Spots Global Cancer Trial Database for RCT on the Efficacy of Methotrexate for the Prevention of GTD
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Trial Identification
Brief Title: RCT on the Efficacy of Methotrexate for the Prevention of GTD
Official Title: The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole
Study ID: NCT01984099
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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).
Eligibility
Minimum Age: 35 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Philippine General Hospital, University of the Philippines Manila, Taft Avenue, Ermita, Manila, Manila, Philippines
Contact Details
Name: Agnes L. Soriano-Estrella, MD
Affiliation: University of the Philippines Manila
Role: PRINCIPAL_INVESTIGATOR
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