Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-31 @ 6:16 AM
Study NCT ID:
NCT03296969
Status:
UNKNOWN
Last Update Posted:
2017-09-29
First Post:
2017-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rectus Muscle Re-approximation at Cesarean Delivery
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
The Value of Rectus Muscle Re-approximation at Cesarean Delivery
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We include in our study 200 pregnant women, primigravidas, at term who underwent elective lower segment Cesarean section for the first time among the age group of 20 - 35 years.
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
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:
We include in our study 200 pregnant women, primigravidas, at term who underwent elective lower segment Cesarean section for the first time among the age group of 20 - 35 years.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: