NCT04455321

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

June 29, 2020

Last Update Submit

February 5, 2021

Conditions

Suture, ComplicationIstmocel

Keywords

rapidsuture materialistmocel

Outcome Measures

Primary Outcomes (1)

  • Istmocel

    Istmocel area measurement with saline-infusion ultrasonography

    Six months

Study Arms (2)

Vicryl

ACTIVE COMPARATOR

Single layer locked uterine closure with vicryl suture material

Procedure: Suture materials effect on istmocel

rapide vicryl

EXPERIMENTAL

Single layer locked uterine closure with rapide vicryl suture material

Procedure: Suture materials effect on istmocel

Interventions

Suture materials effect on istmocelPROCEDURE

Effect of suture materials with different absorption times on istmocel

Vicrylrapide vicryl

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • primary cesarean section
  • single pregnancy
  • age

You may not qualify if:

  • Diabetes mellitus disease
  • inflammatory bowel disease
  • systemic lupus erythematosus disease
  • rheumatoid arthritis disease
  • previous uterine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Adana Dr. Turgut Noyan Hospital

Adana, 01000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Rapid vicryl will used in study group and vicryl will used in control group for uterine closure in cesarean section.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 2, 2020

Study Start

March 15, 2020

Primary Completion

August 1, 2020

Study Completion

January 15, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)