvic pain).
Key exclusion criteria (2 listed)
- Refusal of LPTM by the patient.
- Absence of urgent indication for LPTM during pregnancy.
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 |
|---|---|---|
| Laparotomic myomectomy during pregnancySurgical removal of symptomatic uterine fibroids in pregnancy by laparotomic access | Procedure or surgery | – |
Primary outcome
continuation of pregnancy
Time frame: 5 months
Pregnancy continuation after surgery.
1 secondary outcome
Fetal outcome
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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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.
Andrea Etrusco, M.D. principal investigator
University of Palermo
Antonio Simone Laganà, M.D. Ph.D. study director
University of Palermo
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 Uterine Fibroid and Pregnancy Related, run by University of Palermo at 1 site in Russia.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Aug 2023. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Etrusco, M.D. (3881614022, etruscoandrea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
continuation of pregnancy (time frame: 5 months). 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 24 Aug 2023.