Clinical trial NCT01289262: Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Complications
Placenta Previa
Placenta Accreta
Keywords: Cesarean section
Kerr incision
Purse string suturing in CS
Continuous locked suturing in CS
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2011-02-03
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Placenta Previa
timeFrame: Subsequent pregnancy within next average 6 years
Secondary outcomes:
measure: Placenta Insertion Anomalies
timeFrame: Subsequent pregnancy within next average 6 years
measure: Uterine Rupture
timeFrame: Subsequent pregnancy within next average 6 years
measure: Intra-abdominal Adhesions
timeFrame: Up to average 6 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Health Institutes of Turkey ISTANBUL, TURKEY
Study officials:
affiliation: Health Institutes of Turkey ISTANBUL, TURKEY
name: Cem Turan
role: STUDY_DIRECTOR
References: