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A randomized controlled trial on the efficacy of methotrexate in preventing post-molar gestational trophoblastic disease among patients with high-risk complete hydatidiform mole
Agnes L. Soriano-Estrella, MD, FPOGS, FPPSTD, MHPEd; Maria Anna Luisa L. Festin-Dalawangbayan, MD, FPOGS; Jimmy A. Billod, MD, DPOGS; Katherine B. Saravillo-Saniel, MD
Section of Trophoblastic Diseases, Department of Obstetrics and Gynecology, University of the Philippines-Manila, Philippine General Hospital
Methods: This was a double-blind randomized controlled trial carried out from 2007 to 2013. A total of 99 patients with high-risk complete hydatidiform mole who underwent suction curettage were randomly allocated to either the treatment or control group. The treatment group received methotrexate while the control group received a vitamin B complex. The number of patients who developed PMGTD in each group was recorded. All tests of significance were carried out at a .05 alpha level of significance, 95% confidence interval.
Results: There was no significant difference between the two groups in terms of age, gravidity, baseline ßhCG, age of gestation, and corpus size. The overall incidence of PMGTD was 27.9%. For the per protocol analysis, a total of 30 patients received chemoprophylaxis while 31 patients received placebo treatment. The total incidence of PMGTD was 16.67% for the treatment group and 38.71% for the control group. The computed risk ratio was 0.43 (95% C.I.: 0.17-1.07, p value = 0.07).
Conclusion: Results failed to reach statistical significance but the large fall-out rate may have significantly affected the outcome of the study. Methotrexate chemoprophylaxis may still be useful in preventing PMGTD, particularly in settings where the incidence of hydatidiform mole is high and there is high probability that patients will fail to follow the stringent ßhCG monitoring schedule after molar evacuation.