Pregnancy Outcomes Following Myomectomy (NCT06474065) | Clinical Trial Compass
CompletedNot Applicable
Pregnancy Outcomes Following Myomectomy
Italy150 participantsStarted 2024-06-28
Plain-language summary
The most prevalent genital pathology, uterine fibroids have a detrimental impact on the health of women. Fibroid symptoms are typically more impactful on females and frequently require uterine excision. Although contentious in terms of how it affects pregnancy outcomes, hysteroscopic, laparoscopic, or laparotomic myomectomy has always been a necessary and suitable procedure for the patient's health. Numerous studies have been conducted on the topic, but no clear findings have been reached.
The goal of this observational study is to investigate the pregnancy outcomes after hysteroscopic, laparoscopic, laparotomic myomectomies in female patients affected by fibroids. The main questions it aims to answer are:
To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.
To investigate whether pregnancy outcome is different in relation to time when myomectomy was performed: on a pregnant uterus or on a non-gravid uterus.
If there is a comparison group: Researchers will compare a group of patients unsubmitted to surgery, to see the difference with the operated patients.
Participants will follow up, to evaluate the possible pregnancy complications, the intraoperative complications and other perinatal and post-operative complications.
Who can participate
Age range25 Years â 45 Years
SexFEMALE
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Inclusion criteria
â. women of reproductive age (up to 45 yrs)-all groups
â. women who had myomectomy (group A and B)/CS (group C) at least two years before the enrolment
â. myomas 30 mm in size and larger (groups A and B)
â. 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 \[groups A1, A2, A3 and groups B1 and B2\]
â. 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
â. any previous surgery on reproductive organs except myomectomy
â. any additional operation during cesarean myomectomy procedure except cesarean section