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Double and Single dose Methotrexate regimens in the treatment of ectopic pregnancy

Comparison of Double and Single dose Methotrexate Protocols in the treatment of patients with tubal pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201610085485N6
Enrollment
120
Registered
2016-11-27
Start date
2016-10-22
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

medical treatment of ectopic pregnancy. Tubal pregnancy Fallopian pregnancy

Interventions

Intervention 1: In the first group (single dose), we will administer 50 mg/m2 methotrexate IM on day 1, the serum day 4 and 7 ß–hCG will be compared. If there is a drop of 15%, the treatment is consid
Treatment - Drugs
In the first group (single dose), we will administer 50 mg/m2 methotrexate IM on day 1, the serum day 4 and 7 ß–hCG will be compared. If there is a drop of 15%, the treatment is considered effective,
In the second group (double dose), we will administer 50 mg/m2 methotrexate IM on day 1 and 4, the serum day 4 and 7 ß–hCG will be compared. If there is a drop of 15%, the treatment is considered effe

Sponsors

Women's Reproductive Health Research Center, Vice chancellor for research, Tabriz University of Medi
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria are: stable hemodynamic state; adnexal mass diameter lower than 4 cm; the initial ß–hCG lower than 10000 mIU/ml; no fetal heart activity by transvaginal sonography and, the request of fertility preservation. exclusion criteria are: creatinine above 1.5 mg/dl; platelets count lower than 100000/ml; white blood cells count lower than 2000/ml and; increased liver enzymes.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Beta-hCG decrease. Timepoint: days 7, 11 and,14. Method of measurement: blood exam.

Secondary

MeasureTime frame
Abdominal pain. Timepoint: daily and per patient report. Method of measurement: by visiting the patient and patient report.;Drug side effects. Timepoint: days 4, 7 and, 11. Method of measurement: physical exam and blood tests.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNazli Navali

Tabriz University of Medical Sciences

navalin@tbzmed.ac.ir+98 41 3554 1221

Outcome results

None listed

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