NCT05096910

Brief Summary

This multicenter prospective randomized controlled trial aims to investigate the ishtmocele rates after c-section delivery depending on using different suture materials for the uterine closure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

September 4, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

October 14, 2021

Last Update Submit

October 26, 2021

Conditions

Uterine Scar

Keywords

cesarean sectionisthmoceleuterine scarsuture

Outcome Measures

Primary Outcomes (1)

  • Isthmocele Rate

    diagnosis of isthmocele during 6th month ultrasound check.

    6 months

Study Arms (2)

Monofilament Suture Group

ACTIVE COMPARATOR

Monofilament sutures will be used for uterine closure.

Procedure: Uterine Closure with monofilament or polyfilament suture materials

Polyfilament Suture Group

ACTIVE COMPARATOR

Polyfilament sutures will be used for uterine closure.

Procedure: Uterine Closure with monofilament or polyfilament suture materials

Interventions

Uterine Closure with monofilament or polyfilament suture materialsPROCEDURE

Postoperative 6th-month isthmocele rates

Monofilament Suture GroupPolyfilament Suture Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • yrs women
  • Primary elective cesarean section
  • First delivery
  • Without any systemic diseases

You may not qualify if:

  • emergent delivery
  • previous c-section history
  • congenital uterine abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludag University Scholl of medicine

Bursa, Turkey/bursa, Turkey (Türkiye)

RECRUITING

Study Officials

  • Gurkan Uncu, Prof.

    Bursa Uludag University Faculty of Medicine

    STUDY DIRECTOR

Central Study Contacts

Kiper Aslan, M.D.

CONTACT

+905548127272kiperaslan@yahoo.com.tr

Tugba Kilik, M.D.

CONTACT

+905373437012tbsklk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Professor

Study Record Dates

First Submitted

October 14, 2021

First Posted

October 27, 2021

Study Start

September 4, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

October 27, 2021

Record last verified: 2021-10

Locations

TU(1)