Effect of Baseball Suturing on Isthmocele and Residual Myometrial Thickness After Cesarean

February 2, 2023 updated by: İlhan Bahri Delibas, Tokat Gaziosmanpasa University

Effect of the Baseball Suturing Technique on the Incidence of Isthmocele and Residual Myometrial Thickness After Cesarean: a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tokat, Turkey, 60000
        • Gaziosmanpasa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Uterine closure with "Baseball" suture technique
Participants will undergo "Baseball" suture closure of the hysterotomy site at the time of cesarean section.
Procedure: Uterine closure with "Baseball" suture technique
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.
Procedure: Single Layer Continuous Locked
Suturing is continued by passing through the previous stitch.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokat Gaziosmanpasa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GaziosmanpasaKHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

No end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data. Any purpose. Data was saved on Mendeley data but it will be published after the article publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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