Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT05208034
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Treatment in Ectopic Tubal Pregnancy
Sponsor:
Nishtar Medical University
Organization:
Study Overview
Official Title:
Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: