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COMPLETEDPHASE3

Two-Dose Methotrexate for Ectopic Pregnancy

NCT00194272•University of Pennsylvania

Summary

This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.

Detailed Description

The regimen is an attempt to create a middle ground between the 2 commonly used regimens - "single dose" and "multi dose". The "multi dose" regimen is more effective, but the "single dose" regimen is more convenient for patients and has fewer side effects.

Eligibility

Age

All ages

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Confirmed diagnosis of ectopic pregnancy via
•* D\&E without products of conception identified on frozen pathology or
•* VABRA without products of conception identified with pathologic evaluation or
•* Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole
•the subject is hemodynamically stable without signs of hemoperitoneum
•laparoscopy has not been performed
•the subject is able to return for frequent follow-up care
•normal renal and liver function have been documented within 2 days
•normal white blood count and platelet count have been documented as per laboratory standard
•normal chest x-ray was obtained if the subject has a history of pulmonary disease
+1 more criteria

Exclusion Criteria

•breastfeeding
•laboratory evidence of immunodeficiency
•alcoholism or chronic liver disease
•the concomitant use of non-steroidal anti-inflammatory drugs
•blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia
•active pulmonary disease
•hepatic, renal, or hematological dysfunction
•adnexal mass \> or = 3.5 cm
•presence of fetal cardiac motion
•active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction
+1 more criteria

Locations (3)

University of Southern California Women's and Children's Hospital

Los Angeles, California, United States

University of Miami

Miami, Florida, United States

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 1, 2001

Completion Date

June 1, 2007

Last Updated

August 9, 2011

Enrollment

100

ACTUAL participants

Conditions

Ectopic Pregnancy

Interventions

Methotrexate

DRUG

Reproductive Health Education, Birth Control and Sexual Quality of Life in Ectopic Pregnancy

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Psychatric Effect of Ectopic Pregnancy

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COMPLETED

Relationship Between Ectopic Pregnancy and Thyroid Disorders

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Two-Dose Methotrexate for Ectopic Pregnancy

Inclusion Criteria

Exclusion Criteria

Reproductive Health Education, Birth Control and Sexual Quality of Life in Ectopic Pregnancy

Psychatric Effect of Ectopic Pregnancy

Relationship Between Ectopic Pregnancy and Thyroid Disorders

Assessment of Biomarkers in Ectopic Pregnancy

Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy