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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mehmet Cem Turan, Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
ClinicalTrials.gov Identifier:
NCT01289262
First received: February 2, 2011
Last updated: April 29, 2012
Last verified: March 2012

February 2, 2011
April 29, 2012
January 2011
May 2015   (final data collection date for primary outcome measure)
Placenta previa [ Time Frame: Subsequent pregnancy within next 4 years ] [ Designated as safety issue: No ]
It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next 4 years, and two groups will be compared.
Same as current
Complete list of historical versions of study NCT01289262 on ClinicalTrials.gov Archive Site
  • Placenta insertion anomalies [ Time Frame: Subsequent pregnancy within 4 years ] [ Designated as safety issue: No ]
    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.
  • Uterine rupture [ Time Frame: Subsequent pregnancy within next 4 years ] [ Designated as safety issue: No ]
    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.
  • Intra-abdominal adhesions [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cesarean Section; Complications
  • Placenta Previa
  • Placenta Accreta
  • Procedure: Purse string closure technique
    Uterine incision will be closed with purse string closure technique.
    Other Name: Uterine incision in C/S
  • Procedure: Continuously locked closure technique
    Uterine incision will be closed with continuously locked closure technique
    Other Name: Uterine incision in C/S
  • Active Comparator: Purse string closure technique
    Uterine Kerr incision will be closed with purse string suture.
    Intervention: Procedure: Purse string closure technique
  • Active Comparator: Continuously locked closure technique
    Uterine Kerr incision will be closed with continuously locked closure technique.
    Intervention: Procedure: Continuously locked closure technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
August 2015
May 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01289262
Kartal2, 21.01.2011-02 (02)
Yes
Mehmet Cem Turan, Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
Not Provided
Study Chair: Yasemin Karsidag Dr. Lutfi Kirdar Kartal Education and Research Hospital
Dr.Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP