Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
- Conditions
- Placenta AccretaCesarean Section; ComplicationsPlacenta Previa
- Interventions
- Procedure: Purse string closure techniqueProcedure: Continuously locked closure technique
- Registration Number
- NCT01289262
- Lead Sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 168
- Singleton pregnancy
- Term (> 37 weeks) pregnancy
- Cervical dilatation < 4 cm
- Kerr incision
- Age > 18 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Purse string closure technique Purse string closure technique Uterine Kerr incision will be closed with purse string suture. Continuously locked closure technique Continuously locked closure technique Uterine Kerr incision will be closed with continuously locked closure technique.
- Primary Outcome Measures
Name Time Method Placenta Previa Subsequent pregnancy within next average 6 years 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.
- Secondary Outcome Measures
Name Time Method Placenta Insertion Anomalies Subsequent pregnancy within next average 6 years 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.
Intra-abdominal Adhesions Up to average 6 years 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.
Uterine Rupture Subsequent pregnancy within next average 6 years 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.
Trial Locations
- Locations (1)
Health Institutes of Turkey ISTANBUL, TURKEY
🇹🇷Istanbul, Turkey