Local, Methotrexate, Systemic, Uterine Ectopic Pregnancy
Conditions
Brief summary
This study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hCG) clearance and need for further management options.
Detailed description
Ectopic pregnancy is considered a life-threatening condition which requires immediate intervention. Owing to the advancements in medical technology, ectopic pregnancy can now be diagnosed in the early stages. Methotrexate (MTX) is an antimetabolite drug showing a competitive reversible binding concerning natural dihydrofolates and acting as an inhibitor of the dihydrofolate-reductase (DHFR), a key enzyme synthesizing the tetrahydrofolates needed for the synthesis of purine and pyrimidine rings.
Interventions
DRUGSystemic Methotrexate
Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).
DRUGLocal Methotrexate
Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age from 20 to 40 years. * Women with uterine ectopic pregnancy (interstitial pregnancy, cervical pregnancy, or cesarean scar pregnancy). * Gestational age is less than 9 weeks, the embryo size is smaller than 10 mm, and the serum beta-human chorionic gonadotropin (β-hCG) levels are less than 10,000 mIU/mL.
Exclusion criteria
* Patients with basal beta hCG levels less than 1500 mIU/Ml. * Any contraindications to MTX as a hepatic disorder, renal disorder and thrombocytopenia * Diabetes mellitus. * Severe vaginal bleeding or hemodynamic changes or hemoperitoneum. * History of cancer. * Ascites. * Pleural effusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for serum b-hCG remission | Post intervention for 3 months | Time for serum b-hCG remission will be recorded to be less than 20 iu/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | Post intervention for 3 months | Success rate will be recorded. |
| Time for uterine-mass disappearance | Post intervention for 3 months | Time for uterine-mass disappearance will be recorded. |
| Hospitalization time | 15 days after intervention | Hospitalization time will be recorded from admission till discharge from hospital. |
Countries
Egypt
Contacts
Primary ContactMai N Ageez, MD
Outcome results
None listed