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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03649256
Other study ID # ZIV-0085-18
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2020
Est. completion date April 2021

Study information

Verified date January 2020
Source Ziv Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 202
Est. completion date April 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Post Cesarean section

Exclusion Criteria:

- Non low- transverse incision, after myomectomy, pregnancy

Study Design


Related Conditions & MeSH terms

  • 2 Arms, Conventional Suture, Barbed Suture

Intervention

Diagnostic Test:
Thickness of lower uterine segment scar
Ultrasound measurement of thickness of the uterine scar at 3 and 6 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ziv Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Uterine Thickness uterine myometrial thickness as measured by ultrasound 6 months
Secondary Uterine Thickness uterine myometrial thickness as measured by ultrasound 3 months