Medical Treatment in Ectopic Tubal Pregnancy

Nishtar Medical University

Status: Completed

Conditions: Ectopic Pregnancy

Treatments: Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT05208034

NishtarMU12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

single-dose group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Drug: Methotrexate