Pain, PostoperativeNCT03306953
The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation
A study testing Rectus muscle approximation in people with Pain, Postoperative, run by Cairo University at 1 site in Egypt.
Trial summary
This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Rectus muscle approximation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2017to 20 Jan 2018
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who will undergo first elective cesarean section
- Singleton pregnancy
Who cannot join
- Previous abdominal or pelvic surgery
- Medical or psychiatric disease
- Previous pelvic inflammatory disease
- Obesity
- Allergy to analgesics
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Cairo, Greater Cairo, 11956
About this study
Official title: The Effect of Rectus Muscle Approximation at Cesarean Delivery on Postoperative Pain
This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery.
Read the detailed description
This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2 groups. Rectus muscle approximation will be done to the first group. The second group will be the control group.
- Conditions
- Pain, Postoperative
- Being tested
- Rectus muscle approximation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus muscle approximationProcedure or surgery
The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.
| Study group | Role | What they receive |
|---|---|---|
| Rectus muscle approximation | Active comparator | Three sutures will be done for the the purpose of rectus muscle approximation in cesarean section. Receives: Procedure: Rectus muscle approximation |
| Control | No intervention | No approximation for the rectus muscle will be done for the control group in cesarean section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early pain score
Early pain score will be assessed by an investigator for patients
Measured: 24 hours after cesarean section
Secondary outcomes (1)
Late pain score
Late pain score will be assessed by an investigator for patients
Measured: 48 hours 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 posted11 Oct 2017
- Study start11 Oct 2017
- Primary completion15 Jan 2018
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Omran, Cairo University
- Investigators
- Eman F Omran, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306953
- Sponsor's protocol ID
- 5678
- Status last verified
- Feb 2018
- First submitted
- 6 Oct 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rectus Muscle Approximation at Cesarean Delivery on Postoperative Pain
- ClinicalTrials.gov ID
- NCT03306953
- Acronym / sponsor ID
- 5678
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 11 Oct 2017 (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.
This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery.
Detailed description
This is a prospective randomized controlled study to determine the clinical outcome of rectus muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2 groups. Rectus muscle approximation will be done to the first group. The second group will be the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus muscle approximation | Active comparator | Procedure: Rectus muscle approximationThree sutures will be done for the the purpose of rectus muscle approximation in cesarean section. |
| Control | No intervention | –No approximation for the rectus muscle will be done for the control group in cesarean section. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women who will undergo first elective cesarean section
- Singleton pregnancy
Key exclusion criteria (5 listed)
- Previous abdominal or pelvic surgery
- Medical or psychiatric disease
- Previous pelvic inflammatory disease
- Obesity
- Allergy to analgesics
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 approximationThe surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery. | Procedure or surgery | Rectus muscle approximation |
Primary outcome
Early pain score
Time frame: 24 hours after cesarean section
Early pain score will be assessed by an investigator for patients
1 secondary outcome
Late pain score
Time frame: 48 hours after cesarean section
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 5 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Eman F Omran, M.D. principal investigator
Cairo University
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 approximation in people with Pain, Postoperative, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 5 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 5 Feb 2018. 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 Egypt. 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?
Early pain score (time frame: 24 hours 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 5 Feb 2018.