Clinical trial NCT00386867: A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Keywords: medical abortion
mifepristone
misoprostol
buccal administration
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2006-10-12
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.


Eligibility criteria: Inclusion Criteria:

* be willing and able to sign consent forms;
* be eligible for medical abortion according to clinician's assessment;
* be willing to undergo a surgical completion if necessary;
* have ready and easy access to a telephone and emergency transportation;
* speak English, Spanish, or have a translator available to translate for all study procedures; and,
* agree to comply with the study procedures and visit schedule.

Exclusion Criteria:

* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
* IUD in place;
* Chronic renal failure;
* Concurrent long-term corticosteroid therapy;
* History of allergy to mifepristone, misoprostol or other prostaglandin;
* Hemorrhagic disorders or concurrent anticoagulant therapy;
* Inherited porphyrias; or
* Other serious physical or mental health conditions.

Primary outcomes:
measure: efficacy
Secondary outcomes:
measure: acceptability
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Family Planning Associates Medical Group
state: Illinois
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts (Boston clinic)
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center, Division of Obstetrics & Gynecology
state: New York
city: New York
country: United States
facility: Institute for Urban Family Health
state: New York
city: New York
country: United States
facility: Parkmed
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences
state: Pennsylvania
city: Austin
country: United States
facility: Whole Women's Health
state: Texas
city: Waco
country: United States
facility: Planned Parenthood
state: Texas
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Ilana Dzuba, MHS
role: STUDY_DIRECTOR
References:
citation: Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4.