- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734366
Effect of Baseball Suturing on Isthmocele and Residual Myometrial Thickness After Cesarean
Effect of the Baseball Suturing Technique on the Incidence of Isthmocele and Residual Myometrial Thickness After Cesarean: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a double-blind randomized prospective and cross-sectional. Cesarean delivery planned patients who will admit to the Obstetrics and Gynecology Clinic, Tokat Gaziosmanpasa University Research and Application Center between January 2021 and June 2021 will be evaluated. Participation of the patients in the study will be based on written consents. All patients who meet the inclusion criteria will be randomized into two groups (i.e., "baseball" or single layer locked).
This study was approved by Tokat Gaziosmanpasa University Institutional Review Board and Ethics Committee (Project no= 20-KAEK-311, Approval Date= 12/17/2020).
Pregnant women who are over 37 weeks, have no pregnancy complications, and will undergo uterine surgery for the first time will be included in the study. Exclusion criteria are determined as: Preoperative hemogram value below 10mg/dL, active labor (regular contraction and> 4cm cervical opening), placental anomaly, previous uterine surgery, chorioamnionitis, premature rupture of membranes, additional disease, body mass index BMI> 35kg / m2, consuming tobacco and / or alcohol, needing blood transfusion and multiple pregnancy.
Randomization will be created on a computer controlled by a statistician to create two groups. Before cesarean delivery, sealed, opaque and numbered envelope containing the definition and image of the suture technique will be reported to the surgeon. Participants included in the study 3 months after the operation will be called for control by an external observer. Follow-up data and ultrasound measurements of uterine incision scar area will be documented by sonographer who does not know the uterotomy closure technique applied to the patient.
During the follow up examination, weight and breastfeeding status of the patient and ultrasound measurement of uterine length, uterine position, residual myometrial thickness, isthmocele depth, isthmocele width, cervical thickness, isthmocele fundus distance, isthmocele cervical distance, hypoechoic isthmocele width in transverse plane will be recorded.
The sample size was calculated based on a study by Roberge S et al. (2016) titled Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. The mean residual myometrial thickness values of this study were found to be 3.8 ± 1.57 in the single-layered group and 4.77 ± 1.34 in the double-stitched group. The power analysis performed using GPower 3.1 (http://www.gpower.hhu.de/) program, when 80% power and alpha = 0.05 are taken, the total sample size calculated using the student's t test was found to be 36 for each group. Considering possible problems, it is planned to include 80 participants, 40 for each group. The normal distribution of the data of the measurements will be analyzed with the Kolmogorov-Smirnov test. The data of two groups of patients will be analyzed with the Statistical Package for Social Sciences (SPSS) version 20 program using one-way ANOVA analysis, post-hoc test, T-test, chi-square and Fisher test according to the data characteristics. Statistical significance will be accepted as p <0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tokat, Turkey, 60000
- Gaziosmanpasa University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women undergoing their first cesarean section
- After 37 gestational week pregnancy
- Have no pregnancy complications
Exclusion Criteria:
- Preoperative hemogram value below 10mg / dl
- Active labor (regular contraction and> 4cm cervical opening)
- Placental anomaly
- Previous uterine surgery
- Chorioamnionitis
- Premature rupture of membranes
- Additional disease will affect tissue healing
- Body mass index BMI> 35kg / m2
- Consuming tobacco and / or alcohol
- Needing blood transfusion
- Multiple pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Uterine closure with "Baseball" suture technique
Participants will undergo "Baseball" suture closure of the hysterotomy site at the time of cesarean section.
|
A simple running (continuous) "baseball" suture is essentially an interrupted sutures.
Applied as inside to outside/inside to outside of incision.
|
ACTIVE_COMPARATOR: Single Layer Continuous Locked
Participants will undergo Single Layer Continuous Locked suture closure of the hysterotomy site at the time of cesarean section.
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Suturing is continued by passing through the previous stitch.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of isthmocele
Time Frame: 3 months
|
The presence of an isthmocele (minimum 2 mm x 2 mm) identified on a transvaginal ultrasound 3 months after the cesarean section
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3 months
|
Measurement of residual myometrial thickness
Time Frame: 3 months
|
Measurement of residual myometrial thickness on a transvaginal ultrasound 3 months after the cesarean section
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional hemostatic sutures
Time Frame: Through the surgery completion, an average of 30 minutes
|
Number of additional hemostatic sutures placed in the uterus
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Through the surgery completion, an average of 30 minutes
|
Operation time
Time Frame: Through the surgery completion, an average of 30 minutes
|
Length of surgery from skin to delivery and delivery to skin closure (minutes)
|
Through the surgery completion, an average of 30 minutes
|
Changes in Hemoglobin
Time Frame: 24 hours
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Changes in Hemoglobin from pre-operative measurement to post-operative measurement
|
24 hours
|
Measurement of uterus
Time Frame: 3 months
|
Measurements of uterus on a transvaginal ultrasound 3 months after the cesarean section( Uterus Length, Uterine position, Isthmocele depth, Isthmocele width, Cervical thickness, Fundus isthmocele distance, Isthmocele cervix distance, Hypoechoic isthmocele width in transverse plane)
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GaziosmanpasaKHD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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