Effect of Baseball Suturing on Isthmocele and Residual Myometrial Thickness After Cesarean

NCT04734366 | Completed

• 1 other identifier: GaziosmanpasaKHD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean delivery rates in Turkey as well as all over the world are increasing. Recent data in Turkey shows that the value of cesarean delivery rate reached 53%. This worldwide increase causes new concerns. Incomplete healing of the uterine scar after cesarean is a complication with potential long-term consequences. There is evidence that the risk of uterine scar defects is associated with the number of previous cesarean deliveries and the method of uterotomy closure. Study was designed as prospective randomized clinical trial to analyze the effects of two different uterine suture techniques. The investigators aim is to compare the closure of the incision with the "baseball" suture technique and the single-layer locking technique in terms of the incidence and depth of the isthmocele in the uterine incision scar as a short-term result.

Conditions

Isthmocele; Cesarean Section Complications

Keywords

isthmocele; baseball suture; cesarean

Outcome Measures

Primary Outcomes (2)

• Presence of isthmocele

  The presence of an isthmocele (minimum 2 mm x 2 mm) identified on a transvaginal ultrasound 3 months after the cesarean section

  3 months

• Measurement of residual myometrial thickness

  Measurement of residual myometrial thickness on a transvaginal ultrasound 3 months after the cesarean section

  3 months

Secondary Outcomes (4)

• Additional hemostatic sutures

  Through the surgery completion, an average of 30 minutes

• Operation time

  Through the surgery completion, an average of 30 minutes

• Changes in Hemoglobin

  24 hours

• Measurement of uterus

  3 months

Study Arms (2)

Uterine closure with "Baseball" suture technique

EXPERIMENTAL

Participants will undergo "Baseball" suture closure of the hysterotomy site at the time of cesarean section.

Procedure: Uterine closure with "Baseball" suture technique

Single Layer Continuous Locked

ACTIVE COMPARATOR

Participants will undergo Single Layer Continuous Locked suture closure of the hysterotomy site at the time of cesarean section.

Procedure: Single Layer Continuous Locked

Interventions

Uterine closure with "Baseball" suture technique PROCEDURE

A simple running (continuous) "baseball" suture is essentially an interrupted sutures. Applied as inside to outside/inside to outside of incision.

Uterine closure with "Baseball" suture technique

Single Layer Continuous Locked PROCEDURE

Suturing is continued by passing through the previous stitch.

Single Layer Continuous Locked

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since this is a study done at the time of cesarean section, only females are eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing their first cesarean section
• After 37 gestational week pregnancy
• Have no pregnancy complications

You may not qualify if:

• Preoperative hemogram value below 10mg / dl
• Active labor (regular contraction and\> 4cm cervical opening)
• Placental anomaly
• Previous uterine surgery
• Chorioamnionitis
• Premature rupture of membranes
• Additional disease will affect tissue healing
• Body mass index BMI\> 35kg / m2
• Consuming tobacco and / or alcohol
• Needing blood transfusion
• Multiple pregnancy

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60000, Turkey (Türkiye)

Location

Study Officials

• Ilhan B Delibasi, A. Prof.

  Gaziosmanpasa University Obstetrics and Gynecology department

  PRINCIPAL INVESTIGATOR

• Kaan E Uzun, M.D.

  Gaziosmanpasa University Obstetrics and Gynecology department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tokat Gaziosmanpasa University, Head of Gynecology and Obstetrics Department

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: February 2, 2021
• Study Start: December 17, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 15, 2021
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: No end date.
• Access Criteria: Anyone who wishes to access the data. Any purpose. Data was saved on Mendeley data but it will be published after the article publication.

Locations

TU (1)