Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
200 participants
INTERVENTIONAL
2017-10-31
2018-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The patients are divided randomly into two groups as follows:
* Group (A): undergoing rectus muscle re-approximation
* Group (B): not undergoing rectus muscle re-approximation
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The patients are divided randomly into two groups as follows:
* Group (A): undergoing rectus muscle re-approximation
* Group (B): not undergoing rectus muscle re-approximation
* Examination for diastasis recti abdominis is done for all included patients before delivery, at 6 weeks, and 6 months postpartum. The women are tested in a standardized supine position with arms crossed over the chest. They are instructed to perform an abdominal crunch till the shoulder blades are off the bench. Then we measure the inter-recti distance. If there is no separation or separation ˂ 2 finger breadths so, there is no diastasis recti abdominis. But if the separation is more than 2 finger breadths or more than 4.5 cm so, this is considered diastasis recti abdominis.
The same surgical techniques are used for both groups. All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rectus muscle approximation
All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide
cesarean section
All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide
Rectus muscle approximation
aprroximation of the lower parts of rectus abdomius muscles during cesarean section
rectus muscle non approximation
All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide
cesarean section
All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cesarean section
All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide
Rectus muscle approximation
aprroximation of the lower parts of rectus abdomius muscles during cesarean section
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* undergoing elective Cesarean section
Exclusion Criteria
18 Years
39 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Maged
professor
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13
Identifier Type: -
Identifier Source: org_study_id