Tubal Pregnancy Unruptured
Conditions
Keywords
Tubal pregnancy, Methotrexate, Letrozole
Brief summary
It is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. Treatment of tubal pregnancy with letrozole would allow to avoid the adverse effects of methotrexate (MTX) in women refusing surgery. The aim was to compare the effectiveness of letrozole with MTX in the management of tubal pregnancy.
Detailed description
A prospective cohort study is conducted among women with tubal pregnancy. Women with increasing B-human chorionic gonadotropin (B-hCG) concentrations are included. Two study arms were planned: i) women treated with MTX: MTX in a single dose of 100 mg intravenously on day 0; ii) women treated with letrozole: letrozole at a daily dose of 5 mg orally for 10 days from day 0. The inclusion criteria included B-hCG concentration up to 3000 mIU/ml and no contraindications to conservative treatment. Women who did not meet criteria for conservative treatment were excluded. Blood parameters (B-hCG, hemoglobin, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7. Cases of treatment failure were counted, i.e. the need to perform laparoscopy due to tubal pregnancy rupture, pain, increase in B-hCG concentration. The women were given the option to choose the treatment used in the study. All enrolled women gave informed written consent to participate in the study.
Interventions
DRUGLetrozole as monotherapy
Letrozole 5 mg daily orally for 10 days from day 0
DRUGMTX as monotherapy
MTX in a single dose of 100 mg intravenously on day 0
Sponsors
Jagiellonian University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* tubal pregnancy confirmed on pelvic ultrasound * increasing serum B-hCG concentrations in at least two subsequent measures * serum B-hCG concentration ≤ 3000 mIU/ml
Exclusion criteria
* free fluid in lesser pelvis on pelvic ultrasound * positive fetal heartbeat on pelvic ultrasound * abdominal pain * heterotopic pregnancy * contraindications to MTX
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of the treatment | up to 6 months | Conversion rate to laparoscopy due to tubal rupture, pain, serum B-hCG increase in the course of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of treatment on bone marrow function (red blood cells) | up to 6 months | Changes in red blood cell count (T/l) in the course of treatment (day 0,4,7) |
| The effect of treatment on bone marrow function (white blood cells) | up to 6 months | Changes in white blood count (G/l) in the course of treatment (day 0,4,7) |
| The effect of treatment on bone marrow function (platelets) | up to 6 months | Changes in platelet count (G/l) in the course of treatment (day 0,4,7) |
| The effect of treatment on liver function (total bilirubin) | up to 6 months | Changes in the concentrations of serum total bilirubin (mg/dl) in the course of treatment (day 0,4,7) |
| The effect of treatment on bone marrow function (hemoglobin) | up to 6 months | Changes in hemoglobin concentration (g/dl) in the course of treatment (day 0,4,7) |
| The effect of treatment on liver function (aspartate transaminase) | up to 6 months | Changes in the concentrations of aspartate transaminase (IU/l) in the course of treatment (day 0,4,7) |
| The effect of treatment on liver function (gamma-glutamyltransferase) | up to 6 months | Changes in the concentrations of gamma-glutamyltransferase (IU/l) in the course of treatment (day 0,4,7) |
| The effect of treatment on kidney function (urea) | up to 6 months | Changes in the concentrations of serum urea (mmol/l) in the course of treatment (day 0,4,7) |
| The effect of treatment on kidney function (creatinine) | up to 6 months | Changes in the concentrations of serum creatinine (mg/dl) in the course of treatment (day 0,4,7) |
| The effect of treatment on liver function (alanine transaminase) | up to 6 months | Changes in the concentrations of alanine transaminase (IU/l) in the course of treatment (day 0,4,7) |
Countries
Poland
Outcome results
None listed