A Randomized Clinical Study Based on Comparison Between Closure of Uterine Incision With Vicryl 2/0 Versus Vicryl 1 in Development of Uterine Niche.
Condition: Cesarean Section; Dehiscence
Study type: Interventional

Summary: 
      The first group patients underwent double layer closure with split thickness with vicryl 2/0,
      in continuous, non- locked, 1 cm apart sutures, study group, and the second group, women
      underwent double layer closure with split thickness with vicryl 1, in continuous, non-
      locked, 1 cm apart sutures, control group. Then, all women in the study were followed up for
      development of niche within 1 to 6 weeks. The assessment after one week postpartum was with
      using trans-abdominal Ultrasound, then after two to six weeks postpartum with transvaginal
      Ultrasound
    

Detailed description: 
      Caesarean section rates have increased worldwide over the past decades from 6.7 to 19.1%,
      with a current European CS rate of 25% of all births. CS is considered to be a safe procedure
      that can be life saving for both mother and child but the increasing trend draws more
      attention to adverse outcomes related to CSs. A relatively new long-term sequela is the niche
      in the uterine caesarean scar. A niche is defined as "an indentation at the site of the
      uterine caesarean scar with a depth of at least 2 mm on ultrasound" and is present in 56-84%
      of women after one or more CSs .

      It is realized that almost all of the increase in cesarean section rate is due to the
      increase in repeat operations, and primary cesarean deliveries for dystocia and fetal
      distress. These can be attributed to obstetric factors as increased primary cesarean delivery
      rate, failed induction. Maternal factors as Increased proportion of women > age 35, increased
      nulliparous women, increased elective primary cesarean deliveries and factors relating to the
      physician as Malpractice litigation concerns .

      The hypotheses can be divided into surgery-related factors and patient related factors. In
      their paper they focused on surgery-related factors since these could be easily modified and
      studied in future RCTs .

      These surgical-related factors include low (cervical) location of the uterine incision during
      a CS, Incomplete closure of the uterine wall, due to single-layer, endometrial saving closure
      technique or use of locking sutures and Surgical activities that may induce adhesion
      formation (i.e., non-closure of peritoneum, inadequate hemostasis, applied sutures, use of
      adhesion barriers).

      Without questions, the uterine niche presents a pathology that requires evaluation and
      intervention to mitigate its prevalence. The aim of this study is to compare between closures
      of uterine incision with Vicryl 2/0 versus Vicryl 1 in developing a uterine niche.
    

Intervention name(s): Vicryl 1; Vicryl 2/0
Intervention type(s): Procedure; Procedure
Intervention description(s): Double layer closure with split thickness with vicryl 1, in continuous, non-locked, 1 cm apart sutures.; Double layer closure with split thickness with vicryl 2/0, in continuous, non-locked, 1 cm apart sutures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention