Investigating pregnancy outcomes after myomectomy for uterine fibroids
Pregnancy Outcomes Following Hysteroscopic, Laparoscopic and Laparotomic Myomectomy
This study is trying to see how different types of surgery for uterine fibroids affect pregnancy outcomes for women who have had the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | Female |
| Sponsor | Centro di Ricerca Clinica Salentino Research network |
| Locations | 1 site (Lecce, Le) |
| Trial ID | NCT06474065 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the pregnancy outcomes of women who have undergone myomectomy for uterine fibroids. It will compare outcomes based on the surgical approach used—hysteroscopic, laparoscopic, or laparotomic—and the timing of the procedure, whether performed on a pregnant or non-pregnant uterus. Participants will be divided into groups based on their surgical history and will be monitored for pregnancy outcomes. The study seeks to clarify the impact of myomectomy on future pregnancies.
Who should consider this trial
Good fit: Ideal candidates include women of reproductive age up to 45 years who have undergone myomectomy or cesarean myomectomy at least two years prior.
Not a fit: Patients with a history of reproductive organ surgery other than myomectomy or those with conditions like endometriosis or coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into how different myomectomy techniques affect pregnancy outcomes, potentially guiding treatment decisions for women with fibroids.
How similar studies have performed: While numerous studies have explored myomectomy and pregnancy outcomes, this specific observational approach focusing on surgical technique and timing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. women of reproductive age (up to 45 yrs)-all groups 2. women who had myomectomy (group A and B)/CS (group C) at least two years before the enrolment 3. myomas 30 mm in size and larger (groups A and B) 4. Study groups: myomectomy performed as hysteroscopic/laparoscopic/laparotomic myomectomy or cesarean myomectomy, both using transendometrial or serosal approach: gravida 2 para 2 or gravida 1 para 1 \[groups A1, A2, A3 and groups B1 and B2\] 5. Control group: women who had cesarean section in their second pregnancy-para 2 gravida 2, at least two years after the CS \[group C\] Exclusion Criteria: 1. any previous surgery on reproductive organs except myomectomy 2. any additional operation during cesarean myomectomy procedure except cesarean section 3. history of endometriosis or PID 4. coagulation disorders 5. previous treatment for any malignant disease 6. previous GTD 7. premature ovarian failure or any kind of ovarian insufficiency necessitating oocyte donation 8. systemic diseases: IBD, MS, DM
Where this trial is running
Lecce, Le
- Andrea Tinelli — Lecce, Le, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea Tinelli, MD — Centro di Ricerca Clinica Salentino
- Study coordinator: Andrea Tinelli, Md
- Email: andreatinelli@gmail.com
- Phone: +393392074078
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.