2 Arms, Conventional Suture, Barbed Suture Clinical Trial
Official title:
Deficient Lower Segment Cesarean Section Scar, Does the Type of Suture Matter?
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
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