Medical Treatment in Ectopic Tubal Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ectopic Pregnancy

Intervention / Treatment
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* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: single-dose group<br>Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment). | |
| Experimental: two-dose group<br>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<br>* Two-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of Side-effects of treatment | monitoring for the side effects during the treatment duration | 1-14 days | 
| β-hCG Resolution Time | Time taken for β-hcg resolution to reduce below 15% | 1-14 days |