Health Condition 1: O001- Tubal pregnancy
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Department Of Pharmacology
Eligibility
Inclusion criteria
Inclusion criteria: 1.Treatment na ve unruptured tubal ectopic pregnancy. 2.Hemodynamically stable patient 3.No contraindications to Methotrexate. 4.Willingness to give informed written consent.
Exclusion criteria
Exclusion criteria: 1.Ruptured ectopic pregnancy 2.Signs of hemodynamic instability. 3.Contraindication to methotrexate 4.Pre-existing hepatic/renal dysfunction, immunodeficiency, or hypersensitivity to MTX 5.Patient who has already received methotrexate from outside 6.Patient who are not willing to give consent for the study. 7.Chronic ectopic pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of efficacy of methotrexate in the management of unruptured tubal ectopic pregnancy Timepoint: Time taken for normalization of Beta HCG(serial monitoring) OR 6 week after last injection of Methotrexate whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study pharmacokinetics of Methotrexate-C-max, Area under curve 2.To monitor the adverse drug effects associated with methotrexate 3. To study the correlation of methotrexate dose with efficacy, safety & pharmacokinetic dataTimepoint: Time point for pharmacokinetic analysis- Post methotrexate injection(0hour,2hour,12hour, 24hour) | — |
Countries
India
Contacts
Public ContactDr Lekha Saha
PGIMER Chandigarh
Outcome results
None listed