SINGLE-DOSE METHOTREXATE - AN EXPANDED CLINICAL-TRIAL

OBJECTIVE: Our purpose was to report an expanded clinical trial with a nonlaparoscopic approach to ectopic pregnancy diagnosis combined with single-dose intramuscular methotrexate treatment. STUDY DESIGN: A prospective cohort of 120 women with an ectopic pregnancy less-than-or-equal-to 3.5 cm in greatest dimension was enrolled. RESULTS: Patients had a mean age of 26.1 +/- 6.2 years, a mean gravidity of 3.2 +/- 1.6, and a mean parity of 0.97 +/- 1.0. The mean human chorionic gonadotropin titer before treatment initiation was 3950 +/- 1193 mIU/ml. Transvaginal ultrasonography visualized cardiac activity in 14 (11.7%) patients, with an ectopic mass visualized in 113 (94.2%). The mean time to resolution in the 113 (94.2%) subjects successfully treated was 35.5 +/- 11.8 days. Four (3.3%) patients required a second methotrexate dose on day 7. No biochemical or clinical side effects occurred. Posttreatment hysterosalpingograms demonstrated tubal patency on the ipsilateral side in 51 of 62 (82.3%) patients. Of those attempting pregnancy, 79.6% were pregnant, 87.2% intrauterine and 12.8% ectopic. The mean time to achieve pregnancy was 3.2 +/- 1.1 months. CONCLUSIONS: This regimen requires minimal laboratory follow-up and eliminates leukovorin recovery, making it the regimen of choice for medical treatment of unruptured ectopic pregnancy.