NCT01289262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 19, 2024

Completed
Last Updated

August 19, 2024

Status Verified

March 1, 2024

Enrollment Period

6 years

First QC Date

February 2, 2011

Results QC Date

September 4, 2023

Last Update Submit

March 23, 2024

Conditions

Cesarean Section; ComplicationsPlacenta PreviaPlacenta Accreta

Keywords

Cesarean sectionKerr incisionPurse string suturing in CSContinuous locked suturing in CS

Outcome Measures

Primary Outcomes (1)

  • Placenta Previa

    It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.

    Subsequent pregnancy within next average 6 years

Secondary Outcomes (3)

  • Placenta Insertion Anomalies

    Subsequent pregnancy within next average 6 years

  • Uterine Rupture

    Subsequent pregnancy within next average 6 years

  • Intra-abdominal Adhesions

    Up to average 6 years

Study Arms (2)

Purse string closure technique

ACTIVE COMPARATOR

Uterine Kerr incision will be closed with purse string suture.

Procedure: Purse string closure technique

Continuously locked closure technique

ACTIVE COMPARATOR

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

Procedure: Continuously locked closure technique

Interventions

Purse string closure techniquePROCEDURE

Uterine incision will be closed with purse string closure technique.

Also known as: Uterine incision in C/S
Purse string closure technique
Continuously locked closure techniquePROCEDURE

Uterine incision will be closed with continuously locked closure technique

Also known as: Uterine incision in C/S
Continuously locked closure technique

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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 CS
  • Extension of Kerr incision
  • Multiple pregnancy
  • Maternal diabetes mellitus
  • Maternal connective tissue disease
  • Uterine malformation
  • Uterine fibroids on Kerr incision line
  • Chorioamnionitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Institutes of Turkey ISTANBUL, TURKEY

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Turan C. Long-term follow-up of purse-string double-layer closure (Turan technique) for repairing the uterine incision during cesarean delivery. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101212. doi: 10.1016/j.ajogmf.2023.101212. Epub 2023 Nov 2. No abstract available.

    PMID: 37925053DERIVED

MeSH Terms

Conditions

Placenta PreviaPlacenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Results Point of Contact

Title
DR CEM TURAN
Organization
DrLutfiKirdarTRH
cemturan@gmail.com
00905323513423

Study Officials

  • Cem Turan

    Health Institutes of Turkey ISTANBUL, TURKEY

    STUDY DIRECTOR

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

February 2, 2011

First Posted

February 3, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2017

Study Completion

August 1, 2023

Last Updated

August 19, 2024

Results First Posted

August 19, 2024

Record last verified: 2024-03

Locations

TU(1)