Clinical trial NCT00784186: Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial
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: 2008-11-02
Enrollment: 120
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 260 women 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: 24 hours
Secondary outcomes:
measure: Rate of fetal expulsion: defined as fetal expulsion with study drug alone.
timeFrame: 24 hours
measure: Induction-to-abortion interval
timeFrame: Time elapsed between administration of the first misoprostol dose until expulsion of the fetus.
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.
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Ob-Gyn Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Hung Vuong Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngoc NTN, Shochet T, Raghavan S, Blum J, Nga NTB, Minh NTH, Phan VQ, Winikoff B. Mifepristone and misoprostol compared with misoprostol alone for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):601-608. doi: 10.1097/AOG.0b013e318227214e.