Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03676907
Study type Interventional
Source Gazi University
Contact
Status Completed
Phase N/A
Start date March 15, 2018
Completion date July 15, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05096910 - Comparison Of Suture Materials on Sectio Scars (COSMOSS) N/A
Withdrawn NCT02968459 - Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars Phase 2
Withdrawn NCT03181087 - Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars Phase 1
Completed NCT03629028 - Single or Double-layer Uterine Closure Techniques N/A