Preventing isthmocele after cesarean section (PICS): A pilot randomized controlled trial

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. 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. 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. 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. This study design appears feasible at this time. Further outcome data will be reported once the study is complete.