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Completed

NCT Number: NCT04766567

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medicana Samsun Hospital

Samsun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cesarean section with cesarean myomectomy (serosal)

Procedure

Serosal or endometrial myomectomy performed during cesarean section

Other names: Cesarean section with cesarean myomectomy (endometrial)

Cesarean section without myomectomy

Procedure

Cesarean delivery without performing myoemctomy

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bilge Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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