RCT on the Efficacy of Methotrexate for the Prevention of GTD

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of the Philippines
• Treatments: Folic Acid; Methotrexate; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• diagnosis and molar evacuation done at the Department of Obstetrics and Gynecology of the Philippine General Hospital;

• patients who will undergo suction curettage for evacuation of molar pregnancy;

• histopathologically confirmed complete hydatidiform mole;

• must have at least one of the following risk factors for the development of postmolar gestational trophoblastic disease:

• uterine size larger than age of gestation of more than 6 weeks

• serum B-hCG titer more than or equal to 100,000 mlU/ml

• theca lutein cysts more than or equal to 6 cms in size

• gravidity of 4 or more

• recurrent molar pregnancy

• medical complications arising from trophoblastic proliferation such as DIC, pre-eclampsia, thyrotoxicosis, pulmonary insufficiency

• complete data;

• patient must have at least one year of regular follow-up and hCG monitoring following onset of remission;

• should have signed the consent form.

Exclusion Criteria:

• patients who are lost to follow-up or with incomplete data

• patients who underwent total hysterectomy for evacuation of molar pregnancy

• patients who are unable to complete the methotrexate treatment

• patients who get pregnant within a year following remission

• patients with a previous history of gestational trophoblastic neoplasia

• patients with medical problems/complications that inhibit administration of methotrexate