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Comparison between single and double dose of Methotrexate in Ectopic Pregnancy

Comparison between single and double dose of Methotrexate in Ectopic Pregnancy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013051110089N3
Enrollment
146
Registered
2013-09-03
Start date
2013-04-21
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

Tubal pregnancy. Fallopian pregnancy

Interventions

Intervention 1: After diagnosis of tubal EP and determining basic ß–hCG titration level and checking kidney, liver function tests and Complete Blood Count (CBC) Methotrexate with a brand name EBETREX
Treatment - Drugs
After diagnosis of tubal EP and determining basic ß–hCG titration level and checking kidney, liver function tests and Complete Blood Count (CBC) Methotrexate with a brand name EBETREX manufactured by

Sponsors

Vice Chancellor for Research, Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Andexal mass with a size of 4 cm at maximum ; 2- ß–hCG titration level less than15000 mIU/mL; 3- Stable hemodynamic status -Blood Pressure > 90/60 mmHg and nonexistence of tachycardia ( Pulse Rate less than 100/min); 4-No fetal heart activity in gestational sac; 5- Consent for Methotrexate therapy and follow-up; 6- Normal laboratory tests(Platelet count more than 120000/µL , Serum Creatinin less than 1.2mg/dL or Aspartate aminotransferase less than double of normal level). Exclusion criteria: This study has not exclusion criteria .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Treatment response in terms of basic ß-hCG titration level by ELIZA technique. Timepoint: After first week of treatment and 6 weeks follow-up period. Method of measurement: Determining ß-hCG titration level before treatment by ELIZA technique.;Therapeutic response to methotrexate. Timepoint: Day 4 and day 7, and its repetition weekly until 6 weeks. Method of measurement: Visit the patient and determining serum ß–hCG titration level by ELIZA technique.;Treatment response in terms of longest ectopic mass diameter on Transvaginal Sonography. Timepoint: After first week of treatment and 6 weeks follow-up period. Method of measurement: Determining the longest ectopic mass diameter in terms of Ultrasound report before treatment.

Secondary

MeasureTime frame
Follow-up days. Timepoint: After treatment and since first week of follow-up. Method of measurement: Duration of Treatment and follow-up until ß–hCG titration level declined to less than 10 mIU/mL in terms of day by ELIZA technique.;Methotrexate side effects(Abdominal pain,Gastrointestinal symptoms,Alopecia ,Mucositis,Leukocyte count<4000,Platelet count<120000, Aspartate aminotransferase more than double level of normal). Timepoint: After treatment and on first week of follow up. Method of measurement: History, checking liver function tests and Complete Blood Count (CBC).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAidin Raoofinia

Guilan University of Medical Sciences

A.Raoofinia@gmail.com+98 13 1322 5624

Outcome results

None listed

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