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

Pregnancy Related Clinical Trial

— LPTM-UFs-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009562
• Other study ID #: LPTM-S-UFs-Pregancy
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Leiomyoma
• Pregnancy Related
• Uterine Fibroid

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