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

NCT01287611 | Completed Results DMC

• 2 other identifiers: Kartal121.01.2011-02(1)
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

Cesarean section; Kerr incision; Purse string suturing in C/S; Continuous locked suturing in C/S

Outcome Measures

Primary Outcomes (1)

• Cesarean Scar Defect in the Uterine Incisional Line

  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.

  6 weeks after C/S

Secondary Outcomes (1)

• Length of Uterine Incision After Suturing

  6 weeks after C/S

Study Arms (2)

Purse string closure technique

ACTIVE COMPARATOR

Eighty four patients were allocated to the study group. Due to expanded Kerr incisions 4 patients in study group did not receive their allocated intervention. In addition, 29 patients in the study group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 51 study group.

Procedure: Purse string closure technique

Continuously locked closure technique

ACTIVE COMPARATOR

Eighty four patients were allocated to the control group. Due to expanded Kerr incisions 3 patients in control group did not receive their allocated intervention. In addition, 16 patients in the control group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 65 study group.

Procedure: Continuously locked closure technique

Interventions

Purse string closure technique PROCEDURE

Uterine Kerr incision will be closed with purse string suture

Also known as: Uterine incision in C/S

Purse string closure technique

Continuously locked closure technique PROCEDURE

Uterine Kerr incision will be closed with continuously locked suturing

Also known as: Uterine incision in C/S

Continuously locked closure technique

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• Term (\> 37 weeks) pregnancy
• Cervical dilatation \< 4 cm
• Kerr incision
• Age \> 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Dr. Lütfi Kirdar Kartal Education and Research Hospital

Istanbul, Kartal, 34050, Turkey (Türkiye)

Location

Related Publications (1)

• Turan C, Buyukbayrak EE, Yilmaz AO, Karsidag YK, Pirimoglu M. Purse-string double-layer closure: a novel technique for repairing the uterine incision during cesarean section. J Obstet Gynaecol Res. 2015 Apr;41(4):565-74. doi: 10.1111/jog.12593. Epub 2014 Nov 5.

  PMID: 25370526 BACKGROUND

Related Links

• Pubmed
• The video of purse string uterine closure (Turan Technique) in cesarean section

Limitations and Caveats

The present trial is a single-center study. The similar results should be supported in a multicenter study. Another limitation of this study is the more than 25% overall rate of loss to follow-up.

Results Point of Contact

• Title: Dr. Cem Turan
• Organization: DrLutfi

cemturan@gmail.com

00905323513423

Study Officials

• Yasemin Karsidağ

  Dr. Lutfi Kirdar Kartal Education and Research Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Clinical

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 1, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 28, 2023
• Results First Posted: August 29, 2014

Record last verified: 2023-09

Locations

TU (1)