Clinical Trial: RCT on the Efficacy of Methotrexate for the Prevention of GTD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 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.

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).


Sponsor: University of the Philippines

Current Primary Outcome: Elevated HCG Level [ Time Frame: 4-14 weeks ]

  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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of the Philippines

Dates:
Date Received: November 7, 2013
Date Started: December 2011
Date Completion:
Last Updated: November 7, 2013
Last Verified: November 2013