Success and spontaneous pregnancy rates following systemic methotrexate versus laparoscopic surgery for tubal pregnancies: a randomized trial.
OBJECTIVE
To determine which treatment should be offered to women with a non-ruptured tubal pregnancy: a single dose of methotrexate (MTX) or laparoscopic surgery.


METHODS
Prospective, randomized, open multicenter study.


METHODS
Seven Danish departments of obstetrics and gynecology.


METHODS
A total of 106 women diagnosed with ectopic pregnancy (EP).


METHODS
Between March 1997 and September 2000, 1,265 women were diagnosed with EP, 395 (31%) were eligible, 109 (9%) were randomized of whom 106 had an EP. The study was originally powered to a sample size of 422 patients. The women were randomized to either medical (MTX; 53) or surgical (laparoscopic salpingotomy; 53) treatment. Follow-up by questionnaire and through national patient databases for a maximum of 10 years.


METHODS
Uneventful decline of plasma-human chorionic gonadotropin to less than 5 IU/L, rates of spontaneous, subsequent intrauterine, and recurrent ectopic pregnancies.


RESULTS
The success rates were 74% following MTX treatment and 87% after surgery (n.s.); the subsequent spontaneous intrauterine pregnancy rate was 73% after MTX and 62% after surgery; and the EP rate was 9.6% after MTX and 17.3% following surgery (n.s.).


CONCLUSIONS
In women with an EP, who are hemodynamically stable and wishing to preserve their fertility, medical treatment with single dose MTX tends to be equal to treatment with laparoscopic surgery regarding success rate, complications, and subsequent fertility. Although the two treatment modalities seemed to be similar in outcome, it is crucial that the diagnosis is based on a high-quality ultrasonographic evaluation, as two patients had intrauterine pregnancies despite fulfilling the diagnostic algorithm for EP.
Krag Moeller
Lars Bo
LB
Department of Obstetrics and Gynecology, Hvidovre Hospital, Hvidovre, Denmark. lkm@daldnet.dk
Moeller
Charlotte
C
Thomsen
Sten Grove
SG
Andersen
Lars Franch
LF
Lundvall
Lene
L
Lidegaard
Øejvind
Ø
Kjer
Jens Joergen
JJ
Ingemanssen
Jens Lindgren
JL
Zobbe
Vibeke
V
Floridon
Charlotte
C
Petersen
Janne
J
Ottesen
Bent
B
D000328:Adult; D006063:Chorionic Gonadotropin / Q000097:blood; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D011247:Pregnancy; D011274:Pregnancy, Tubal / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D014463:Ultrasonography; D055815:Young Adult
D006063:Chorionic Gonadotropin; D008727:Methotrexate