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

NCT ID: NCT01289262

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2023-08-31

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.

Detailed 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 average 6 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.

Conditions

Cesarean Section; Complications; Placenta Previa; Placenta Accreta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Purse string closure technique

Uterine Kerr incision will be closed with purse string suture.

Group Type: ACTIVE_COMPARATOR

Purse string closure technique

Intervention Type: PROCEDURE

Uterine incision will be closed with purse string closure technique.

Continuously locked closure technique

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

Group Type: ACTIVE_COMPARATOR

Continuously locked closure technique

Intervention Type: PROCEDURE

Uterine incision will be closed with continuously locked closure technique

Interventions

Purse string closure technique

Uterine incision will be closed with purse string closure technique.

Intervention Type: PROCEDURE

Continuously locked closure technique

Uterine incision will be closed with continuously locked closure technique

Intervention Type: PROCEDURE

Other Intervention Names

Uterine incision in C/S; Uterine incision in C/S

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mehmet Cem Turan

Chief Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cem Turan

Role: STUDY_DIRECTOR

Health Institutes of Turkey ISTANBUL, TURKEY

Locations

Health Institutes of Turkey ISTANBUL, TURKEY

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 37925053 (View on PubMed)

Other Identifiers

21.01.2011-02 (02)

Identifier Type: OTHER

Identifier Source: secondary_id

Kartal2

Identifier Type: -

Identifier Source: org_study_id