IsthmoceleNCT04734366
Effect of Baseball Suturing on Isthmocele and Residual Myometrial Thickness After Cesarean
A study testing Uterine closure with "Baseball" suture technique and Single Layer Continuous Locked in people with Isthmocele and Cesarean Section Complications, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Isthmocele, Cesarean Section Complications
- What is being tested?
- Uterine closure with "Baseball" suture technique and Single Layer Continuous Locked
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Dec 2020to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing their first cesarean section
- After 37 gestational week pregnancy
- Have no pregnancy complications
Who cannot join
- Preoperative hemogram value below 10mg / dl
- Active labor (regular contraction and> 4cm cervical opening)
- Placental anomaly
- Previous uterine surgery
- Chorioamnionitis
- Premature rupture of membranes
Show all 11Show fewer
- Additional disease will affect tissue healing
- Body mass index BMI> 35kg / m2
- Consuming tobacco and / or alcohol
- Needing blood transfusion
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60000
About this study
Official title: 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.
Read the 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.
- Conditions
- Isthmocele, Cesarean Section Complications
- Being tested
- Uterine closure with "Baseball" suture technique, Single Layer Continuous Locked
- Keywords
- isthmocele, baseball suture, cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine closure with "Baseball" suture techniqueProcedure or surgery
A simple running (continuous) "baseball" suture is essentially an interrupted sutures. Applied as inside to outside/inside to outside of incision.
Single Layer Continuous LockedProcedure or surgery
Suturing is continued by passing through the previous stitch.
| Study group | Role | What they receive |
|---|---|---|
| Uterine closure with "Baseball" suture technique | Experimental | Participants will undergo "Baseball" suture closure of the hysterotomy site at the time of cesarean section. Receives: Procedure: Uterine closure with "Baseball" suture technique |
| Single Layer Continuous Locked | Active comparator | Participants will undergo Single Layer Continuous Locked suture closure of the hysterotomy site at the time of cesarean section. Receives: Procedure: Single Layer Continuous Locked |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of isthmocele
The presence of an isthmocele (minimum 2 mm x 2 mm) identified on a transvaginal ultrasound 3 months after the cesarean section
Measured: 3 months
Measurement of residual myometrial thickness
Measurement of residual myometrial thickness on a transvaginal ultrasound 3 months after the cesarean section
Measured: 3 months
Secondary outcomes (4)
Additional hemostatic sutures
Number of additional hemostatic sutures placed in the uterus
Measured: Through the surgery completion, an average of 30 minutes
Operation time
Length of surgery from skin to delivery and delivery to skin closure (minutes)
Measured: Through the surgery completion, an average of 30 minutes
Changes in Hemoglobin
Changes in Hemoglobin from pre-operative measurement to post-operative measurement
Measured: 24 hours
Measurement of uterus
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start17 Dec 2020
- Primary completion30 Jun 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsthmoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlhan Bahri Delibas, Tokat Gaziosmanpasa University
- Investigators
- Ilhan B Delibasi, A. Prof., Principal investigator, Gaziosmanpasa University Obstetrics and Gynecology departmentKaan E Uzun, M.D., Study chair, Gaziosmanpasa University Obstetrics and Gynecology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734366
- Sponsor's protocol ID
- GaziosmanpasaKHD
- Status last verified
- Feb 2023
- First submitted
- 26 Dec 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Baseball Suturing Technique on the Incidence of Isthmocele and Residual Myometrial Thickness After Cesarean: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04734366
- Acronym / sponsor ID
- GaziosmanpasaKHD
- Conditions
- Isthmocele, Cesarean Section Complications
- Keywords
- isthmocele, baseball suture, cesarean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine closure with "Baseball" suture technique | Experimental | Procedure: Uterine closure with "Baseball" suture techniqueParticipants will undergo "Baseball" suture closure of the hysterotomy site at the time of cesarean section. |
| Single Layer Continuous Locked | Active comparator | Procedure: Single Layer Continuous LockedParticipants will undergo Single Layer Continuous Locked suture closure of the hysterotomy site at the time of cesarean section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women undergoing their first cesarean section
- After 37 gestational week pregnancy
- Have no pregnancy complications
Key exclusion criteria (11 listed)
- Preoperative hemogram value below 10mg / dl
- Active labor (regular contraction and> 4cm cervical opening)
- Placental anomaly
- Previous uterine surgery
- Chorioamnionitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine closure with "Baseball" suture techniqueA simple running (continuous) "baseball" suture is essentially an interrupted sutures. Applied as inside to outside/inside to outside of incision. | Procedure or surgery | Uterine closure with "Baseball" suture technique |
| Single Layer Continuous LockedSuturing is continued by passing through the previous stitch. | Procedure or surgery | Single Layer Continuous Locked |
Primary outcome
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
Measurement of residual myometrial thickness
Time frame: 3 months
Measurement of residual myometrial thickness on a transvaginal ultrasound 3 months after the cesarean section
4 secondary outcomes
Additional hemostatic sutures
Time frame: Through the surgery completion, an average of 30 minutes
Operation time
Time frame: Through the surgery completion, an average of 30 minutes
Changes in Hemoglobin
Time frame: 24 hours
Measurement of uterus
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilhan B Delibasi, A. Prof. principal investigator
Gaziosmanpasa University Obstetrics and Gynecology department
Kaan E Uzun, M.D. study chair
Gaziosmanpasa University Obstetrics and Gynecology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine closure with "Baseball" suture technique and Single Layer Continuous Locked in people with Isthmocele and Cesarean Section Complications, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of isthmocele (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.