Suture of UTerus and Ultrasound Repair Evaluation

Uterine Scar Defect Clinical Trial

— SUTURE  

Official title:

Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860859
• Other study ID #: C12-03-204
• Status: Completed
• Phase: N/A
• First received: May 9, 2013
• Last updated: May 14, 2015
• Start date: March 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This study compares three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3) double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned cesarean

• Primary cesarean

• = 38 gestational weeks

Exclusion Criteria:

• Previous cesarean

• Women < 18 years old

• Multiple gestation

• Mullerian anomalies

• Active labor

• Diabetes

• BMI >35 kg/m2

• Placenta praevia

• Chronic systemic disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Uterine Scar Defect

Intervention

Procedure:
• Closure of the hysterotomy at the time of primary cesarean

Locations

Country	Name	City	State
Canada	CHU de Québec	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	Laval University, Université de Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Roberge S, Boutin A, Chaillet N, Moore L, Jastrow N, Demers S, Bujold E. Systematic review of cesarean scar assessment in the nonpregnant state: imaging techniques and uterine scar defect. Am J Perinatol. 2012 Jun;29(6):465-71. doi: 10.1055/s-0032-1304829. Epub 2012 Mar 7. Review. — View Citation

Roberge S, Chaillet N, Boutin A, Moore L, Jastrow N, Brassard N, Gauthier RJ, Hudic I, Shipp TD, Weimar CH, Fatusic Z, Demers S, Bujold E. Single- versus double-layer closure of the hysterotomy incision during cesarean delivery and risk of uterine rupture. Int J Gynaecol Obstet. 2011 Oct;115(1):5-10. doi: 10.1016/j.ijgo.2011.04.013. Epub 2011 Jul 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean myometrium thickness	Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure.	6 months after intervention	No
Secondary	Estimated blood loss		Same day of intervention: day 1	No
Secondary	Operative time		Same day of intervention: day 1	No
Secondary	Mean number of haemostatic sutures		Same day of intervention: day 1	No