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Clinical Trials/NCT04766567
NCT04766567
Completed
Not Applicable

Long Term Obstetric, Perinatal and Surgical Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

Bilge Hospital1 site in 1 country150 target enrollmentJune 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section Complications
Sponsor
Bilge Hospital
Enrollment
150
Locations
1
Primary Endpoint
Complications of cesarean myomectomy
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
June 15, 2020
End Date
February 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Bilge Hospital
Responsible Party
Principal Investigator
Principal Investigator

Oguz Guler

Principle investigator

Bilge Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Complications of cesarean myomectomy

Time Frame: Post-cesarean 12 months

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

Study Sites (1)

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