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

NCT ID: NCT03676907

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2023-07-15

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.

Conditions

Uterine Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

single layer suturation technique

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

double layer suturation technique

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

Group Type: EXPERIMENTAL

double layer suturation technique

Intervention Type: 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

Interventions

double 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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Erhan Demirdag

Academic, Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erhan DEMİRDAĞ, MD. Academic

Role: STUDY_DIRECTOR

Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi

Anıl Doğukan Tutal, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi

Recep Onur Karabacak, MD. Academic

Role: STUDY_CHAIR

Ankara Gazi Üniversitesi Tıp Fakültesi Hastanesi

Locations

Gazi University Faculty of Medicine

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 18484679 (View on PubMed)

Other Identifiers

237

Identifier Type: -

Identifier Source: org_study_id