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Uterine 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
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. being nulliparous
  2. having singleton fetus
  3. not having diabetes and or hypertension
  4. not having an intrauterine infection
  5. body mass index <35 kg/m2
  6. not having any placental insertion anomalies
  7. not having Mullerian anomalies
  8. active phase of labor is not started.
  9. no previous uterine surgeries

Exclusion Criteria:

  1. being multiparous
  2. having multiple pregnancies
  3. having diabetes and or hypertension
  4. having an intrauterine infection
  5. body mass index >=35 kg/m2
  6. having any placental insertion anomalies
  7. having Mullerian anomalies
  8. in active phase of labor
  9. 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

First Posted
October 15, 2021
Last Updated
October 28, 2021
Sponsor
Mersin University
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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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