Pregnancy Outcomes Following Myomectomy

Launched by CENTRO DI RICERCA CLINICA SALENTINO · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different types of surgery for removing uterine fibroids (called myomectomy) affect pregnancy outcomes in women. Uterine fibroids are non-cancerous growths in the uterus that can cause various issues, including complications during pregnancy. The researchers want to find out if the method of surgery (hysteroscopic, laparoscopic, or laparotomic) and the timing of the surgery (before or during a pregnancy) influence the chances of having a healthy pregnancy. They are also comparing women who have had surgery to those who have not, to see if there are differences in pregnancy complications.

To participate in this study, women must be of reproductive age (up to 45 years old) and have undergone myomectomy or cesarean section at least two years before joining the trial. They should have fibroids that are 30 mm or larger. Participants will be followed up after surgery to check for any pregnancy complications or issues that might arise later. If you're interested in this study or think you might qualify, it's a great opportunity to contribute to understanding how surgery affects pregnancy outcomes for women with fibroids.

Gender

FEMALE

Eligibility 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