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

Assessment of Single and Double Layer Suturation of Lower Segment Uterine Incision by Ultrasonography After Cesarean Section

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03676907
Enrollment
56
Registered
2018-09-19
Start date
2018-03-15
Completion date
2023-07-15
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Scar

Keywords

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

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.

Detailed description

In our clinic, cesarean operation is performed with blunt and sharp dissections in the abdomen followed by transverse incision of the lower segment to the uterus. After uterotomy, the incision will be closed with single or double layer suture. The single layer suture technique will be performed with suturing by taking approximately 1 cm of tissue from the upper and lower segments where the mucosa and muscular layer are stitched together and locking them continuously at intervals of about 1 cm. On the first layer of the double layer suture technique, about 0.5 cm of tissue is taken from the upper and lower segments and the mucosa is closed by locking about 1 cm intervals. On the second layer, about 1 cm of tissue is taken from lower and upper segments of the muscle layer and both sides will be sutured with continue non-locking suture technique. The uterotomy incision will be closed with multifilament, synthetic, braided, suture that absorbable in about 60-90 days. In both groups prophylactic intramuscular 1 gr Cefazolin and 20 intravenous units of oxytocin will be administered intravenously. Randomization will be done according to the patient's ID numbers. Patients who have a single digit of the end of ID number will be closed with continuous locking with suture, and patients who have a single digit of the end of ID number will be closed with double suture. The suture technique used and the number of additional hemostatic sutures will be obtained from the operation note. In addition, demographic characteristics of the patients, duration of operation, hemoglobin changes within 24 hours post-operatively, infant birth weight, hospitalization time, estimated blood loss during surgery will be examined in the study. The estimated blood loss will be recorded from the level of the initial aspirator bag after the surgery. Enrolled patients will be called for control 6 months after surgery. It will be evaluated by a single obstetrician in a supine position under standard conditions, with empty bladder, with transvaginal ultrasonographic device. Measurements will be made when the endometrium, lower uterine segment and cervix are visible in the sagittal section of the uterus during transvaginal ultrasonography. Scar defect will define as a hypoechoic wedge-shaped image that causes discontinuity in the structure of the endometrium which extending downward from the anterior line to the serosa. The width and depth of the sagittal plane of the defect and the axial length of the axial plane will be measured. Ultimately, these measurements will be taken volumetrically.

Interventions

PROCEDUREdouble layer suturation technique

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

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Comparing defective volume of myometrium at the location of cesarean section scar in double layer suturation technique and single layer suturation techniqueOver 6 months period after cesarean sectionThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026