RCT on the Efficacy of Methotrexate for the Prevention of GTD (NCT01984099) | Clinical Trial Compass
CompletedPhase 3
RCT on the Efficacy of Methotrexate for the Prevention of GTD
Philippines99 participantsStarted 2011-12
Plain-language 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.
Who can participate
Age range35 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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