Back to resultsUterine Closure Techniques and Cesarean Scar Defect Risk
Primary Purpose
Cesarean Section Complications, Scar; Deformity
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Uterine closure during Cesarean section
Sponsored by
About this trial
This is an interventional treatment trial for Cesarean Section Complications focused on measuring cesarean scar defect, cesarean section, uterine closure techniques
Eligibility Criteria
Inclusion Criteria:
- being nulliparous
- having singleton fetus
- not having diabetes and or hypertension
- not having an intrauterine infection
- body mass index <35 kg/m2
- not having any placental insertion anomalies
- not having Mullerian anomalies
- active phase of labor is not started.
- no previous uterine surgeries
Exclusion Criteria:
- being multiparous
- having multiple pregnancies
- having diabetes and or hypertension
- having an intrauterine infection
- body mass index >=35 kg/m2
- having any placental insertion anomalies
- having Mullerian anomalies
- in active phase of labor
- having previous uterine surgeries
Sites / Locations
- Mersin University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
The uterotomy suture technique is continous, double layer suturing, in which the first layer is continuous and unlocked involving all uterine layers and a second, continuous non-locking imbrictating layer is applied over the first suture.
The uterotomy suture technique is continous, double layer suturing, in which the first layer is continuous and unlocked not including decidua and a second, continuous non-locking imbrictating layer is applied over the first suture.
The uterotomy suture technique is continous ,double layer with the first layer unlocked, excluding the decidua and including the deep part of the myometrium, and the second layer unlocked including the remaining part of the myometrium.
Outcomes
Primary Outcome Measures
Scar thickness at postpartum 6th week
The patients will be examined at the postpartum sixth week. During that visit uterine scar thickness will be measured by ultrasound. Measurement of uterine scar thickness will be performed perpendicular to the uterine wall and calipers will be placed on the serosal surface of the uterus and the delineation of the endometrium. These landmarks represent the inner and outer edge of the Cesarean scar.
Scar thickness at postpartum 6th month
The patients will be reexamined at the postpartum sixth month. During that visit uterine scar thickness will be measured again. Measurement of uterine scar thickness will be performed with the same method (perpendicular to the uterine wall and calipers will be placed on the serosal surface of the uterus and the delineation of the endometrium. These landmarks represent the inner and outer edge of the Cesarean scar.)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05100147
Brief Title
Uterine Closure Techniques and Cesarean Scar Defect Risk
Official Title
Comparison of Uterine Closure Techniques During Cesarean Section With Respect to the Development of Cesarean Scar Defects a Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cesarean operations are one of the most common obsetric operations and have an increasing trend in all over the world. However unfortunately the operation techniques have not been standardized yet. It is well known that different uterine closure techniques result in differences with respect to wound healing on the uterus; however, the ideal uterine closure technique is yet not known. The aim of this study is to assess the results of different uterine closure techniques during cesarean section with respect to the development of cesarean scar defects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications, Scar; Deformity
Keywords
cesarean scar defect, cesarean section, uterine closure techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
The uterotomy suture technique is continous, double layer suturing, in which the first layer is continuous and unlocked involving all uterine layers and a second, continuous non-locking imbrictating layer is applied over the first suture.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
The uterotomy suture technique is continous, double layer suturing, in which the first layer is continuous and unlocked not including decidua and a second, continuous non-locking imbrictating layer is applied over the first suture.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
The uterotomy suture technique is continous ,double layer with the first layer unlocked, excluding the decidua and including the deep part of the myometrium, and the second layer unlocked including the remaining part of the myometrium.
Intervention Type
Procedure
Intervention Name(s)
Uterine closure during Cesarean section
Intervention Description
The uterotomy is sutured after the delivery of the fetus and the placenta with an appropriate delayed absorbable suture (number 1 polyglactin 910)
Primary Outcome Measure Information:
Title
Scar thickness at postpartum 6th week
Description
The patients will be examined at the postpartum sixth week. During that visit uterine scar thickness will be measured by ultrasound. Measurement of uterine scar thickness will be performed perpendicular to the uterine wall and calipers will be placed on the serosal surface of the uterus and the delineation of the endometrium. These landmarks represent the inner and outer edge of the Cesarean scar.
Time Frame
Postpartum 6th weeks
Title
Scar thickness at postpartum 6th month
Description
The patients will be reexamined at the postpartum sixth month. During that visit uterine scar thickness will be measured again. Measurement of uterine scar thickness will be performed with the same method (perpendicular to the uterine wall and calipers will be placed on the serosal surface of the uterus and the delineation of the endometrium. These landmarks represent the inner and outer edge of the Cesarean scar.)
Time Frame
Postpartum 6th months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
being nulliparous
having singleton fetus
not having diabetes and or hypertension
not having an intrauterine infection
body mass index <35 kg/m2
not having any placental insertion anomalies
not having Mullerian anomalies
active phase of labor is not started.
no previous uterine surgeries
Exclusion Criteria:
being multiparous
having multiple pregnancies
having diabetes and or hypertension
having an intrauterine infection
body mass index >=35 kg/m2
having any placental insertion anomalies
having Mullerian anomalies
in active phase of labor
having previous uterine surgeries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Aytan, Prof.
Phone
+905056833866
Email
drhakanaytan@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meltem Nass Duce, Prof.
Phone
+903242410000
Email
mnduce@mersin.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ezgi Oktay, MD
Organizational Affiliation
Mersin University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mersin University Hospital
City
Mersin
ZIP/Postal Code
33170
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meltem Nass Duce, Prof.
Phone
+903242410000
Email
mnduce@mersin.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
No
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Uterine Closure Techniques and Cesarean Scar Defect Risk
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