Ectopic Pregnancy
Conditions
Keywords
ectopic pregnancy, letrozole, methotrexate
Brief summary
A randomized clinical trial using oral letrozole 10mg/day for 7 days, for treating early cases of ectopic pregnancy, compared to intramuscular methotrexate
Detailed description
This is a multicenter randomized clinical trial on the use of letrozole in the medical treatment of tubal ectopic pregnancy. Tubal ectopic pregnancy is an abnormal pregnancy in the fallopian tube. They occurred in about 8% of all pregnancies presenting to the emergency department. Methotrexate (MTX), administered systemically (intramuscularly), is a widely used medication for the treatment of unruptured tubal ectopic pregnancies and has been recommended as first-line treatment for early cases of ectopic pregnancy. Letrozole is an aromatase inhibitor and can suppress estradiol levels. Some recent studies have shown that its use can be applied in cases of ectopic pregnancy. The aim of this non-inferiority clinical trial is to verify that letrozole treatment is non-inferior to methotrexate treatment in women with early ectopic pregnancy who are hemodynamically stable.
Interventions
10 mg of letrozole PO for 7 days
100 mg of methotrexate IM, single dose
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the outcome and the interventions, blinding was not considered an issue.
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Diagnosis of ectopic pregnancy * Desire for reproduction * Ease of return * Undetermined pregnancy location with abnormal hCG growth * Presence of a heterogeneous adnexal mass on pelvic ultrasound suggestive of a tubal ectopic pregnancy with an hCG level ≤ 3000 mIU/ml * Absence of fetal cardiac activity * Average diameter of the adnexal mass ≤ 3.5 cm * Hemodynamically stable * No significant abdominal pain (i.e, \< 6 on a visual analog scale)
Exclusion criteria
* Presence of a significant amount of free fluid in the pelvis (as assessed by the ultrasound technician) * Allergy to methotrexate or letrozole * A reduction in β-hCG ≥ 50% in 2 measurements with 48 hours between them or ≥ 85% in 4 days, or ≥ 95% in 7 days before randomization * Abnormal liver function test (Alanine transaminase (ALT) ≥ 2 times the upper limit of normal) * Abnormal renal function test (glomerular filtration rate ≤ 45 ml/min) * Hemoglobin \<10 g/dl * Platelets \<120.000/ml * Presence of heterotopic pregnancy * Do not wish to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| levels of beta fraction of human chorionic gonadotropin (beta-hCG) | weekly after the first day of intervention until reaching levels of beta-hCG below 5 milli-International unit per milliliter (assessed up to 5 months) | On day 4 (D4) and 7(D7), beta-hCG levels will be measured. If a reduction equal or above 15% between D4 and D7 were observed, serum beta-hCG will be measured until reach levels \< 5 milli-International unit per milliliter (mIU/ml). |
Countries
Brazil
Contacts
Primary ContactRicardo F Savaris, MD, PhD
Outcome results
None listed