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Comparison of effect and side effects of single dose and multiple dose methotrexate in treatment of tubal pregnancy and fertility 1 year after treatment

Effect of single dose and multiple dose methotrexate in treatment of unruptured tubal pregnancy and fertility 1 year after treatment

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201112178435N1
Enrollment
70
Registered
2011-12-27
Start date
2010-04-21
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

Treatment of unruptured tubal pregnancy. Treatment of unruptured ectopic pregnancy

Interventions

Intervention 1: In the study group, single dose regimen, 50mg /m2 intramuscular methotrexat. Intervention 2: In the control group, Intramuscular methotrexate (1mg/kg/day) was given on days 1,3,5,7 and
Treatment - Drugs
In the study group, single dose regimen, 50mg /m2 intramuscular methotrexat
In the control group, Intramuscular methotrexate (1mg/kg/day) was given on days 1,3,5,7 and citrovoram factor (0.1mg/kg/day) were administered for 2,4,6,8 days

Sponsors

Vice chancellor for research, Shahid Sadughi University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria gestational age less than 20 weeks; absence of bleeding in evidences of laparoscopic surgery and vaginal sonography; stable hemodynamic state; tubal mass equal or less than 4 cm in diameter; absence of fetal heart beat; ß -hCG less than 15000 mlU/mL, and leaning of patient to next pregnancy. Exclusion criteria Creatinine levels more than 1.5 mg/kg, Platelet levels more than 100000/ml, W.B.C levels more than 2000/ml, Higher than 2 times increased liver enzyme levels

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Success rates of treatment. Timepoint: Interval 48 hrs. on days 1,3,5,7. Method of measurement: Measurement of ß - hCG level.

Secondary

MeasureTime frame
Fertility. Timepoint: 12 months after treatment. Method of measurement: Question about fertility.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsar Tabatabaii Bafghi

Shahid Sadughi Hospital

mohammadinasab@alumnus.tums.ac.ir+98 35 1822 4001

Outcome results

None listed

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