Hysteroscopic Resection vs Blind Dilation and Curettage (D&C) for Treatment of Cesarean Scar Pregnancy: A Randomized Clinical Trial

Study Objective: To compare the success rate of hysteroscopic resection vs dilation and curettage (D&C) for treatment of cesarean scar pregnancy (CSP). Design: Parallel-group randomized clinical trial conducted from February 2020 to February 2021 (Clinicaltrials.gov NCT04205292) Setting: Women admitted with diagnosis of CSP at a single center in Italy. Patients or Participants: Inclusion criteria were women with singleton CSP and positive embryonic/fetal heart activity, gestational age <8 weeks and 6 days at the time of randomization, and thickness of myometrial layer ≥1mm. Patients were randomized 1:1 to receive either hysteroscopic resection or D&C. A sample size of 54 women was planned. After one year of enrollment an interim analysis was performed, and 17 women were included. Interventions: In both groups, 50mg/m2 (based on DuBois formula for body surface area) of methotrexate (MTX) was injected intramuscularly at the time of randomization (day 1) and another dose at day 3. A third dose of MTX was planned in case of persistence of positive fetal heart activity at day 5. Women received D&C or hysteroscopic resection using 15 Fr bipolar mini resectoscope from 3 to 7 days after the second or third dose of MTX. Ultrasound guidance was used in both groups, if needed. Measurements and Main Results: The primary outcome was the success rate of the treatment protocol, defined as no further treatment required until the complete resolution of the CSP. Success rate was 100% in the hysteroscopic resection group and 75.0% in the D&C group (OR 7.31, 95% CI 0.30-178.57) (Table). Conclusion: Hysteroscopic resection was associated with increase in success rate of treatment of CSP, even if the statistical significance was not reached in this preliminary analysis.