Simone Engelsbel

Randomised trial of systemic methotrexate versus laparoscopic salpingostomy in tubal pregnancy

BACKGROUND Laparoscopic salpingostomy is a well-established treatment for patients with tubal pregnancy who desire to retain fertility. Another approach that preserves the fallopian tube is medical treatment. We compared systemic methotrexate and laparoscopic salpingostomy in the treatment of tubal pregnancy. Outcome measures were treatment success, tubal preservation, and homolateral tubal patency. METHODS Between January, 1994, and September, 1996, haemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy and no signs of active bleeding were randomly assigned systemic methotrexate (four 1.0 mg/kg doses of intramuscular methotrexate alternated with 0.1 mg/kg oral folinic acid) or laparoscopic salpingostomy. Treatment success was defined as complete elimination of the tubal pregnancy (serum human chorionic gonadotropin < 2 IU/L) and preservation of the tube. Homolateral tubal patency was assessed by hysterosalpingography. Analysis was by intention to treat. FINDINGS 100 patients were included in the trial. Of 51 patients allocated systemic methotrexate, 42 (82%) were successfully treated with one course; two (4%) patients needed a second course for persistent trophoblast. Surgical intervention was needed in seven (14%) patients; salpingectomy was necessary in five of these patients for tubal rupture. Of the 49 patients allocated laparoscopic salpingostomy, 35 (72%) were successfully treated by laparoscopic salpingostomy alone; salpingectomy was needed in four (8%) patients, and ten (20%) needed methotrexate for persistent trophoblast. The tube was preserved in 46 (90%) patients in the methotrexate group versus 45 (92%) in the salpingostomy group (rate ratio 0.98 [95% CI 0.87-1.1]). Homolateral tubal patency could be assessed in 81 patients: the tube was patent in 23 (55%) of 42 patients in the methotrexate group and in 23 (59%) of 39 patients in the salpingostomy group (rate ratio 0.93 [0.64-1.4]). INTERPRETATION In haemodynamically stable patients with unruptured tubal pregnancy, systemic methotrexate and laparoscopic salpingostomy were successful in treating the majority of cases. We found no significant difference between the treatments in the homolateral patency rate. Subsequent fertility outcome has to be awaited to show which treatment yields better fertility prospects.

Serum human chorionic gonadotropin measurement in the diagnosis of ectopic pregnancy when transvaginal sonography is inconclusive

OBJECTIVE To assess the accuracy of initial and repeated serum hCG measurements in the diagnosis of ectopic pregnancy (EP) in patients in whom transvaginal sonography is inconclusive and to evaluate whether patient characteristics influence the accuracy of serum hCG measurements. DESIGN Prospective study. SETTING Two large teaching hospitals in Amsterdam, the Netherlands. PATIENT(S) Three hundred fifty-four consecutively seen pregnant patients with suspected EP and inconclusive transvaginal sonographic findings. INTERVENTION(S) Serum hCG measurements. MAIN OUTCOME MEASURE(S) The performance of repeated serum hCG measurements in the diagnosis of EP was evaluated through the analysis of receiver operating characteristic curves. RESULT(S) Initial serum hCG measurements were more diagnostic in conjunction with sonographic evidence of an ectopic mass or fluid in the pouch of Douglas than in the absence of sonographic abnormalities. On repeated measurement, the course of the serum hCG concentration provided more diagnostic information than did the absolute serum hCG concentration 2 and 4 days after the start of the diagnostic process. CONCLUSION(S) The interpretation of serum hCG measurements should depend on additional findings at transvaginal sonography. A cutoff level of 1,500 IU/L is recommended for patients with an ectopic mass or fluid in the pouch of Douglas; in patients without these findings, the cutoff level should be at least 2,000 IU/L. Four days after the start of the diagnostic process, any rise in the serum hCG concentration makes the diagnosis of EP very likely.

Treatment of tubal pregnancy in The Netherlands: An economic comparison of systemic methotrexate administration and laparoscopic salpingostomy ☆ ☆☆ ★

OBJECTIVE This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic salpingostomy for the treatment of patients with tubal pregnancy. STUDY DESIGN An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/

Can noninvasive diagnostic tools predict tubal rupture or active bleeding in patients with tubal pregnancy

1. RESULTS Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were

Serum human chorionic gonadotropin clearance curves in patients with interstitial pregnancy treated with systemic methotrexate

5721 for systemic methotrexate administration and

Should patients who are suspected of having an ectopic pregnancy undergo physical examination

4066 for laparoscopic salpingostomy, with a mean difference of

Are gestational age and endometrial thickness alternatives for serum human chorionic gonadotropin as criteria for the diagnosis of ectopic pregnancy

1655 (95% confidence interval,

Is conservative surgery for tubal pregnancy preferable to salpingectomy? An economic analysis

906-

An economic evaluation of laparoscopy and open surgery in the treatment of tubal pregnancy

2414). Costs of systemic methotrexate administration were similar to those of salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was <1500 IU/L, a cutoff value that had not been previously hypothesized. In a scenario without a confirmatory laparoscopy, in which transvaginal ultrasonography and serial repeated serum human chorionic gonadotropin measurements were assumed to be as accurate as laparoscopy, systemic methotrexate therapy would have reduced total cost by

Diagnosis of ectopic pregnancy after in vitro fertilization and embryo transfer

1500 for a patient with an initial serum human chorionic gonadotropin concentration of <1500 IU/L. In such a scenario total costs would have been similar for a patient with an initial serum human chorionic gonadotropin concentration in the range of 1500 to 3000 IU/L, whereas systemic methotrexate administration would be more costly for a patient with an initial serum human chorionic gonadotropin concentration of >3000 IU/L. CONCLUSIONS Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy.