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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04766567
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date February 1, 2021

Study information

Verified date February 2021
Source Bilge Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study aims to investigate whether there is a difference in short- and long-term complications in patients undergoing cesarean myomectomy (endometrial or serosal myomectomy) during cesarean section.


Description:

Myomectomy is frequently performed during cesarean section. Infertility, myoma recurrence, adhesions , uterine rupture (complete/incomplete), impaired uterine healing (partial or complete dehiscence/poor/good), placental abnormalities, and perinatal complications in subsequent pregnancy are may be associated with cesarean myomectomy. In this study, patients who underwent cesarean myomectomy during cesarean section in our institute were analyzed in a retrospective manner. Patients were divided into three groups as those receiving serosal myomectomy, endometrial myomectomy and those who only underwent cesarean section. The groups were compared with respect to the presence of adhesion formation, time to achieve pregnancy (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental abnormalities.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date February 1, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Participants should have singleton pregnancy delivered by cesarean section - Cesarean section technique should include: Transverse hysterotomy to enter the uterine cavity, single layer closure of the uterine wall, non-sutured visceral and parietal peritoneum - Myomectomy during cesarean section should include: only patients, who have undergone a single myomectomy and have been applied a single layer suture technique with the preservation of the pseudocapsule-for all cesarean myomectomy cases Exclusion Criteria: - Patients having history of any malignancy - Patients with coagulation disorders - Patients with a history of previous intraabdominal surgery on reproductive organs - Patients with a history of endometriosis

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cesarean section with cesarean myomectomy (serosal)
Serosal or endometrial myomectomy performed during cesarean section
Cesarean section without myomectomy
Cesarean delivery without performing myoemctomy

Locations

Country Name City State
Turkey Medicana Samsun Hospital Samsun

Sponsors (1)

Lead Sponsor Collaborator
Bilge Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complications of cesarean myomectomy The difference in the rate of complications associated with the cesarean myomectomy (presence of adhesion formation, time to achieve pregnancy (fertility), morphology of the myomectomy scar, presence of uterine rupture and placental abnormalities) in patients undergoing endometrial myomectomy, serosal myomectomy, or not receiving myomectomy during cesarean section Post-cesarean 12 months
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