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Objectives An isthmocele is a cesarean section scar defect with a depth of >2mm, and can cause both obstetric and gynecologic complications. To date, no study has determined the impact of a locked versus unlocked double-layer uterine closure technique on isthmocele prevention. The primary objective of this study is to evaluate protocol feasibility amongst our own patients and physicians, with the ultimate goal of a larger-scale randomized controlled trial (RCT). Secondary objectives include determining: (a) isthmocele incidence; (b) isthmocele measurements on postoperative transvaginal ultrasound; and (c) adverse surgical outcomes related to suture technique. Methods This is a single-centre parallel-group pilot RCT enrolling 50 participants (25 per arm) including all term singleton pregnant women >18 years old undergoing primary cesarean section. Exclusion criteria include previous uterine hysterotomy, known uterine anomalies, active labour, known bleeding disorders, and maternal connective tissue disorders. Subjects are randomized to locked versus unlocked first layer uterine closure, followed by an unlocked second layer. Women will undergo transvaginal ultrasound to evaluate isthmocele formation six months postoperatively. Results At time of submission 31 subjects have been recruited. Data will be analyzed on an intention-to-treat basis. Demographic data will be reported using descriptive statistics. Rates of isthmocele will be compared between groups using chi-square analysis; subgroup analysis of the variable suture material will be performed. Other outcomes will be assessed using a t test (continuous variables) or chi-square test (categorical variables) as appropriate. Conclusions This study design appears feasible at this time. Further outcome data will be reported once the study is complete.

Video abstract summary The background, clinical presentation and relevant pre-operative planning regarding complete uterine septums are reviewed. This is followed by an illustration of the surgical steps taken to correct such anomalies, preserving the cervical component of the septum. This is done with vaginal surgery followed by hysteroscopy with laparoscopic guidance. The technique demonstrated uses a Foley catheter balloon in one of the uterine cavities to delineate the septum, aiding in the resection of the septum in the ideal location. Technical tips are provided for additional surgical guidance. Finally, the post-operative considerations and long-term outcomes following surgical correction are discussed.