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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.
Full description
AIMS:
Patients enrolled are divided in three major groups:
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
DATA TO COLLECT:
OUTCOMES:
pregnancy complications
intraoperative complications
other complications:
The study will be conducted as a multicentric observational study including cesarean section deliveries in each participating center. In each participating center, one person will be in charge for data collection and filling the SPSS database after obtaining the approval of the local Ethic Committee. As the study is observational and all the procedures will be conducted according to the local practice, informed consent from patients is not necessary.
Following data collection and termination of the study, a single researcher will oversee the SPSS data collection for all the participating centers, checking the quality of data and submitting it for statistical analysis.
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150 participants in 2 patient groups
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Central trial contact
ANDREA TINELLI, MD; Gaetano Panese, MD
Data sourced from clinicaltrials.gov
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