Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

Bilge Hospital

Status: Completed

Conditions: Cesarean Section Complications

Treatments: Procedure: Cesarean section with cesarean myomectomy (serosal); Procedure: Cesarean section without myomectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04766567

1

Details and patient eligibility

About

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 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups, including a placebo group

Serosal myomectomy

Experimental group

Description:

Patients with singleton pregnancy, who had serosal myomectomy during cesarean section

Treatment:

Procedure: Cesarean section with cesarean myomectomy (serosal)

Endometrial myomectomy

Experimental group

Description:

Patients with singleton pregnancy, who had endometrial myomectomy during cesarean section

Treatment:

Procedure: Cesarean section with cesarean myomectomy (serosal)

Control group

Placebo Comparator group

Description:

Patients with singleton pregnancy, who did not have myomectomy during cesarean section

Treatment:

Procedure: Cesarean section without myomectomy