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Trial Title:
Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study
NCT ID:
NCT06009562
Condition:
Uterine Fibroid
Pregnancy Related
Conditions: Official terms:
Leiomyoma
Myofibroma
Conditions: Keywords:
Uterine fibroids
Pregnancy
myomectomy
fetal outcomes
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Laparotomic myomectomy during pregnancy
Description:
Surgical removal of symptomatic uterine fibroids in pregnancy by laparotomic access
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.
Criteria for eligibility:
Study pop:
pregnant women with symptomatic uterine fibroids (UFs)
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Gender based:
Yes
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
State-Funded Health Care Facility of Moscow Region (GBUZ MO MONIIAG)
Address:
City:
Moscow
Zip:
101000
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Andrea Etrusco, M.D.
Phone:
+39 388 1614022
Email:
etruscoandrea@gmail.com
Start date:
August 19, 2023
Completion date:
January 1, 2024
Lead sponsor:
Agency:
University of Palermo
Agency class:
Other
Source:
University of Palermo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06009562
