Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

February 21, 2021 updated by: Oguz Guler, Bilge Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey
        • Medicana Samsun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serosal myomectomy
Patients with singleton pregnancy, who had serosal myomectomy during cesarean section
Procedure: Cesarean section with cesarean myomectomy (serosal)
Serosal or endometrial myomectomy performed during cesarean section
Other Names:
  • Cesarean section with cesarean myomectomy (endometrial)
Experimental: Endometrial myomectomy
Patients with singleton pregnancy, who had endometrial myomectomy during cesarean section
Procedure: Cesarean section with cesarean myomectomy (serosal)
Serosal or endometrial myomectomy performed during cesarean section
Other Names:
  • Cesarean section with cesarean myomectomy (endometrial)
Placebo Comparator: Control group
Patients with singleton pregnancy, who did not have myomectomy during cesarean section
Procedure: Cesarean section without myomectomy
Cesarean delivery without performing myoemctomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-cesarean 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bilge Hospital

Investigators

  • Principal Investigator: Oguz Guler, M.D., Bilge Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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