Managing uterine fibroids during pregnancy with surgery
Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study
University of Palermo · NCT06009562
This study is testing whether surgery to remove uterine fibroids during pregnancy can help women manage their symptoms and improve their pregnancy outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 28 (estimated) |
| Sex | Female |
| Sponsor | University of Palermo (other) |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06009562 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women who are pregnant and have symptomatic uterine fibroids, which can complicate their pregnancy. It aims to evaluate the outcomes of laparotomic myomectomy, a surgical procedure to remove fibroids, performed during pregnancy. The study will assess the frequency of complications and the overall management strategies for these patients, providing insights into the best practices for handling this challenging condition. By analyzing the effects of this intervention, the study seeks to improve care for pregnant women facing this issue.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with large or giant uterine fibroids causing significant symptoms or complications.
Not a fit: Patients who refuse laparotomic myomectomy or do not have an urgent indication for the procedure during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for pregnant women with symptomatic uterine fibroids, enhancing maternal and fetal outcomes.
How similar studies have performed: While there is limited data on similar approaches, the management of uterine fibroids during pregnancy remains a complex and evolving area, suggesting that this study may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Moscow
- State-Funded Health Care Facility of Moscow Region (GBUZ MO MONIIAG) — Moscow, Russian Federation (RECRUITING)
Study contacts
- Principal investigator: Andrea Etrusco, M.D. — University of Palermo
- Study coordinator: Andrea Etrusco, M.D.
- Email: etruscoandrea@gmail.com
- Phone: 3881614022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Uterine Fibroid, Pregnancy Related, Uterine fibroids, Pregnancy, myomectomy, fetal outcomes