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NCT Number: NCT01287611

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

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.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Lütfi Kirdar Kartal Education and Research Hospital

Istanbul, Kartal, 34050, Turkey (Türkiye)

About this study

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. The two groups will be compared after 6 weeks in terms of healing, operation time, blood loss, incision size and incisional scar defect( if present). A physician who does not know the method of closure will evaluate incision size by transabdominal and/or transvaginal ultrasound. The length of the incision and myometrial thickness in Kerr incisional line will be measured and recorded in longitudinal and transverse axis separately. If any incisional scar defect is determined it will be measured and recorded also.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 C/S
  • Extension of Kerr incision
  • Multiple pregnancy
  • Maternal diabetes mellitus
  • Maternal connective tissue disease
  • Uterine malformation
  • Uterine fibroids on Kerr incision line
  • Chorioamnionitis

Treatment and study plan

Purse string closure technique

Procedure

Uterine Kerr incision will be closed with purse string suture

Other names: Uterine incision in C/S

Continuously locked closure technique

Procedure

Uterine Kerr incision will be closed with continuously locked suturing

Other names: Uterine incision in C/S

Primary outcomes

  1. Cesarean Scar Defect in the Uterine Incisional Line

    Time frame: 6 weeks after C/S

    A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.

Secondary outcomes

  1. Length of Uterine Incision After Suturing

    Time frame: 6 weeks after C/S

    Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

Short 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2011
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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