NCT05208034

Medical Treatment in Ectopic Tubal Pregnancy

Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Nishtar Medical University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ectopic Pregnancy

Interventions

Type	Name	Description
DRUG	Methotrexate	Two-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2022-01-26
• Last updated: 2022-02-09

Locations

1 site across 1 country: Pakistan