An interventional study of Methotrexate in Ectopic Pregnancy, sponsored by Nishtar Medical University. Completed at 1 site in Pakistan. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Nishtar Medical University · Not applicable, Interventional, and Treatment
Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed multiple doses, single-dose as well as two-dose regimens have been in practice for treating EP, but no consensus exists regarding the optimum dosage regimen.
Literature reports multiple dosage regimens of MTX to be associated with increased rates of side effects. Single dose protocol has good compliance and fewer side effects but is linked with lower success rates in comparison to multiple dose protocols.
A new treatment protocol involving "two-doses" of MTX for medical management of EP was introduced in 2007 but most of the research conducted so far has been retrospective in nature and limitations in study designs. No such study in recent years has been done in Pakistan to compare the success and safety of single-dose and two-dose MTX protocols so this study was planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX in tubal EP.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment).
Women allocated to two-dose group were administered intramuscular methotrexate as 50mg/m2 at day-zero and 7 while measurement of β-hCG was ordered at day-14.
Drug: Methotrexate
Two-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7.
success rate
In single-dose group,β-hCG levels were measured at day-4 and 7 and if β-hCG decreased \>15% between day-4 and day-7, the treatment was labeled successful. In two-dose group, in case 15% reduction in β-hCG level was observed at day-14, the treatment was labeled as success.
Time frame: 4-14 days
frequency of Side-effects of treatment
monitoring for the side effects during the treatment duration
Time frame: 1-14 days
β-hCG Resolution Time
Time taken for β-hcg resolution to reduce below 15%
Time frame: 1-14 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Jul 2021, 18 months.
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methotrexate
Nishtar Medical University