Assessment of Single and Double Layer Suturation of Lower Segment Uterine Incision by USG After C/S

NCT03676907 | Completed DMC

• 1 other identifier: 237
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

After 6 months of cesarean delivery, the investigators will compare uterine incision scar defects of single and double layer suturation of uterine incision by transvaginal ultrasonography.

Conditions

Uterine Scar

Keywords

cesarean scar defect; single suturation technique; double suturation technique; myometrial thickness; uterine scar

Outcome Measures

Primary Outcomes (1)

• Comparing defective volume of myometrium at the location of cesarean section scar in double layer suturation technique and single layer suturation technique

  The volume measurement will be obtained ultrasonographically as a result of the width and depth measured on the sagittal plane of the defect as described by the formula of π x 4/3 multiplied by the length which will be imaged on the axial section of the uterus. The length of myometrial tissue that extends perpendicularly from the lower end of the scar defect to the serosa, ie the distance between the inner and outer edges of the cesarean scar, will be assessed and measured as the residual myometrial thickness.

  Over 6 months period after cesarean section

Study Arms (2)

single layer suturation technique

NO INTERVENTION

in this arm we use single layer suturation technique to suture uterine incision

double layer suturation technique

EXPERIMENTAL

in this arm we use double layer suturation technique to suture uterine incision

Procedure: double layer suturation technique

Interventions

double layer suturation technique PROCEDURE

in our clinic uterine incision is sutured by single layer suturation technique routinely. in this arm, we will use double layer suturation technique which is also accepted as valid suturation technique in obstetrics and gynecology textbooks

double layer suturation technique

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those who are agreeing to participate in the study
• Planned or elective caesarean section
• The term singular pregnancies between 37 weeks 0/7 days - 41weeks 6/7 days of gestation that will be delivered on cesarean section without emergency conditions will be included in the study.

You may not qualify if:

• Not accepting to participate in the work
• Emergency cesarean
• Multiple pregnancy
• Diabetic patients
• Past uterine surgery
• Uterine malformation
• The infectious process (local, uterine or systemic)
• If surgeon needs additional two more hemostatic suturation during cesarean section.
• Women with connective tissue disease will not be included in the study.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Raine-Fenning N, Jayaprakasan K, Clewes J, Joergner I, Bonaki SD, Chamberlain S, Devlin L, Priddle H, Johnson I. SonoAVC: a novel method of automatic volume calculation. Ultrasound Obstet Gynecol. 2008 Jun;31(6):691-6. doi: 10.1002/uog.5359.

  PMID: 18484679 BACKGROUND

Study Officials

• Erhan DEMİRDAĞ, MD. Academic

  Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi

  STUDY DIRECTOR

• Anıl Doğukan Tutal, MD

  Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi

  PRINCIPAL INVESTIGATOR

• Recep Onur Karabacak, MD. Academic

  Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic, Director

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 19, 2018
• Study Start: March 15, 2018
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

TU (1)