Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study

NCT ID: NCT06009562

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-19

Study Completion Date

2024-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Fibroid Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Laparotomic myomectomy during pregnancy

Surgical removal of symptomatic uterine fibroids in pregnancy by laparotomic access

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Refusal of LPTM by the patient.
* Absence of urgent indication for LPTM during pregnancy.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Andrea Etrusco

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Etrusco, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Palermo

Antonio Simone Laganà, M.D. Ph.D.

Role: STUDY_DIRECTOR

University of Palermo

Locations

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State-Funded Health Care Facility of Moscow Region (GBUZ MO MONIIAG)

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Andrea Etrusco, M.D.

Role: CONTACT

3881614022

Facility Contacts

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Andrea Etrusco, M.D.

Role: primary

+39 388 1614022

Other Identifiers

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LPTM-S-UFs-Pregancy

Identifier Type: -

Identifier Source: org_study_id

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