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Effects of methotrexate and combination of methotrexate-mifepristone in treatment of ectopic pregnancy

The comparative study of the effects of methotrexate and combination of methotrexate-mifepristone in treatment of ectopic pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201010033461N3
Enrollment
66
Registered
2010-10-31
Start date
2010-08-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy with abortive outcome. Pregnancy with abortive outcome

Interventions

Intervention 1: 50mg/m2 methotrexate IM, with single dose oral placebo (same as mifepristone). Intervention 2: single dose of methorexate IM + 600mg mifepoistone oraly.
Placebo
Treatment - Other
50mg/m2 methotrexate IM, with single dose oral placebo (same as mifepristone)
single dose of methorexate IM + 600mg mifepoistone oraly

Sponsors

Kermanshah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: stable Hemodynamic state, Without Bleeding or hemo-peritoneum, un ruptured ectopic pregnancy, ectopic pregnancy mass without FHR, ectopic pregnancy mass smaller than 4cm, BHCG less than 1500 mlu/ml, no contradiction of use of methotrexate or mifepristone Exclusion criteria: decrease in serum BHCG, BHCG less than1500 mlu/ml and depletion after 48 h, history of liver and renal diseases, hematologic or others disorders such as: glaucoma, porphyria, thalassemia, ulcerative colitis, heart diseases, psychological diseases, corticosteroid use more than 6 months, prior sensitivity to methotrexate or mifepristone

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Ectopic Pregnancy treatment. Timepoint: Days 4, 7, 11, and 14. Method of measurement: Beta hCG level.

Secondary

MeasureTime frame
Need to second methotrexate injection. Timepoint: from 4th to 7th day. Method of measurement: BhcG level.;Rate of infection. Timepoint: 4th, 7th and 11th day after intervention. Method of measurement: temperature more than 38 degree centigrade.;Surgical intervention. Timepoint: 4th day after intervention. Method of measurement: laparatomy.;Number of days required to reduce BhcG level. Timepoint: after 4th day. Method of measurement: Beta hcG level.;Hospital stay. Timepoint: from admission to discharge. Method of measurement: Number of hospitalization dayshospitalization.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFiroozeh Veisi

Kermanshah University of Medical Sciences

f_veisi@kums.ac.ir firoozehveisi@yahoo.com+98 83 1427 6309

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026