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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06009562
Other study ID # LPTM-S-UFs-Pregancy
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 19, 2023
Est. completion date January 1, 2024

Study information

Verified date August 2023
Source University of Palermo
Contact Andrea Etrusco, M.D.
Phone 3881614022
Email etruscoandrea@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date January 1, 2024
Est. primary completion date August 19, 2023
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laparotomic myomectomy during pregnancy
Surgical removal of symptomatic uterine fibroids in pregnancy by laparotomic access

Locations

Country Name City State
Russian Federation State-Funded Health Care Facility of Moscow Region (GBUZ MO MONIIAG) Moscow

Sponsors (1)

Lead Sponsor Collaborator
University of Palermo

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary continuation of pregnancy Pregnancy continuation after surgery. 5 months
Secondary Fetal outcome Assessed by APGAR 1 and 5 min, birth weight, and fetal conformation. 5 months
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