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| ID | Type | Description | Link |
|---|---|---|---|
| 21.01.2011-02 (02) | Other Identifier | Ethics committee ID number |
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Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.
In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.) In the first group of patients classical closure method of Kerr incision(double layered continuously locked suturing) will be used. In the second group of patients double layered purse string closure technique will be used.
Women will be followed for a subsequent pregnancy in the next average 6 years. If they become pregnant again they will be followed up during pregnancy for comparison of long-term effects of the two suture techniques. Patients will be followed especially from the aspects of placental anomalies. Presence of intra-abdominal adhesions, uterine dehiscence, placenta previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or complete rupture will be compared between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Purse string closure technique | Active Comparator | Uterine Kerr incision will be closed with purse string suture. |
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| Continuously locked closure technique | Active Comparator | Uterine Kerr incision will be closed with continuously locked closure technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purse string closure technique | Procedure | Uterine incision will be closed with purse string closure technique. |
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| Measure | Description | Time Frame |
|---|---|---|
| Placenta Previa | It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. | Subsequent pregnancy within next average 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Placenta Insertion Anomalies | It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. | Subsequent pregnancy within next average 6 years |
| Uterine Rupture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cem Turan | Health Institutes of Turkey ISTANBUL, TURKEY | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Institutes of Turkey ISTANBUL, TURKEY | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37925053 | Derived | Turan C. Long-term follow-up of purse-string double-layer closure (Turan technique) for repairing the uterine incision during cesarean delivery. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101212. doi: 10.1016/j.ajogmf.2023.101212. Epub 2023 Nov 2. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Purse String Closure Technique | Uterine Kerr incision will be closed with purse string suture. Purse string closure technique: Uterine incision will be closed with purse string closure technique. |
| FG001 | Continuously Locked Closure Technique |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Continuously locked closure technique | Procedure | Uterine incision will be closed with continuously locked closure technique |
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It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. |
| Subsequent pregnancy within next average 6 years |
| Intra-abdominal Adhesions | It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. | Up to average 6 years |
Uterine Kerr incision will be closed with continuously locked closure technique. Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Purse String Closure Technique | Uterine Kerr incision will be closed with purse string suture. Purse string closure technique: Uterine incision will be closed with purse string closure technique. |
| BG001 | Continuously Locked Closure Technique | Uterine Kerr incision will be closed with continuously locked closure technique. Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Placenta Previa | It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. | Eighteen of 51 patients in the study group (purse string) became pregnant. Of the 18 patients in the study group, pregnancy was terminated by cesarean section without low lying placenta, placenta previa marginalis and placenta previa totalis. Of the 65 patients in the control group, 23 became pregnant. Three of them developed low lying placenta, two developed placenta previa marginalis, and one developed placenta previa totalis. | Posted | Count of Participants | Participants | Subsequent pregnancy within next average 6 years |
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| Secondary | Placenta Insertion Anomalies | It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. | Placental adhesion (insertion) anomaly did not develop in any of the 18 cases who became pregnant in the Turan technique (purse string) group and in none of the 23 cases who became pregnant in the control (continuously locked closure) group. | Posted | Count of Participants | Participants | Subsequent pregnancy within next average 6 years |
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| Secondary | Uterine Rupture | It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. | Uterine rupture (incomplete or complete, dehiscence of uterine incision) did not develop in any of the 18 cases who became pregnant in the Turan technique (Purse string closure technique) group and in none of the 23 cases who became pregnant in the control (continuously locked closure technique) group. | Posted | Count of Participants | Participants | Subsequent pregnancy within next average 6 years |
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| Secondary | Intra-abdominal Adhesions | It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared. | Intra-abdominal filmy adhesion was detected in 2 of 18 pregnant cases in the Turan technique (purse string) group and intra-abdominal adhesion developed in 6 of 23 cases who became pregnant in the control (Continuously locked closure technique) group. Three of them were filmy and the other three were dense adhesions involving the omentum and intestine. | Posted | Count of Participants | Participants | Up to average 6 years |
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6 years
No Adverse event
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Purse String Closure Technique | Uterine Kerr incision will be closed with purse string suture. Purse string closure technique: Uterine incision will be closed with purse string closure technique. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | Continuously Locked Closure Technique | Uterine Kerr incision will be closed with continuously locked closure technique. Continuously locked closure technique: Uterine incision will be closed with continuously locked closure technique | 0 | 23 | 0 | 23 | 0 | 23 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR CEM TURAN | DrLutfiKirdarTRH | 00905323513423 | cemturan@gmail.com |
| ID | Term |
|---|---|
| D010923 | Placenta Previa |
| D010921 | Placenta Accreta |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010922 | Placenta Diseases |
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| Male |
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| Placenta previa marginalis |
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| Placenta previa totalis |
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