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Completed

NCT Number: NCT01984099

RCT on the Efficacy of Methotrexate for the Prevention of GTD

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.

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Key information

Conditions

Hydatidiform Mole Female Urogenital Diseases and Pregnancy Complications Gestational Trophoblastic Disease Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Pregnancy Complications Pregnancy Complications, Neoplastic Trophoblastic Neoplasms Urogenital Diseases

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Philippine General Hospital, University of the Philippines Manila

Taft Avenue, Ermita, Manila, Manila, 1000, Philippines

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

Patients will be given a single course of methotrexate within fourteen days from molar evacuation.

Vitamin B Complex

Drug

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

Other names: Bee ALL

Primary outcomes

  1. Elevated HCG Level

    Time frame: 4-14 weeks

    • 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.

Sponsors and collaborators

Lead sponsor

University of the Philippines

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 14, 2013
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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