Two-Dose Methotrexate for Ectopic Pregnancy

Learn more about:
Related Clinical Trial
Reproductive Outcomes After a Previous Episode of Tubal Ectopic Pregnancy in Patients Managed Expectantly and Surgically Relationship Between Ectopic Pregnancy and Thyroid Disorders Medical Treatment in Ectopic Tubal Pregnancy Evaluation of Different Doses of Letrozole in Ectopic Pregnancy Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment. Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task Expectant Management of Ectopic Pregnancy Psychological Impact of Pregnancy of Unknown Location Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus Cornual Wedge Resection Outcome Pregnancies of Uncertain Location or Viability Research Randomized Population-Based Study on Chlamydia Trachomatis Screening Sonographic Assessment and Visualization of Ectopics in Emergency Medicine Kisspeptin Levels in Early Pregnancy RCT for Women With a Persisting Pregnancy of Unknown Location Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location Activin A and Inhibin A in Predicting Outcome of Pregnancies of Unknown Location After Assisted Reproductive Technology Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy Vitamin D in Ectopic Pregnancies Laparoscopic Tubal Preservation Surgery BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy Methotrexate Treatment for Ectopic Pregnancy Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy Two-Dose Methotrexate for Ectopic Pregnancy Ectopic Pregnancy Biomarkers The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy? Risk Factors of Ectopic Pregnancy Assessment of Biomarkers in Ectopic Pregnancy Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF

Brief Title

Two-Dose Methotrexate for Ectopic Pregnancy

Official Title

Two-Dose Methotrexate for Ectopic Pregnancy

Brief 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Prevalence of side effects

Secondary Outcome

 Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)

Condition

Ectopic Pregnancy

Intervention

Methotrexate


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

March 2001

Completion Date

June 2007


Eligibility Criteria

        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

          -  no history of allergy or sensitivity to methotrexate or any component of its
             formulation

        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

          -  subjects unable or unwilling to comply with study procedures or illiterate
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Kurt T Barnhart, MD, MSCE, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00194272

Organization ID

701460

Secondary IDs

RRU001


Study Sponsor

University of Pennsylvania

Collaborators

 Bill and Melinda Gates Foundation

Study Sponsor

Kurt T Barnhart, MD, MSCE, Principal Investigator, University of Pennsylvania


Verification Date

August 2011