Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04734366
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2020-12-26
Brief Title:
Effect of Baseball Suturing on Isthmocele and Residual Myometrial Thickness After Cesarean
Sponsor:
Tokat Gaziosmanpasa University
Organization:
Tokat Gaziosmanpasa University
Study Overview
Official Title:
Effect of the Baseball Suturing Technique on the Incidence of Isthmocele and Residual Myometrial Thickness After Cesarean a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-02
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:
Cesarean delivery rates in Turkey as well as all over the world are increasing Recent data in Turkey shows that the value of cesarean delivery rate reached 53 This worldwide increase causes new concerns Incomplete healing of the uterine scar after cesarean is a complication with potential long-term consequences There is evidence that the risk of uterine scar defects is associated with the number of previous cesarean deliveries and the method of uterotomy closure Study was designed as prospective randomized clinical trial to analyze the effects of two different uterine suture techniques The investigators aim is to compare the closure of the incision with the baseball suture technique and the single-layer locking technique in terms of the incidence and depth of the isthmocele in the uterine incision scar as a short-term result
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 ie 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 12172020
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 10mgdL 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 38 157 in the single-layered group and 477 134 in the double-stitched group The power analysis performed using GPower 31 httpwwwgpowerhhude program when 80 power and alpha 005 are taken the total sample size calculated using the students 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 005
This study was approved by Tokat Gaziosmanpasa University Institutional Review Board and Ethics Committee Project no 20-KAEK-311 Approval Date 12172020
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 10mgdL 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 38 157 in the single-layered group and 477 134 in the double-stitched group The power analysis performed using GPower 31 httpwwwgpowerhhude program when 80 power and alpha 005 are taken the total sample size calculated using the students 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 005
Study Oversight
Has Oversight DMC:
None
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?:
None