Ectopic Pregnancy
Conditions
Keywords
methotrexate, letrozole
Brief summary
The objective of the study is to compare the effectiveness of single-dose methotrexate and letrozole + single-dose methotrexate in treating ectopic pregnancy, focusing on treatment success, changes in ß-hCG levels, hemogram and biochemical markers, surgical intervention due to rupture, fertility preservation, and reduction of maternal morbidity, mortality, and healthcare costs. This is a prospective study conducted on 60 ectopic pregnancy patients at Van Yuzuncu Yil University from June 2021 to September 2022. Thirty patients received single-dose methotrexate, while the other thirty received letrozole + single-dose methotrexate. Inclusion criteria were ß-hCG \<5000 mIU/mL, ectopic mass \<3-4 cm, no persistent abdominal pain, no fetal cardiac activity, and no contraindications to the treatments. Outcomes measured included treatment success, blood parameter changes, and the need for surgical intervention.
Interventions
DRUGLetrozole
Patients in the MTX + letrozole group received letrozole tablets (Femara 2.5 mg) once daily for ten days starting from the day of MTX administration.
DRUGMethotrexate
After confirming the diagnosis of tubal ectopic pregnancy, each patient will receive a single dose of intramuscular MTX (50 mg/m² MTX) on the same day
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with ectopic pregnancy according to the diagnostic criteria * Patients with β-hCG levels \<5000 mIU/ml, * Patients without serious or persistent abdominal pain * Patients without fetal cardiac activity observed * Ectopic mass size smaller than 3-4 cm * Patients without contraindications for methotrexate and letrozole
Exclusion criteria
* Ruptured ectopic pregnancies * Hemodynamically unstable patients * Patients with acute abdomen or intra-abdominal bleeding * Patients with fetal cardiac activity * β-hCG levels below 500 mIU/mL or above 5000 mIU/mL * Patients non-compliant with treatment * Ectopic pregnancy size over 40 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in β-hCG levels | On day 1, 4 and 7 | Serum β-hCG titration was monitored on days 1, 4, and 7 using the same laboratory kit. |
Secondary
| Measure | Time frame |
|---|---|
| Need of surgical interventions | On the days of admission. |
| Hospitalization Days | Through study completion, an average of 3 weeks |
Countries
Turkey (Türkiye)
Outcome results
None listed