Impact of Uterine Closure Techniques on the Cesarean Scar Thickness After Repeated Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

Impact of Single Layer Versus Double Layer Uterine Closure on the Cesarean Scar Healing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03644433
• Other study ID #: B.30.2.ATA.0.01.00/4
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: August 2018
• Source: Ataturk University
• Contact: Rasit Özler, Md
• Phone: 00905465252595
• Email: m.rasitozler[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness by transvaginal ultrasound six months after cesarean.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• 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 Complications
• Cesarean Section, Repeated
• Cesarean Section; Complications, Wound, Dehiscence
• Cesarean, Residual Myometrial Thickness
• Cesarean, Uterine Scar Thickness

Intervention

Procedure:
• Single layer closure
Uterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges.
• Double layer closure after resection uterine scar
Uterine incision will be trimmed and old scar tissue will be removed. Then first, endometrium will be approximated by continuous unlocked suture mimicking subcuticular suture avoiding the inclusion of endometrium and second, upper part of myometrium will be approximated by a continuous unlocked suture.

Locations

Country	Name	City	State
Turkey	Atatürk Üniversitesi arastirma Hastanesi	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	residual myometrial thickness	Myometrial thickness at the uterine scar by transvaginal ultrasound	6 weeks after cesarean
Secondary	Healing ratio	residual myometrial thickness * 100 /total myometrial thickness above uterine scar	6 months after cesarean
Secondary	Healing ratio	residual myometrial thickness * 100 /total myometrial thickness above uterine scar	6 weeks 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 1 mm.	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 1 mm.	6 weeks 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