Obstetric ComplicationNCT04483986
Does Rectus Re-approximation Cause Adhesion After Cesarean Section?
A study testing Rectus muscle re-approximation in people with Obstetric Complication and Muscle Injury, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Complication, Muscle Injury
- What is being tested?
- Rectus muscle re-approximation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2020to 25 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primary cesarean section
Who cannot join
- Wound infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Rectus Re-approximation in Terms of Adhesion After Cesarean Section by Elastography.
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.
- Conditions
- Obstetric Complication, Muscle Injury
- Being tested
- Rectus muscle re-approximation
- Keywords
- elastography, rectus muscle re-approximation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus muscle re-approximationProcedure or surgery
Study group: we are going to re-approximate rectus muscle wirth minimum 3 stiches.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | This arm is going to include the patients who are performed rectus reapproximation. Receives: Procedure: Rectus muscle re-approximation |
| Control group | No intervention | This arm is going to include the patients who are not performed rectus reapproximation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after cesarean section
Secondary outcomes (4)
Operation time
Operation time in minutes is going to be recorded
Measured: During operation
Postoperative pain
VAS scale is going to be used.
Measured: 3 months after cesarean section
Postoperative bowel function
It is going to be evaluated by self developed questionnaire.
Measured: 3 months after cesarean section
Postoperative bladder function
It is going to be evaluated by self developed questionnaire.
Measured: 3 months after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start25 May 2020
- Primary completion25 Aug 2021 (estimated)
- Study completion25 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebnem Alanya Tosun, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483986
- Sponsor's protocol ID
- Rectus-reapproximation
- Status last verified
- Aug 2021
- First submitted
- 18 Jun 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Rectus Re-approximation in Terms of Adhesion After Cesarean Section by Elastography.
- ClinicalTrials.gov ID
- NCT04483986
- Acronym / sponsor ID
- Rectus-reapproximation
- Conditions
- Obstetric Complication, Muscle Injury
- Keywords
- elastography, rectus muscle re-approximation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 25 Aug 2021 (estimated)
- Study completion
- 25 Sep 2021 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: Rectus muscle re-approximationThis arm is going to include the patients who are performed rectus reapproximation. |
| Control group | No intervention | –This arm is going to include the patients who are not performed rectus reapproximation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primary cesarean section
Key exclusion criteria (1 listed)
- Wound infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectus muscle re-approximationStudy group: we are going to re-approximate rectus muscle wirth minimum 3 stiches. | Procedure or surgery | Study group |
Primary outcome
Rectus muscle stiffness
Time frame: 3 months after cesarean section
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.
4 secondary outcomes
Operation time
Time frame: During operation
Postoperative pain
Time frame: 3 months after cesarean section
Postoperative bowel function
Time frame: 3 months after cesarean section
Postoperative bladder function
Time frame: 3 months after cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Obstetric Complication
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectus muscle re-approximation in people with Obstetric Complication and Muscle Injury, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectus muscle stiffness (time frame: 3 months after cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.