Study Results
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Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2022-04-20
2023-04-01
Brief Summary
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Detailed Description
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Currently, a low-transverse incision is the preferred method of hysterotomy during caesarean delivery. This incision has traditionally been repaired with a two-layer closure. A two-layer closure usually involves a continuous, unlocking layer of absorbable suture with an addition of adds muscular fold to cover the first layer. Studies showed that women whose uterine incisions have been closed by double-layer following caesarean section experienced greater advantages in terms of residual myometrium thickness, healing ratio (residual myometrium thickness/adjacent myometrium thickness), and dysmenorrhea .
The safe cut off thickness of scar in post LSCS uterus varies from 1.5 to 3.5 mm; the thinning of the site is the cause of worry of dehiscence scar or rupture in next pregnancy. Closure of the uterine incision is a key step in caesarean delivery, correct approximation of the cut margins is not guaranteed .
This may be possibly due to edges getting overlapped; and, after remodelling and the process of the healing, thickness of the site of incision is significantly reduced. There is also a very high possibility of inter surgeon variability. It was felt that if there is a suturing technique which ensures correct approximation of all the layers with nil or minimal possibility of inters operator variability, there will not be any thinning of lower segment caesarean section LSCS site, and scarred uterus repaired in this manner will be able to withstand the stress of labor in future .
A growing body of evidence suggests that the surgical technique for uterus closure influences uterine scar defect, but there is still no consensus about optimal uterus closure. Some techniques seem to have the potential to decrease the risk of short-term complications, while others have long-term benefits, such as reduced risk of uterine rupture. Some maternal symptoms are related to the appearance of the uterine scar, and more specifically to a niche in the caesarean scar as a surrogate marker. niche is defined as an indentation in the myometrium of ≥2 mm in depth and is detectable by transvaginal ultrasound (TVUS), preferably with contrast to limit false negatives. Complications in subsequent pregnancies, including uterine rupture and placenta accreta spectrum disorders, are associated with thin residual myometrium .
Many variations in CS technique have been studied. For example, single-layer unlocked uterine incision closure has been compared to double-layer unlocked uterine incision closure. Double layer locked closure has compared to single-layer locked closure, Fear of scar rupture is one of risks involved in a post caesarean pregnancy .
This had led to an increased rate of repeat caesarean delivery in today's times. Closure of the uterine incision is a key step in caesarean section, and it is imperative that an optimal surgical technique be employed for closing a uterine scar. This technique should be able to withstand the stress of subsequent labor. In the existing techniques of uterine closure, single or double layer, correct approximation of the cut margins, that is, decidua-to-decidua, myometrium to myometrium, serosa to serosa is not guaranteed. Also, there are high chances of inter surgeon variability. It was felt that if a suturing technique which ensures correct approximation of all the layers mentioned above with nil or minimal possibility of inter operator variability existed, there will not be any thinning of lower segment caesarean section (LSCS). Further, a scarred uterus repaired in this manner will be able to withstand the stress of labor in future .
To assess the healing of scar and the risk of uterine rupture and other complication, ultrasonography is used in the evaluation of uterine scar 6 weeks after delivery. It has generally been found that, the thicker the uterine scar, the lower the rate of complications. This may be due to that the thicker scar is stronger, and thus performs better than a thinner one .
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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o Group (1): 30 cases who will undergo Two Layer Uterine Closure
o After the delivery the first group will undergo Two Layer Uterine Closure: Double-layer closure of the uterine incision will be performed using unlocked continuous Polyglactin thread sutures(1/0) for both layers, with a large portion of the myometrium and the endometrium included in the first layer. The second layer was a continuous running suture that imbricate the first layer, including serosal and myometrial tissue.
Closure of cesarean section incision
After the delivery the first group will undergo Two Layer Uterine Closure:
Double-layer closure of the uterine incision will be performed using unlocked continuous Polyglactin thread sutures(1/0) for both layers, with a large portion of the myometrium and the endometrium included in the first layer. The second layer was a continuous running suture that imbricate the first layer, including serosal and myometrial tissue.
The second group will undergo continuous unlocked sutures in a single layer, Uterine closure will begin from one corner of the incision and then the uterine incision wound is closed using Polyglactin thread include endometrium, myometrium and serosa.
o Group (2): 30 cases who will undergo single layer uterine closure.
The second group will undergo continuous unlocked sutures in a single layer, Uterine closure will begin from one corner of the incision and then the uterine incision wound is closed using Polyglactin thread include endometrium, myometrium and serosa
Closure of cesarean section incision
After the delivery the first group will undergo Two Layer Uterine Closure:
Double-layer closure of the uterine incision will be performed using unlocked continuous Polyglactin thread sutures(1/0) for both layers, with a large portion of the myometrium and the endometrium included in the first layer. The second layer was a continuous running suture that imbricate the first layer, including serosal and myometrial tissue.
The second group will undergo continuous unlocked sutures in a single layer, Uterine closure will begin from one corner of the incision and then the uterine incision wound is closed using Polyglactin thread include endometrium, myometrium and serosa.
Interventions
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Closure of cesarean section incision
After the delivery the first group will undergo Two Layer Uterine Closure:
Double-layer closure of the uterine incision will be performed using unlocked continuous Polyglactin thread sutures(1/0) for both layers, with a large portion of the myometrium and the endometrium included in the first layer. The second layer was a continuous running suture that imbricate the first layer, including serosal and myometrial tissue.
The second group will undergo continuous unlocked sutures in a single layer, Uterine closure will begin from one corner of the incision and then the uterine incision wound is closed using Polyglactin thread include endometrium, myometrium and serosa.
Eligibility Criteria
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Inclusion Criteria
* Gestational age between 37 completed weeks to 42 weeks.
* Patients undergoing elective primary caesarean section.
Exclusion Criteria
* History of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section).
* Presence of maternal disease (diabetes mellitus, connective tissue disorders, uterine malformations).
* Women Diagnosed with Placenta Accreta Spectrum during the current pregnancy
* Multiple pregnancy.
* Chorioamnionitis.
16 Years
50 Years
FEMALE
Yes
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Sara AbdelRazek Ramadan Hamad
The principal investigator
Principal Investigators
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Mohamed Hamed, Asst . Prof
Role: STUDY_DIRECTOR
Ain Shams Maternity Hospital
Locations
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Sara abdelrazik Ramadan hamad
Cairo, , Egypt
Countries
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Central Contacts
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Mohamed Hamed, Asst . Prof
Role: CONTACT
Facility Contacts
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Other Identifiers
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3/3
Identifier Type: -
Identifier Source: org_study_id
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