Health Condition 1: O001- Tubal pregnancy
Conditions
Interventions
Intervention1: Letrozole: Tablet Letrozole 5 mg orally twice daily for 10 days for medical management of unruptured tubal ectopic pregnancy. Serum beta-hCG levels will be measured on Day 0, Day 4, Day
Sponsors
Dr Baba Saheb Ambedkar Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Women diagnosed with unruptured tubal ectopic pregnancy. Hemodynamically stable patients. Serum beta human chorionic gonadotropin level less than or equal to 5000 milli international units per millilitre. Mean sac diameter less than three point five centimetres with no fetal cardiac activity on transvaginal ultrasound. Patients fulfilling criteria for medical management of unruptured ectopic pregnancy. Patients willing and able to comply with post treatment follow up. Patients having access to emergency medical services in case of clinical deterioration. Patients with no contraindication to Methotrexate and Letrozole. Patients with normal baseline hematological renal and hepatic laboratory parameters. Patients who have provided written informed consent.
Exclusion criteria
Exclusion criteria: Ruptured ectopic pregnancy or signs of impending rupture. Hemodynamically unstable patients. Heterotopic pregnancy with coexisting viable intrauterine pregnancy. Pregnancy of unknown location. Presence of fetal cardiac activity in ectopic pregnancy. Serum beta human chorionic gonadotropin level more than 5000 milli international units per millilitre. Ectopic mass size equal to or more than three point five centimetres. Patients with abnormal liver renal or hematological function. Patients with immunodeficiency states. Patients with active pulmonary disease including tuberculosis. Patients with peptic ulcer disease. Patients with known hypersensitivity to Methotrexate or Letrozole. Patients unwilling or unable to comply with follow up protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum beta human chorionic gonadotropin levels following medical management of unruptured tubal ectopic pregnancy.Timepoint: Change in serum beta human chorionic gonadotropin levels following medical management of unruptured tubal ectopic pregnancy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Need for surgical intervention following medical management of unruptured tubal ectopic pregnancy.Timepoint: During treatment period and follow up until resolution of ectopic pregnancy.;Adverse effects related to letrozole and methotrexate.Timepoint: During treatment period and follow up until completion of treatment. | — |
Countries
India
Contacts
Public ContactJidiya Chirag Harshadbhai
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY DR BABA SAHEB AMBEDKAR MEDICAL COLLEGE AND HOSPITAL
Outcome results
None listed