Objective: To evaluate safety and efficacy of intrasaccular methotrexate (MTX) for treatment of ectopic pregnancy (EP).
Design: Longitudinal nonrandomized trial of MTX treatment of EP.
Setting: Department of Obstetrics and Gynecology (A. Béclère Public Hospital, Clamart, France Paris-Sud University).
Patients: One hundred patients with an EP visualized by sonography. Patients were 31.4 +/- 4.8 years old, para 0 to 4, and gravida 0 to 7. Twelve patients had a past history of EP, and 18 had previously undergone tubal surgery. Inclusion score for proposed medical treatment used six criteria graded from 1 to 3: gestational age, initial hCG level, P level, existence of abdominal pain, size of hemoperitoneum, and diameter of hematosalpinx. Eleven patients had an EP with cardiac activity. Treatment consisted of MTX, 1 mg/kg, given locally under transvaginal sonographic control.
Results: Eighty-three of 100 patients were considered to be completely cured (return of hCG to < 10 mIU/mL). The success rate was 92.8% with an initial hCG level < 5,000 mIU/mL and 87% when the score was < or = 12. Seven of the 11 patients with an EP with cardiac activity were treated successfully, including 5 of 7 when the initial score was < or = 12, and all failures concerned cases with an initial score > 12. Twenty-eight of 83 patients treated successfully required more than one injection of MTX (additional doses being given intramuscularly) because of nonresolution of hCG levels. Follow-up hysterosalpingography was performed in 80 patients showing 90% tubal patency on the side of the treated EP. Of 58 patients wishing pregnancy, 34 pregnancies occurred, including 25 ongoing or delivered. We observed a low recurrence rate of EP (3 with 1 on the same side).
Conclusion: Treatment by initial transvaginal injection of MTX under sonographic control appears to be simple and effective, with no demonstrable untoward effects. The tubal patency and subsequent fertility obtained appear satisfactory. The highest success rate is observed when hCG level is under 5,000 mIU/mL and/or a pretherapeutic score < or = 12 when EP is visualized by sonography.