Clinical trial NCT00957346: Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)
Official title: Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP): A Randomized-controlled Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Abortion, Induced
Keywords: Pregnancy termination
abortion
medical abortion
2nd trimester
mifepristone
misoprostol
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
First posted: 2009-08-12
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.


Eligibility criteria: Inclusion Criteria:

* Meet legal criteria to obtain abortion
* Present with closed cervical os and no vaginal bleeding
* Live fetus at time of presentation for service
* Have no contraindications to study procedures, according to provider
* Be able to consent to procedure, either by reading consent document or by having consent document read to her
* Be willing to follow study procedures

Exclusion Criteria:

* Known previous transmural uterine incision
* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery, including placenta previa
* Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Primary outcomes:
measure: Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.
timeFrame: every 3 hours
measure: Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus; approximately 10-24 hours.
timeFrame: 48 hours
Secondary outcomes:
measure: Provision of additional interventions to manage excessive blood loss.
timeFrame: Within 30 days of mifepristone administration.
measure: Total dose of misoprostol.
timeFrame: Assessed at time of complete abortion with study drug alone or when total maximum dose given: approximately 10-24 hours after first dose of misoprostol administration.
measure: Any heavy bleeding, uterine rupture, or infection requiring additional treatment
timeFrame: Within 30 days of mifepristone administration.
measure: Pain experienced by the woman
timeFrame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.
measure: Women's acceptability of the assigned method
timeFrame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, University District Hospital Medical Science Campus
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winkoff, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Puerto Rico Department of Obstetrics and Gynecology
name: Yari Vale-Moreno, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Melanie Pena, MPH, MA
role: STUDY_DIRECTOR
References: