RCT on the Efficacy of Methotrexate for the Prevention of GTD

Hydatidiform Mole Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984099
• Other study ID #: NIH 2009-044
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: April 2020
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Hydatidiform Mole

Intervention

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

Locations

Country	Name	City	State
Philippines	Philippine General Hospital, University of the Philippines Manila	Taft Avenue, Ermita, Manila	Manila

Sponsors (1)

Lead Sponsor	Collaborator
University of the Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elevated HCG Level	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.	4-14 weeks