Uterine Closure Techniques and Cesarean Scar Defect Risk

Cesarean Section Complications Clinical Trial

Official title:

Comparison of Uterine Closure Techniques During Cesarean Section With Respect to the Development of Cesarean Scar Defects a Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05100147
• Other study ID #: 473
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: October 2023
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cesarean operations are one of the most common obsetric operations and have an increasing trend in all over the world. However unfortunately the operation techniques have not been standardized yet. It is well known that different uterine closure techniques result in differences with respect to wound healing on the uterus; however, the ideal uterine closure technique is yet not known. The aim of this study is to assess the results of different uterine closure techniques during cesarean section with respect to the development of cesarean scar defects.

Description:

Patients were randomized into three groups using a computer-based program (ratio 1:1:1), and the assigned surgical technique was disclosed just before surgery. At the time of surgery, the sealed opaque envelope, numbered consecutively and containing the description of the suturation technique, was given to the operator. Suturing techniques varied between groups: double layer continuous, non-locking suturing with endometrial inclusion, second layer imbricating the first layer (Group 1), double layer, continuous, non-locking suturing without endometrial inclusion second layer imbricating the first layer (Group 2) and double layer continuous with the first layer unlocked, including the endometrium and the deep part of the myometrium, and the second layer continuous unlocked including the remaining part of the myometrium (Group 3) (Figure 2). Size 1 polyglycolic acid 910 (Vicryl ® Ethicon Inc. Somerville, NJ) was used as suture material in all groups.

Patients were re-evaluated at the sixth month as uterine scar healing is reported to be completed within six months and preoperative assessments were repeated. Transvaginal ultrasonography was performed by an investigator blinded to suturing techniques. Measurements included RMT, and CSD assessment (as the primary outcomes) (including the depth and width of the CSD), as well as other routine ultrasonographic evaluations. Transvaginal sonography was performed by the same investigator with a Toshiba Applio 500 device using a PMW-621VT 6 Mhz R13 probe. CSD was considered when myometrial continuity in the previous caesarean incision site was lost, and an anechoic defective area towards the myometrium was noted. In patients who did not develop CSD, the incision line was measured anteriorly, and the symmetrical posterior uterine wall thickness was measured. In patients with CSD, the myometrium tissue above the anechoic defective area was evaluated as residual myometrial thickness. The CSD sac's depth and its base's width were measured. The full-thickness myometrium adjacent to the defect area was measured, and recovery rates were calculated by taking the percentage of the residual myometrial thickness over the defect to the full-thickness myometrium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. being nulliparous

2. having singleton fetus

3. not having diabetes and or hypertension

4. not having an intrauterine infection

5. body mass index <35 kg/m2

6. not having any placental insertion anomalies

7. not having Mullerian anomalies

8. active phase of labor is not started.

9. no previous uterine surgeries

Exclusion Criteria:

1. being multiparous

2. having multiple pregnancies

3. having diabetes and or hypertension

4. having an intrauterine infection

5. body mass index >=35 kg/m2

6. having any placental insertion anomalies

7. having Mullerian anomalies

8. in active phase of labor

9. having previous uterine surgeries

Related Conditions & MeSH terms

• Cesarean Section Complications
• Congenital Abnormalities

Intervention

Procedure:
• Uterine closure during Cesarean section
The uterotomy is sutured after the delivery of the fetus and the placenta with an appropriate delayed absorbable suture (number 1 polyglactin 910)

Locations

Country	Name	City	State
Turkey	Mersin University Hospital	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar thickness at postpartum 6th week	The patients will be examined at the postpartum sixth week. During that visit uterine scar thickness will be measured by ultrasound. Measurement of uterine scar thickness will be performed perpendicular to the uterine wall and calipers will be placed on the serosal surface of the uterus and the delineation of the endometrium. These landmarks represent the inner and outer edge of the Cesarean scar.	Postpartum 6th weeks
Primary	Scar thickness at postpartum 6th month	The patients will be reexamined at the postpartum sixth month. During that visit uterine scar thickness will be measured again. Measurement of uterine scar thickness will be performed with the same method (perpendicular to the uterine wall and calipers will be placed on the serosal surface of the uterus and the delineation of the endometrium. These landmarks represent the inner and outer edge of the Cesarean scar.)	Postpartum 6th months