Cesarean Section ComplicationsNCT03701048
Rectus Musle Reapproximation During Cesarean Section
A study testing Cesarean Section in people with Cesarean Section Complications, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated. 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
- Cesarean Section Complications
- What is being tested?
- Cesarean Section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 1 Apr 2022
- 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
- 18-40 years old women undergoing cesarean section
Who cannot join
- grandmultiparas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative and Postoperative Results of Rectus Musle Reapproximation During Cesarean Section
During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.
Read the detailed description
Pfannenstiel incision will be done under general or spinal anesthesia. The abdomen will be opened and fetus and placenta will be delivered. Then the abdomen will be closed. In Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.
- Conditions
- Cesarean Section Complications
- Being tested
- Cesarean Section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean SectionProcedure or surgery
Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed.
| Study group | Role | What they receive |
|---|---|---|
| reappoximation of rectus muscle | Active comparator | During Cesarean Section rectus muscle will be reapproximated with interrupted sutures. Receives: Procedure: Cesarean Section |
| no reappoximation of rectus muscle | Active comparator | During Cesarean Section rectus muscle will not be closed. Receives: Procedure: Cesarean Section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain: Visual Analog Score
Visual Analog Scores, minimum score is 0, maximum score is 10. Score 10 represents highest pain score.
Measured: 24 hours after the procedure
Postoperative interrectus distance
Distance between the margins of the rectus muscles in centimeters will be measured with ultrasonography
Measured: 6 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start15 Oct 2018
- Primary completion15 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Berna Aslan A Çetin, Principal investigator, KSSTRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701048
- Sponsor's protocol ID
- 2018/10
- Status last verified
- Jan 2024
- First submitted
- 6 Oct 2018
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lyell DJ, Naqvi M, Wong A, Urban R, Carvalho B. Rectus Muscle Reapproximation at Cesarean Delivery and Postoperative Pain: A Randomized Controlled Trial. Surg J (N Y). 2017 Aug 11;3(3):e128-e133. doi: 10.1055/s-0037-1604074. eCollection 2017 Jul.
PubMed 28840194
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative and Postoperative Results of Rectus Musle Reapproximation During Cesarean Section
- ClinicalTrials.gov ID
- NCT03701048
- Acronym / sponsor ID
- 2018/10
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 9 Oct 2018 (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.
During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.
Detailed description
Pfannenstiel incision will be done under general or spinal anesthesia. The abdomen will be opened and fetus and placenta will be delivered. Then the abdomen will be closed. In Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reappoximation of rectus muscle | Active comparator | Procedure: Cesarean SectionDuring Cesarean Section rectus muscle will be reapproximated with interrupted sutures. |
| no reappoximation of rectus muscle | Active comparator | Procedure: Cesarean SectionDuring Cesarean Section rectus muscle will not be closed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-40 years old women undergoing cesarean section
Key exclusion criteria (1 listed)
- grandmultiparas
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 |
|---|---|---|
| Cesarean SectionPfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. | Procedure or surgery | no reappoximation of rectus muscle, reappoximation of rectus muscle |
Primary outcome
Postoperative pain: Visual Analog Score
Time frame: 24 hours after the procedure
Visual Analog Scores, minimum score is 0, maximum score is 10. Score 10 represents highest pain score.
Postoperative interrectus distance
Time frame: 6 weeks after the procedure
Distance between the margins of the rectus muscles in centimeters will be measured with ultrasonography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 28840194Lyell DJ, Naqvi M, Wong A, Urban R, Carvalho B. Rectus Muscle Reapproximation at Cesarean Delivery and Postoperative Pain: A Randomized Controlled Trial. Surg J (N Y). 2017 Aug 11;3(3):e128-e133. doi: 10.1055/s-0037-1604074. eCollection 2017 Jul.
- Individual participant dataSharing planned: No
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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.
Berna Aslan A Çetin principal investigator
KSSTRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cesarean Section in people with Cesarean Section Complications, run by Kanuni Sultan Suleyman Training and Research Hospital 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: finished, as of the sponsor's last update on 9 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative pain: Visual Analog Score (time frame: 24 hours after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701048, which also lists 1 linked publication.
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 9 Jan 2024.