Clinical trial NCT03676907: Assessment of Single and Double Layer Suturation of Lower Segment Uterine Incision by USG After C/S
Official title: Assessment of Single and Double Layer Suturation of Lower Segment Uterine Incision by Ultrasonography After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Scar
Keywords: cesarean scar defect
single suturation technique
double suturation technique
myometrial thickness
uterine scar
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparing defective volume of myometrium at the location of cesarean section scar in double layer suturation technique and single layer suturation technique
timeFrame: Over 6 months period after cesarean section
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine
Study officials:
affiliation: Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi
name: Erhan DEMİRDAĞ, MD. Academic
role: STUDY_DIRECTOR
affiliation: Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi
name: Anıl Doğukan Tutal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi
name: Recep Onur Karabacak, MD. Academic
role: STUDY_CHAIR
References:
citation: 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.