NCT04483986

Brief Summary

Rectus re-approximation and periton closure are not the obligatory steps during cesarean section. These steps are due to surgeon's preference. However, there is lack of knowledge about the relation of rectus muscle re-approximation and adhesion formation. We are going to study the rectus muscle stiffness by share-wave elastosonography.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

June 18, 2020

Last Update Submit

August 4, 2021

Conditions

Obstetric ComplicationMuscle Injury

Keywords

elastographyrectus muscle re-approximation

Outcome Measures

Primary Outcomes (1)

  • Rectus muscle stiffness

    Share wave elastosonography is going to perform to six different points of rectus muscle. Each points will be 2 cm right or left side of linea alba line in horizontal axis. Two points are on cesarean section incision, next two points 2 cm below the incision and other next two points 2 cm above the incision in vertical axis. Rectus muscle stiffness will show the adhesion formation.

    3 months after cesarean section

Secondary Outcomes (4)

  • Operation time

    During operation

  • Postoperative pain

    3 months after cesarean section

  • Postoperative bowel function

    3 months after cesarean section

  • Postoperative bladder function

    3 months after cesarean section

Study Arms (2)

Study group

ACTIVE COMPARATOR

This arm is going to include the patients who are performed rectus reapproximation.

Procedure: Rectus muscle re-approximation

Control group

NO INTERVENTION

This arm is going to include the patients who are not performed rectus reapproximation.

Interventions

Rectus muscle re-approximationPROCEDURE

Study group: we are going to re-approximate rectus muscle wirth minimum 3 stiches.

Study group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primary cesarean section

You may not qualify if:

  • Wound infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sebnem Alanya Tosun

Giresun, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Radiologist is blind.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 18, 2020

First Posted

July 23, 2020

Study Start

May 25, 2020

Primary Completion

August 25, 2021

Study Completion

September 25, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)