Clinical trial NCT00194272: Two-Dose Methotrexate for Ectopic Pregnancy
Official title: Two-Dose Methotrexate for Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ectopic Pregnancy
Keywords: Ectopic pregnancy
Methotrexate
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2005-09-19
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Prevalence of side effects
timeFrame: Till quantitative bhCG values fall to zero or below 5mIU/mL
Secondary outcomes:
measure: Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention)
timeFrame: Till quantitative bhCG values fall to zero or below 5mIU/mL
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Women's and Children's Hospital
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Philadelphia
country: United States
facility: University of Pennsylvania Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kurt T Barnhart, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: