Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy

Hormozgan University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Pregnancy, Ectopic

Treatments: Drug: Multipe; Drug: Single

Study type: Interventional

Funder types: Other

Identifiers

NCT01662167

U1111-1133-3069

Details and patient eligibility

About

The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.

Enrollment: 87 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• unruptured tubal EP
• gestational mass of less than or equal to 3.5 cm in ultrasonography report

Exclusion criteria

• hemodynamic instability
• contraindications related to the use of MTX
• hepatic
• renal and active pulmonary diseases
• peptic ulcer
• immune deficiency status
• alcohol abuse
• blood dyscreasia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 2 patient groups

Multiple dose mtx

Experimental group

Description:

mtx

Treatment:

Drug: Multipe

Single Dose

Experimental group

Description:

In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved

Treatment:

Drug: Single