Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

Not Applicable

Completed

• Conditions: Cesarean Section Complications
• Interventions: Procedure: Cesarean section with cesarean myomectomy (serosal); Procedure: Cesarean section without myomectomy

• Registration Number: NCT04766567
• Lead Sponsor: Bilge Hospital

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.

Study Timeline

• Study Start: 2020-06-15
• Primary Completion: 2021-01-15
• Status Verified: 2021-02
• Study Completion: 2021-02-01
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-21
• Last Update Submitted: 2021-02-21
• Study First Posted: 2021-02-23
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serosal myomectomy	Cesarean section with cesarean myomectomy (serosal)	Patients with singleton pregnancy, who had serosal myomectomy during cesarean section
Endometrial myomectomy	Cesarean section with cesarean myomectomy (serosal)	Patients with singleton pregnancy, who had endometrial myomectomy during cesarean section
Control group	Cesarean section without myomectomy	Patients with singleton pregnancy, who did not have myomectomy during cesarean section

Primary Outcome Measures

Name	Time	Method
Complications of cesarean myomectomy	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

Trial Locations

Locations (1)

Medicana Samsun Hospital; 🇹🇷 Samsun, Turkey