Evaluation of Cesarean Scar After Three Different Uterine Closure Technis

Cesarean Section, Repeated Clinical Trial

Official title:

Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915847
• Other study ID #: ATA35
• Status: Completed
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: April 16, 2020

Study information

• Verified date: May 2020
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated by transvaginal ultrasound six months after cesarean.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Previous two or three cesarean

• Gestational weeks >=36 weeks

Exclusion Criteria:

• Risk of obstetric haemorrhage

• Suspicion or diagnosis placenta previa or accrete syndrome

• Chorioamnionitis

• Uterine myoma in the anterior uterine segment

• Hysterotomy other than lower segment uterine incision at previous cesarean

Related Conditions & MeSH terms

• Cesarean Section, Repeated
• Cesarean, Residual Myometrial Thickness
• Cesarean, Uterine Scar Thickness
• Cicatrix

Intervention

Procedure:
• Single layer closure
Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.
• Double layer closure
The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
• Doble layer closure with trimming
Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.

Locations

Country	Name	City	State
Turkey	Ataturk University Hospital	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual myometrial thickness	Myometrial thickness at the uterine scar by transvaginal ultrasound	6 months after cesarean
Secondary	Existence of cesarean scar defect	The presence or absence of a cesarean scar defect that was defined as any unechogenic area visualised by transvaginal ultrasound at the site of the cesarean scar with a depth of at least 2 mm.	6 months after cesarean
Secondary	Width of defect	In a sagittal plane, the width at base of defect	6 months after cesarean
Secondary	Depth of defect (niche)	In a sagittal plane, the distance from the base lining of the endometrium to the apex	6 months after cesarean
Secondary	Operation time	Skin-to-skin operation time	10 minute after cesarean completed
Secondary	Change in hemoglobin	Difference in haemoglobin measured preoperatively and postoperatively 48 hours	48 hours after cesarean
Secondary	Blood product transfusion	Unite number of transfused packed erythrocyte	One week after cesarean
Secondary	Maternal infectious morbidity	Prevalence of postpartum endometritis, skin wound dehiscence and post operative fever.	Six weeks after cesarean
Secondary	Length of hospitalization	Duration in days	One month after cesarean