Deficient Lower Segment Cesarean Section Scar, Does the Type of Suture Matter?

NCT03649256 | Unknown FDA Device

• 1 other identifier: ZIV-0085-18
• Study Type: observational
• Target: 202
• Locations: 0 countries
• Sites: N/A

Brief Summary

In recent years there has been a significant increase in cesarean sections. This is not without complication in subsequent pregnancies such as placenta previa, placenta accrete, scar pregnancy, dehiscence or uterine rupture. Uterine rupture during trial of labor after cesarean section is an uncommon but potentially catastrophic, life threatening event. It is thus of importance if the investigators were able to predict the risk of uterine rupture. Imaging studies including ultrasound, hysterography and sonohysterography have been used to evaluate the scar from a prior cesarean before pregnancy, there is no consensus as to which of them is the preferred method but it is known that cesarean section scars can be detected reliably by ultrasound imaging. Previous studies have shown that sonographic lower uterine segment thickness is a strong predictor for uterine scar defect and could represent a high risk of uterine rupture during a trial of labor in women with prior cesarean section. There is a likely association between large defects in the scar after cesarean delivery detected by transvaginal ultrasonography in non pregnant women and uterine rupture or dehiscence in subsequent pregnancy. The knotless barbed suture was FDA approved in 2004. Knotless barbed sutures are monofilament sutures with barbs cut into them. These sutures self-anchor, maintaining tissue approximation without the need for surgical knots. The objective of this study is to determine whether there is a difference in the lower uterine segment thickness between uterine scars sutured with two types of sutures, to determine whether there is a difference in the size of the scar defects. Methods: Two hundred and two women will undergo transvaginal ultrasound examination 3 and 6 months after delivery: 101 women will have undergone cesarean section in which the Vicryl suture was used, 101 women will have undergone cesarean section in which the KBS suture was used. The ultrasound examiner will be blinded to the use of the suture. The investigators will measure the myometrial thickness 3 months and 6 months after the delivery and compare the results between the 2 groups. The assumption is that the findings of the study will be useful in counseling concerning Trial of Labor after Cesarean (TOLAC). To the best of the investigators' knowledge, there are no published data on the risk of uterine rupture predicted based on the myometrial thickness measured in the non-pregnant patient when the knotless barbed suture was used in the cesarean section. Previous studies have examined the applicability of low uterine segment measurement in the third trimester in the prediction of a uterine defect during trial of labor

Conditions

2 Arms, Conventional Suture, Barbed Suture

Keywords

conventional suture, barbed suture, niche, scar, cesarean section

Outcome Measures

Primary Outcomes (1)

• Uterine Thickness

  uterine myometrial thickness as measured by ultrasound

  6 months

Secondary Outcomes (1)

• Uterine Thickness

  3 months

Study Arms (2)

Conventional suture

closure of uterine incision with conventional suture (Vicryl, Ethicon)

Diagnostic Test: Thickness of lower uterine segment scar

Barbed suture

closure of uterine incision with barbed suture (Stratafix, Ethicon)

Diagnostic Test: Thickness of lower uterine segment scar

Interventions

Thickness of lower uterine segment scar DIAGNOSTIC_TEST

Ultrasound measurement of thickness of the uterine scar at 3 and 6 months

Barbed suture; Conventional suture

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

status post cesarean section

You may qualify if:

• Post Cesarean section

You may not qualify if:

• Non low- transverse incision, after myomectomy, pregnancy

Sponsors & Collaborators

• Ziv Hospital: lead

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 28, 2018
• Study Start: April 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: April 1, 2021
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share