The Influence of Endometrial Suturing on the Risk of Uterine Scar Defect
Condition: Cesarean Wound Disruption
Study type: Interventional

Summary: 
      Caesarean section (CS) is the commonest major operation performed on women worldwide with
      progressively rising incidence. Consequently, long-term adverse sequelae due to uterine scar
      defect have been increasing. Given the association between uterine scar defect and
      gynecological symptoms, obstetric complications and potentially with subfertility, it is
      important to elucidate the etiology in order to develop preventive strategies. Surgical
      technique of uterine incision closure seems to be the most important determinant of defect
      formation. The aim of this prospective randomized study is to evaluate specifically the
      influence of inclusion versus exclusion of the endometrium during suturing the uterine
      incision on the risk to develop uterine scar defect.
    

Detailed description: 
      Caesarean section (CS) is the commonest major operation performed on women worldwide with
      progressively rising incidence. Consequently, long-term adverse sequelae due to uterine scar
      defect have been increasing. Common gynecological complains include chronic pelvic pain,
      dyspareunia, dysmenorrhea and postmenstrual spotting and infertility. Obstetric sequelae seem
      to be increasing such as cesarean scar ectopic pregnancy, placenta previa, and placenta
      accrete, all associated with major maternal morbidity and even mortality. Given the
      association between uterine scar defect and gynecological symptoms, obstetric complications
      and potentially with subfertility, it is important to elucidate the etiology in order to
      develop preventive strategies. Probable risk factors suggested are single-layer myometrium
      closure, multiple CSs and uterine retroflexion, however, surgical technique of uterine
      incision closure seems to be the most important determinant of defect formation. It is
      proposed that continuous, non-locking absorbable sutures in two layers, without including
      much of decidua and without undue tight (constricting) pulling of sutures are likely to
      result in good healing of uterine scar. The aim of this prospective randomized study is to
      evaluate specifically the influence of inclusion versus exclusion of the endometrium during
      suturing the uterine incision on the risk to develop uterine scar defect.

      Material and Methods Prospective randomized single blinded study conducted in a single
      tertiary center. All women at term (≥37 weeks of gestation) with singleton pregnancy that are
      about to go threw cesarean section attending the pre- operative clinics, will be offered to
      participate in the study. After signing informed consent, women will be block randomized for
      one of two groups: A- uterine incision repair including suturing of the endometrium, B -
      uterine incision repair without including the endometrium. All operation will be performed by
      a single highly skilled obstetrician. All other stages of operations will be similar in both
      of the groups including: low segment incision, delivery of the fetus and the placenta,
      uterine revision, intraperitoneal uterine repair, use of stratafix thread in double layer
      suturing. Operative and post operative data will be collected from the medical files
      including: operation duration, estimated blood loss, operation complications ( hypotension,
      bladder gut or vascular perforation ) , post operative complications ( hemorrhage,
      endometritis, vascular - thromboembolic event, ileus ). All women will be invited to the
      gynecologic clinics six month post operation for vaginal sonographic evaluation of the
      uterine scar and for filling questionnaire concerning possibility of uterine scar defect (
      spotting, pelvic pain, fertility abnormalities ).
    

Intervention name(s): Endometrial suturing; Non- endometrial suturing; Vaginal ultrasonography; Questionnaire
Intervention type(s): Procedure; Procedure; Device; Other
Intervention description(s): Suturing will include endometrium during cesarean incision repair; Suturing will not include endometrium during cesarean incision repair; All women will be invited six month post operation for vaginal sonographic evaluation of the uterine scar; All women will be invited six month post operation for filling questionnaire concerning possibility of uterine scar defect ( spotting, pelvic pain, fertility abnormalities )
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Uterine incision repair will include or exclude suturing of the endometrium
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: cesarean section; niche; uterine scar defect