Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-dose group | No Intervention | Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment). | |
| two-dose group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Two-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7. |
|
| 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 |
| 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% |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rashida Parveen, FCPS | Nishtar Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishtar Medical University Hospital | Multan Khurd | Pu | 66000 | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Randomized controlled trial
Not provided
Not provided
Not provided
Not provided
| 1-14 days |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |