RCT on the Efficacy of Methotrexate for the Prevention of GTD

University of the Philippines

Status and phase: Completed; Phase 3

Conditions: Hydatidiform Mole

Treatments: Drug: Methotrexate; Drug: Vitamin B Complex

Study type: Interventional

Funder types: Other

Identifiers

NCT01984099

NIH 2009-044

Details and patient eligibility

About

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.

Full 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).

Enrollment: 99 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 2 patient groups, including a placebo group

Chemoprohylaxis Group

Active Comparator group

Description:

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.

Treatment:

Drug: Methotrexate

Control Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Vitamin B Complex