SYSTEMIC METHOTREXATE THERAPY VERSUS LAPAROSCOPIC SALPINGOSTOMY IN PATIENTS WITH TUBAL PREGNANCY - PART I - IMPACT ON PATIENTS HEALTH-RELATED QUALITY-OF-LIFE

Objective: To compare patients' health-related quality of life after s ystemic methotrexate therapy versus laparoscopic salpingostomy for tub al pregnancy. Design: Multicenter randomized clinical trial. Setting: Departments of obstetrics and gynecology of six Dutch hospitals. Patie nt(s): Hemodynamically stable patients with a laparoscopically confirm ed unruptured tubal pregnancy without signs of active bleeding, who we re randomly assigned to undergo either systemic methotrexate therapy o r laparoscopic salpingostomy. Intervention(s): Standard health-related quality of life questionnaires administered before and 2 days, 2 week s, 4 weeks, and 16 weeks after confirmative laparoscopy. Main Outcome Measure(s): Health-related quality of life. Result(s): Health-related quality of life was impaired most severely 2 days after confirmative l aparoscopy in both treatment groups and improved during follow-up. Hea lth-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic salpingostomy. Medically treated patients had more limitations in physical functioning, role fu nctioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients. Co nclusion(s): Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic salp ingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account wh en deciding on the appropriate therapy for tubal pregnancy. (Fertil St eril(R) 1998; 70:511-7. (C)1998 by American Society for Reproductive M edicine.).