Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT03930134
Status:
COMPLETED
Last Update Posted:
2020-01-10
First Post:
2019-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sparse Uterine Closure in Cesarean Section
Sponsor:
University Tunis El Manar
Organization:
Study Overview
Official Title:
Sparse Uterine Closure in Caesarean Section: Short and Mid Term Results
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
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:
The existence and the characteristics of a wedge- shaped defect in the uterine incision scar were demonstrated by radiologic, ultrasonographic, endoscopic and histologic methods by various authors.
Cesarean scar defect is a deficient uterine scar or scar dehiscence following a cesarean section involving myometrial discontinuity at the site of a previous cesarean section scar. Cesarean scar defects may be associated with many clinical problems such as ectopicpregnancy at the cesarean section scar, rupture of the uterus during a subsequent pregnancy, dysmenorrhea and abnormal uterine bleeding during the non-pregnant state. These complications are likely to be associated with poor uterine scar healing following cesarean sections.
Methods concerning closure of the uterine incision need to be considered with regards to benefit and potential harm in order to offer the best available surgical care to women undergoing cesarean section.
Sur-gical suturing technique and mechanical tension affecting the surgical wound are the most important factors related to the incisional integrity.
For this reason, investigators designed this prospective clinical study to analyze the effects of two different uterine suturing techniques. their aim was to compare the sparse closure of the uterine incision to classical one layer closure regarding short , mid and long term results. In deed, they compared :
* duration of surgery and calculated blood loss during surgery as short term results - incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
* Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy of these patients as long-term results.
Cesarean scar defect is a deficient uterine scar or scar dehiscence following a cesarean section involving myometrial discontinuity at the site of a previous cesarean section scar. Cesarean scar defects may be associated with many clinical problems such as ectopicpregnancy at the cesarean section scar, rupture of the uterus during a subsequent pregnancy, dysmenorrhea and abnormal uterine bleeding during the non-pregnant state. These complications are likely to be associated with poor uterine scar healing following cesarean sections.
Methods concerning closure of the uterine incision need to be considered with regards to benefit and potential harm in order to offer the best available surgical care to women undergoing cesarean section.
Sur-gical suturing technique and mechanical tension affecting the surgical wound are the most important factors related to the incisional integrity.
For this reason, investigators designed this prospective clinical study to analyze the effects of two different uterine suturing techniques. their aim was to compare the sparse closure of the uterine incision to classical one layer closure regarding short , mid and long term results. In deed, they compared :
* duration of surgery and calculated blood loss during surgery as short term results - incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
* Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy of these patients as long-term results.
Detailed Description:
This is a secondary analyse of a first randomised trial comparing two caesarean techniques :
* Misgav Ladach with a one layer classic uterine closure.
* French ambulatory Caesarean section with a sparse uterine closure . The first trial is registred under the reference number : NCT03741907. 100 patients with an indication of an elective caesarean section were included in this trial : 50 had a one layer classic uterine closure and are enrolled in groupe 1 and 50 had a sparse uterine closure and are enrolled in groupe 2 .
* For the short term results investigators compared : duration of uterine sutures , visually estimated and calculated blood loss
* For the mid term results investigators are shuduling for all partient an hysterosonography 6 mounths after surgery and then will compare : incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
* For the long term results investigators will interview patients 2 years after surgery in order to check for Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy .
* Misgav Ladach with a one layer classic uterine closure.
* French ambulatory Caesarean section with a sparse uterine closure . The first trial is registred under the reference number : NCT03741907. 100 patients with an indication of an elective caesarean section were included in this trial : 50 had a one layer classic uterine closure and are enrolled in groupe 1 and 50 had a sparse uterine closure and are enrolled in groupe 2 .
* For the short term results investigators compared : duration of uterine sutures , visually estimated and calculated blood loss
* For the mid term results investigators are shuduling for all partient an hysterosonography 6 mounths after surgery and then will compare : incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
* For the long term results investigators will interview patients 2 years after surgery in order to check for Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy .
Study Oversight
Has Oversight DMC:
False
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?: