Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

Overview

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.

Full Title of Study: “Long Term Obstetric, Perinatal and Surgical Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 15, 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Serosal myomectomy
    • Patients with singleton pregnancy, who had serosal myomectomy during cesarean section
  • Experimental: Endometrial myomectomy
    • Patients with singleton pregnancy, who had endometrial myomectomy during cesarean section
  • Placebo Comparator: Control group
    • Patients with singleton pregnancy, who did not have myomectomy during cesarean section

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bilge Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Oguz Guler, Principle investigator – Bilge Hospital
  • Overall Official(s)
    • Oguz Guler, M.D., Principal Investigator, Bilge Hospital

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