Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Gestational Trophoblastic Disease

Hydatidiform Mole

Nevus

Trophoblastic Neoplasms

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Pregnancy Complications

Pregnancy Complications, Neoplastic

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Chrysarobin

Methotrexate

Folic Acid

Liver Extracts

Vitamin B Complex

Trace Elements

Antimetabolites

Enzyme Inhibitors

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Folate

Vitamin B9

Folinic Acid

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.

Control Group: will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.

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.

Agnes L. Soriano-Estrella, MD

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).

RCT on the Efficacy of Methotrexate for the Prevention of GTD

The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole

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.

University of the Philippines

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RCT on the Efficacy of Methotrexate for the Prevention of GTD	NCT01984099	Hydatidiform Mo...	Methotrexate Vitamin B Compl...	35 Years -	University of the Philippines
RCT on the Efficacy of Methotrexate for the Prevention of GTD	NCT01984099	Hydatidiform Mo...	Methotrexate Vitamin B Compl...	35 Years -	University of the Philippines

Spots Global Cancer Trial Database for postmolar gestational trophoblastic disease, hydatidiform mole