Complications in Singleton Pregnancies Following Previous Cesarean Myomectomy

NCT ID: NCT04766567

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Serosal myomectomy

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

Group Type EXPERIMENTAL

Cesarean section with cesarean myomectomy (serosal)

Intervention Type PROCEDURE

Serosal or endometrial myomectomy performed during cesarean section

Endometrial myomectomy

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

Group Type EXPERIMENTAL

Cesarean section with cesarean myomectomy (serosal)

Intervention Type PROCEDURE

Serosal or endometrial myomectomy performed during cesarean section

Control group

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

Group Type PLACEBO_COMPARATOR

Cesarean section without myomectomy

Intervention Type PROCEDURE

Cesarean delivery without performing myoemctomy

Interventions

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Cesarean section with cesarean myomectomy (serosal)

Serosal or endometrial myomectomy performed during cesarean section

Intervention Type PROCEDURE

Cesarean section without myomectomy

Cesarean delivery without performing myoemctomy

Intervention Type PROCEDURE

Other Intervention Names

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Cesarean section with cesarean myomectomy (endometrial)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bilge Hospital

OTHER

Sponsor Role lead

Responsible Party

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Oguz Guler

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oguz Guler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bilge Hospital

Locations

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Medicana Samsun Hospital

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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