Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

NCT04766567 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

Cesarean section; Cesarean myomectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Serosal myomectomy

EXPERIMENTAL

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

Procedure: Cesarean section with cesarean myomectomy (serosal)

Endometrial myomectomy

EXPERIMENTAL

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

Procedure: Cesarean section with cesarean myomectomy (serosal)

Control group

PLACEBO COMPARATOR

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

Procedure: Cesarean section without myomectomy

Interventions

Cesarean section with cesarean myomectomy (serosal) PROCEDURE

Serosal or endometrial myomectomy performed during cesarean section

Also known as: Cesarean section with cesarean myomectomy (endometrial)

Endometrial myomectomy; Serosal myomectomy

Cesarean section without myomectomy PROCEDURE

Cesarean delivery without performing myoemctomy

Control group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bilge Hospital: lead

Study Sites (1)

Medicana Samsun Hospital

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Cesarean Section; Uterine Myomectomy

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Oguz Guler, M.D.

  Bilge Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 23, 2021
• Study Start: June 15, 2020
• Primary Completion: January 15, 2021
• Study Completion: February 1, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)