RCT on the Efficacy of Methotrexate for the Prevention of GTD
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|ClinicalTrials.gov Identifier: NCT01984099|
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : November 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hydatidiform Mole||Drug: Methotrexate Drug: Vitamin B Complex||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Active Comparator: Chemoprohylaxis Group
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.
Patients will be given a single course of methotrexate within fourteen days from molar evacuation.
Placebo Comparator: Control Group
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 placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
Other Name: Bee ALL
- Elevated HCG Level [ Time Frame: 4-14 weeks ]
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
- Toxicity brought about by the administration of methotrexate will be graded based on the WHO toxicity scoring system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984099
|Philippine General Hospital, University of the Philippines Manila|
|Taft Avenue, Ermita, Manila, Manila, Philippines, 1000|
|Principal Investigator:||Agnes L. Soriano-Estrella, MD||University of the Philippines Manila|