NCT01984099

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University of the Philippines · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hydatidiform Mole

Interventions

Type	Name	Description
DRUG	Methotrexate	Patients will be given a single course of methotrexate within fourteen days from molar evacuation.
DRUG	Vitamin B Complex	Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-11-14
• Last updated: 2020-04-17

Locations

1 site across 1 country: Philippines