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Comparison of the effect of methotrexate dose in the treatment of patients with ectopic pregnancy

Comparison of single-dose and multi-dose methotrexate in the treatment of patients with ectopic pregnancy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120716010297N7
Enrollment
108
Registered
2020-07-11
Start date
2017-06-22
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Ectopic pregnancy. Ectopic pregnancy, unspecified

Interventions

Intervention 1: Intervention group: In the multi-dose regimen, 1 mg / kg methotrexate will be injected on days of 1, 3, 5, and 7. It should be noted that in these days, ßHCG titer will be measured bef

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Satisfaction with participating in the study Confirmation of ectopic pregnancy by ultrasound and ßHCG Stable hemodynamic status the gestational sac with the largest diameter of, 4 cm; Existence of low free fluid in the abdominal and pelvic cavity based on ultrasound.

Exclusion criteria

Exclusion criteria: The presence of active hepatitis The presence of kidney disease Use of immunosuppressive drugs History of severe allergy to methotrexate Leukopenia in patient CBC tests Hematopoiesis disorder

Design outcomes

Primary

MeasureTime frame
Serum ßHCG level. Timepoint: On days 1, 3, 5 and 7 after injection of methotrexate. Method of measurement: blood test.;Outcome of treatment. Timepoint: 6 weeks after starting treatment. Method of measurement: The outcome of treatment is assessed as follows: The success of single-dose treatment means a 5% reduction in serum hCG levels after one week of treatment and a serum level of less than 5 mIU / mL after 6 weeks of treatment. In the multi-dose regimen, a 15% decrease in hCG serum levels after 48 hours of treatment or after 4 therapeutic doses, or hCG serum levels less than 5 mIU / mL after 6 weeks of treatment will be regarded as success of treatment.

Secondary

MeasureTime frame
Methotrexate complications such as Hair loss, gastroenteritis, Neutropenia, Fever, and Increase in liver enzyme. Timepoint: during the treatment up to six weeks after. Method of measurement: Clinical observation and doctor's diagnosis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnaz Khani

Esfahan University of Medical Sciences

khani@med.mui.ac.ir+98 31 3236 7001

Outcome results

None listed

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