A Phase 3 interventional study of Methotrexate and Vitamin B Complex in Hydatidiform Mole, sponsored by University of the Philippines. Completed at 1 site in Philippines. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by University of the Philippines · Phase 3, Interventional, and Treatment
A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole.
A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole.
Women who will undergo suction curettage for complete hydatidiform mole at the Philippine General Hospital, who are at risk for developing postmolar gestational trophoblastic disease will be included in the study. Patients will receive either a single course of methotrexate or vitamin B complex (Benutrex) within fourteen days from molar evacuation. Patients' serum beta HCG will be monitored 1 week after molar evacuation and then every 2 weeks until the titers become normal for three consecutive determinations, then monthly for 6 months (every 2 months for the next 6 months).
38 studies on the registry are indexed under Gestational Trophoblastic Disease; 17 are open to participants now.
This study's enrollment of 99 is above the median of 61 across 28 interventional studies indexed under Gestational Trophoblastic Disease.
Browse Gestational Trophoblastic Disease studies →University of the Philippines is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
must have at least one of the following risk factors for the development of postmolar gestational trophoblastic disease:
Exclusion Criteria:
Chemoprohylaxis Group: the treatment group, will be given a single course of methotrexate within fourteen days from molar evacuation. Methotrexate will be given at 0.4 mg/kg intramuscularly per day for 5 days. No chemotherapy will be administered if the hemoglobin is lower than 10 g/L, WBC is less than 3.0 x 10 g/L or more than 10.0 x 10 g/L, absolute neutrophil count is less than 1.5, platelet count is lower than 100,000/cu.cc., patient has elevated liver and renal function test and has concurrent infection.
Drug: Methotrexate
Control Group: will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
Drug: Vitamin B Complex
Patients will be given a single course of methotrexate within fourteen days from molar evacuation.
Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
Also known as: Bee ALL
Elevated HCG Level
1. Diagnosis of postmolar gestational trophoblastic diseases will be based on the occurrence of any of the following conditions: * high level of hCG more than 4 weeks post-evacuation (serum level of 20,000mlU/m) * progressively increasing or plateuing hCG values at any time after evacuation (minimum of 3 weekly determinations) * clinical or histologic evidence of metastasis at any site * persistently elevated hCG titer at 14 weeks post-evacuation * elevation of previously normal hCG titer after evacuation provided the diagnosis of pregnancy is excluded 2. Toxicity brought about by the administration of methotrexate will be graded based on the WHO toxicity scoring system.
Time frame: 4-14 weeks
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Hydatidiform Mole
University of the Philippines