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 systemic methotrexate therapy versus laparoscopic salpingostomy for tubal pregnancy.


METHODS
Multicenter randomized clinical trial.


METHODS
Departments of obstetrics and gynecology of six Dutch hospitals.


METHODS
Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic salpingostomy.


METHODS
Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks. and 16 weeks after confirmative laparoscopy.


METHODS
Health-related quality of life.


RESULTS
Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-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 functioning, 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.


CONCLUSIONS
Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy.
Department of Obstetrics and Gynecology, Academic Medical Center, University of Amsterdam, The Netherlands. P.T.NIEUWKERK@AMC.UVA.NL
P T
PT
Nieuwkerk
P J
PJ
Hajenius
W M
WM
Ankum
F
F
Van der Veen
W
W
Wijker
P M
PM
Bossuyt
D000223:Adaptation, Psychological; D000328:Adult; D001007:Anxiety / Q000453:epidemiology; D003863:Depression / Q000453:epidemiology; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008727:Methotrexate / Q000627:therapeutic use*; D011247:Pregnancy; D011274:Pregnancy, Tubal / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D011788:Quality of Life; D012489:Salpingostomy; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D008727:Methotrexate