Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure

Study Overview
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Brief Summary
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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.

Detailed Description
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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 4 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.

Official Title
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Long Term Comparison of Double Layer Continuously Locked Closure of Uterine Incision in Cesarean Section Versus Double Layer Purse String Closure (Turan Technique): A Prospective Randomized Study

Conditions
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Cesarean Section; Complications, Placenta Previa, Placenta Accreta

Intervention / Treatment
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* Procedure: Purse string closure technique
* Procedure: Continuously locked closure technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy Term (> 37 weeks) pregnancy Cervical dilatation < 4 cm Kerr incision Age > 18 years old Exclusion Criteria: Being in active phase of labor Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa ) Having a history of uterine surgery (myomectomy, hysterotomy) other than CS Extension of Kerr incision Multiple pregnancy Maternal diabetes mellitus Maternal connective tissue disease Uterine malformation Uterine fibroids on Kerr incision line Chorioamnionitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Purse string closure technique<br>Uterine Kerr incision will be closed with purse string suture. | Procedure: Purse string closure technique<br>* Uterine incision will be closed with purse string closure technique.<br>* Other names: Uterine incision in C/S;|
| Active Comparator: Continuously locked closure technique<br>Uterine Kerr incision will be closed with continuously locked closure technique. | Procedure: Continuously locked closure technique<br>* Uterine incision will be closed with continuously locked closure technique<br>* Other names: Uterine incision in C/S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placenta previa | It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared. | Subsequent pregnancy within next 4 years | 

Secondary Outcome Measures

| Outcome Measure | 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 4 years, and two groups will be compared. | Subsequent pregnancy within 4 years | 
| 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 4 years, and two groups will be compared. | Subsequent pregnancy within next 4 years | 
| Intra-abdominal adhesions | It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared. | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Kerr incision, Purse string suturing in CS, Continuous locked suturing in CS