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

Placenta Accreta Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289262
• Other study ID #: Kartal2
• Secondary ID: 21.01.2011-02 (0
• Status: Completed
• Phase: N/A
• First received: February 2, 2011
• Last updated: January 20, 2016
• Start date: January 2011
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Dr.Lütfi Kirdar Kartal Egitim ve Arastirma Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section; Complications
• Placenta Accreta
• Placenta Previa

Intervention

Procedure:
• Purse string closure technique
Uterine incision will be closed with purse string closure technique.
• Continuously locked closure technique
Uterine incision will be closed with continuously locked closure technique

Locations

Country	Name	City	State
Turkey	Dr. Lütfi Kirdar Kartal Education and Research Hospital, Kartal	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Dr.Lütfi Kirdar Kartal Egitim ve Arastirma Hastanesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
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 4 years, and two groups will be compared.	Subsequent pregnancy within 4 years	No
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 4 years, and two groups will be compared.	Subsequent pregnancy within next 4 years	No
Secondary	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	No