Clinical trial NCT00969982: Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (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: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Keywords: Pregnancy termination
abortion
medical abortion
2nd trimester
mifepristone
misoprostol
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 238
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 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.


Eligibility criteria: Inclusion Criteria:

* 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
* 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 using study drug without recourse to any additional intervention.
timeFrame: 48 hours
measure: Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus.
timeFrame: 48 hours
Secondary outcomes:
measure: Provision of additional interventions to manage excessive blood loss
timeFrame: from start of treatment until discharge
measure: Any heavy bleeding, uterine rupture, or infection requiring additional treatment
timeFrame: start of treatment until discharge
measure: Total dose of misoprostol.
timeFrame: Assessed at time of complete abortion with study drug alone or when total maximum dose given.
measure: Pain experienced by the woman as self-reported.
timeFrame: Assessed during exit interview.
measure: Women's acceptability of the assigned method
timeFrame: Assessed at exit interview
Other outcomes:
Locations:
city: Chishinau
country: Moldova, Republic of
facility: Municipal Clinical Hospital
city: Tunis
country: Tunisia
facility: La Rabta Maternity Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dabash R, Chelli H, Hajri S, Shochet T, Raghavan S, Winikoff B. A double-blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14-21 weeks of pregnancy. Int J Gynaecol Obstet. 2015 Jul;130(1):40-4. doi: 10.1016/j.ijgo.2015.02.023. Epub 2015 Apr 11.