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

Republic of Turkey Ministry of Health

Status: Completed

Conditions: Cesarean Section; Complications; Placenta Accreta; Placenta Previa

Treatments: Procedure: Purse string closure technique; Procedure: Continuously locked closure technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01289262

21.01.2011-02 (02) (Other Identifier)

Kartal2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 2 patient groups

Purse string closure technique

Active Comparator group

Description:

Uterine Kerr incision will be closed with purse string suture.

Treatment:

Procedure: Purse string closure technique

Continuously locked closure technique

Active Comparator group

Description:

Uterine Kerr incision will be closed with continuously locked closure technique.

Treatment:

Procedure: Continuously locked closure technique