Clinical trial NCT01984099: RCT on the Efficacy of Methotrexate for the Prevention of GTD
Official title: The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hydatidiform Mole
Keywords: Postmolar Gestational Trophoblastic Disease, Hydatidiform Mole
Lead sponsor: University of the Philippines
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 99
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility 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

Primary outcomes:
measure: Elevated HCG Level
timeFrame: 4-14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taft Avenue, Ermita, Manila
country: Philippines
facility: Philippine General Hospital, University of the Philippines Manila
state: Manila
Study officials:
affiliation: University of the Philippines Manila
name: Agnes L. Soriano-Estrella, MD
role: PRINCIPAL_INVESTIGATOR
References: