NCT00969982

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

4 years

First QC Date

August 31, 2009

Last Update Submit

February 18, 2014

Conditions

Abortion, Induced

Keywords

Pregnancy terminationabortionmedical abortion2nd trimestermifepristonemisoprostol

Outcome Measures

Primary Outcomes (2)

  • Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention.

    48 hours

  • Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus.

    48 hours

Secondary Outcomes (5)

  • Provision of additional interventions to manage excessive blood loss

    from start of treatment until discharge

  • Any heavy bleeding, uterine rupture, or infection requiring additional treatment

    start of treatment until discharge

  • Total dose of misoprostol.

    Assessed at time of complete abortion with study drug alone or when total maximum dose given.

  • Pain experienced by the woman as self-reported.

    Assessed during exit interview.

  • Women's acceptability of the assigned method

    Assessed at exit interview

Study Arms (2)

mifepristone+misoprostol

EXPERIMENTAL

200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).

Drug: mifepristone+misoprostol

misoprostol

ACTIVE COMPARATOR

Placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion up to a maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).

Drug: misoprostol+placebo

Interventions

mifepristone+misoprostolDRUG

single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.

mifepristone+misoprostol
misoprostol+placeboDRUG

placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.

misoprostol

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Municipal Clinical Hospital

Chishinau, Moldova

Location

La Rabta Maternity Hospital

Tunis, Tunisia

Location

Related Publications (1)

  • 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.

    PMID: 25896965DERIVED

Study Officials

  • Beverly Winikoff

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 2, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

TU(1)MO(1)