Medical Treatment in Ectopic Tubal Pregnancy

Not Applicable

Completed

• Conditions: Ectopic Pregnancy
• Interventions: Drug: Methotrexate

• Registration Number: NCT05208034
• Lead Sponsor: Nishtar Medical University

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2022-01
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-25
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of tubal ectopic pregnancy.
• Pre-treatment beta-human chorionic gonadotrophin (β-hCG) level below 1500 mIU/ml.
• Gestational sac with largest diameter as 4cm.
• Willing to take methotrexate treatment.
• Willing to follow up.

Exclusion Criteria

• Heterotrophic pregnancy
• Persistent tubal pregnancy
• Embryonic cardiac motion
• Suspected tubal rupture
• Past history of harmful effects of methotrexate treatment on organ functions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
two-dose group	Methotrexate	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.

Primary Outcome Measures

Name	Time	Method
success rate	4-14 days	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.

Secondary Outcome Measures

Name	Time	Method
β-hCG Resolution Time	1-14 days	Time taken for β-hcg resolution to reduce below 15%
frequency of Side-effects of treatment	1-14 days	monitoring for the side effects during the treatment duration

Trial Locations

Locations (1)

Nishtar Medical University Hospital; 🇵🇰 Multān, Pu, Pakistan