CClinicalTrials.gg
Status unknownNCT04483986Updated Aug 6, 2021

Does Rectus Re-approximation Cause Adhesion After Cesarean Section?

An interventional study of Rectus muscle re-approximation in Obstetric Complication and Muscle Injury, sponsored by Giresun University. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-06.

Sponsored by Giresun University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Obstetric Complication
  • Muscle Injury

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Keywords

  • elastography
  • rectus muscle re-approximation
03

In context

Tissue Adhesions

241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 184 interventional studies indexed under Tissue Adhesions.

Browse Tissue Adhesions studies →

Lead sponsor

Giresun University is the lead sponsor of 51 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Primary cesarean section

Exclusion criteria

Exclusion Criteria:

  • Wound infection
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Study group

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

    Procedure: Rectus muscle re-approximation

  • No intervention
    Control group

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

Interventions

  • ProcedureRectus muscle re-approximation

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

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What researchers measure

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.

    Time frame: 3 months after cesarean section

Secondary outcomes

  1. Operation time

    Operation time in minutes is going to be recorded

    Time frame: During operation

  2. Postoperative pain

    VAS scale is going to be used.

    Time frame: 3 months after cesarean section

  3. Postoperative bowel function

    It is going to be evaluated by self developed questionnaire.

    Time frame: 3 months after cesarean section

  4. Postoperative bladder function

    It is going to be evaluated by self developed questionnaire.

    Time frame: 3 months after cesarean section

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Study locations

1 site
  • Sebnem Alanya Tosun
    Giresun, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04483986
Lead sponsor
Giresun University
Responsible party
Sebnem Alanya Tosun (Assistant Professor, Giresun University) — Principal investigator
First posted
Jul 23, 2020
Start date
May 25, 2020
Primary completion
Aug 25, 2021 (estimated)
Completion
Sep 25, 2021 (estimated)
Last update
Aug 6, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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