Health Condition 1: null- Low risk Gestational Trophoblastic Disease
Conditions
Interventions
Intervention1: Methotrexate Infusion: MTX 300mg/m² in 500 ml of normal saline given as an IV infusion over six hours followed by folinic acid 15 mg per orally every 6 hours for four doses starting 24
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
Inclusion criteria: Patients with abnormal hCG regression following any type of pregnancy (molar, term, abortion,ectopic) ie (1)hCG plateau for 4 consecutive values over 3 weeks (2)hCG rise of >10% for 3 values over 2 weeks (3)hCG persistence 6 months after molar pregnancy evacuation For staging and pretreatment evaluation, all patients will undergo complete physical and pelvic examination, complete blood cell count, urinalysis, liver and renal function tests, and chest x-ray. Ultrasonography and/or computed tomographic scanning will be performed when clinically indicated. Diagnosis, staging, and risk scoring will be as per International Federation of Gynecology and Obstetrics (FIGO) 2000 criteria for diagnosis and staging for GTN. Low risk gestational trophoblastic disease FIGO score <6
Exclusion criteria
Exclusion criteria: •Choriocarcinoma •Any patient with renal, hepatic,haematological disease •Pregnancy •Prognostic score > 6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary remission rate or Complete response (Proportion)Timepoint: 5years | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to cure Number of cycles required for complete response Toxicity & Side effects Cost of treatment Timepoint: 5 years | — |
Countries
India
Contacts
Public ContactAnitha Thomas
Christian Medical College, Vellore, India
Outcome results
None listed