Cesarean Section Clinical Trial
Official title:
Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency: A Randomized Controlled Trial
In recent decades, the rate of cesarean section delivery has steadily increased worldwide
ranging at 30% of deliveries, thus long-term risks after cesarean section need to be
evaluated. Postoperative risks include, among others, uterine scar rupture and placental
complications such as placenta previa and accreta- complications, which are possibly
associated with uterine scar dehiscence.
The prevalence of lower-segment uterine scar deficiency has previously been described as 63%.
One recent systematic review and meta analysis investigated closure techniques of low
transverse cesarean. No significant difference in risk of uterine scar defect comparing
single layer versus double layer closure could be detected (RR 0.53), whereas in women with
single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However,
the authors do conclude that data is insufficient to determine the risk of uterine rupture,
dehiscence or gynecological outcomes due to insufficient power of available studies. A
recently published Randomized Controlled Trial concluded that double-layer closure with
unlocked first layer showed a better scar healing than locked single layer.
The investigators main objective is to identify if single-layer suture of the uterus during
cesarean section results in a higher rate of cesarean scar deficiency than double-layer
suture.
Interventions
Single- layer versus double- layer uterine closure Two different techniques of uterine
closure in cesarean section will be compared: single- layer versus double- layer continuous
uterotomy suture.
Standardized transvaginal sonography
Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound
machine used for all examinations is GE Voluson E10.
Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after
CS (yes/no).
Secondary outcome: Myometrial thickness at the site of uterine scar (mm).
n/a
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