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

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ClinicalTrials.gov Identifier: NCT03649256
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
David Peleg, Ziv Hospital

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


Condition or disease Intervention/treatment
2 Arms, Conventional Suture, Barbed Suture Diagnostic Test: Thickness of lower uterine segment scar

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 202 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Deficient Lower Segment Cesarean Section Scar, Does the Type of Suture Matter?
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Conventional suture
closure of uterine incision with conventional suture (Vicryl, Ethicon)
Diagnostic Test: Thickness of lower uterine segment scar
Ultrasound measurement of thickness of the uterine scar at 3 and 6 months

Barbed suture
closure of uterine incision with barbed suture (Stratafix, Ethicon)
Diagnostic Test: Thickness of lower uterine segment scar
Ultrasound measurement of thickness of the uterine scar at 3 and 6 months




Primary Outcome Measures :
  1. Uterine Thickness [ Time Frame: 6 months ]
    uterine myometrial thickness as measured by ultrasound


Secondary Outcome Measures :
  1. Uterine Thickness [ Time Frame: 3 months ]
    uterine myometrial thickness as measured by ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
status post cesarean section
Criteria

Inclusion Criteria:

  • Post Cesarean section

Exclusion Criteria:

  • Non low- transverse incision, after myomectomy, pregnancy

Additional Information:

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Responsible Party: David Peleg, Staff physician, Ziv Hospital
ClinicalTrials.gov Identifier: NCT03649256    
Other Study ID Numbers: ZIV-0085-18
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by David Peleg, Ziv Hospital:
conventional suture, barbed suture, niche, scar, cesarean section