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

• Sponsor: Ataturk University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03644433
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.2
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section, Repeated; Cesarean, Uterine Scar Thickness; Cesarean, Residual Myometrial Thickness; Cesarean Section Complications; Cesarean Section; Complications, Wound, Dehiscence	Procedure: Single layer closure; Procedure: Double layer closure after resection uterine scar	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of Single Layer Versus Double Layer Uterine Closure on the Cesarean Scar Healing
• Actual Study Start Date: Aug 23, 2018
• Anticipated Primary Completion Date: Apr 30, 2019
• Anticipated Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Single layer Single layer closure	Procedure: Single layer closure; Uterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges.
Active Comparator: Double layer with resection Double layer closure after resection uterine scar	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. residual myometrial thickness [6 months after cesarean]

   Myometrial thickness at the uterine scar by transvaginal ultrasound

Secondary Outcome Measures

1. residual myometrial thickness [6 weeks after cesarean]

   Myometrial thickness at the uterine scar by transvaginal ultrasound

2. Healing ratio [6 months after cesarean]

   residual myometrial thickness * 100 /total myometrial thickness above uterine scar

3. Healing ratio [6 weeks after cesarean]

   residual myometrial thickness * 100 /total myometrial thickness above uterine scar

4. Existence of cesarean scar defect [6 months after cesarean]

   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.

5. Existence of cesarean scar defect [6 weeks after cesarean]

   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. Operation time [10 minute after cesarean completed]

   skin-to-skin operation time

7. Change in hemoglobin [48 hours after cesarean]

   Difference in haemoglobin measured preoperatively and postoperatively 48 hours

8. Blood product transfusion [One week after cesarean]

   unite number of transfused packed erythrocyte

9. Maternal infectious morbidity [six weeks after cesarean]

   prevalence of postpartum endometritis, skin wound dehiscence and post operative fever.

10. Length of hospitalization [One month after cesarean]

    Duration in days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atatürk Üniversitesi araştırma Hastanesi	Erzurum		Turkey	25240

Sponsors and Collaborators

• Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ragıp Atakan Al, Professor in obstetrics And gynecology, Ataturk University
• ClinicalTrials.gov Identifier: NCT03644433
• Other Study ID Numbers: B.30.2.ATA.0.01.00/4
• First Posted: Aug 23, 2018
• Last Update Posted: Aug 24, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 24, 2018