The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study

NCT ID: NCT04455321

Last Updated: 2021-02-09

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

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-15

Study Completion Date

2021-01-15

Brief Summary

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This study aims to investigate the effect of suture materials with different absorption times on istmocel.

Detailed Description

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Conditions

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Suture, Complication Istmocel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Rapid vicryl will used in study group and vicryl will used in control group for uterine closure in cesarean section.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vicryl

Single layer locked uterine closure with vicryl suture material

Group Type ACTIVE_COMPARATOR

Suture materials effect on istmocel

Intervention Type PROCEDURE

Effect of suture materials with different absorption times on istmocel

rapide vicryl

Single layer locked uterine closure with rapide vicryl suture material

Group Type EXPERIMENTAL

Suture materials effect on istmocel

Intervention Type PROCEDURE

Effect of suture materials with different absorption times on istmocel

Interventions

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Suture materials effect on istmocel

Effect of suture materials with different absorption times on istmocel

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* primary cesarean section
* single pregnancy
* 18-45 age

Exclusion Criteria

* Diabetes mellitus disease
* inflammatory bowel disease
* systemic lupus erythematosus disease
* rheumatoid arthritis disease
* previous uterine surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Selçuk Yetkinel

MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baskent University Adana Dr. Turgut Noyan Hospital

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KA19/170

Identifier Type: -

Identifier Source: org_study_id

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