Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766567
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cesarean Section Complications

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