NCT00784186

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

October 30, 2008

Last Update Submit

February 18, 2014

Conditions

Abortion, Induced

Keywords

Pregnancy terminationabortionmedical abortion2nd trimestermifepristonemisoprostol

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (4)

  • Rate of fetal expulsion: defined as fetal expulsion with study drug alone.

    24 hours

  • Induction-to-abortion interval

    Time elapsed between administration of the first misoprostol dose until expulsion of the fetus.

  • 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.

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 5 doses.

Drug: mifepristone+misoprostolDrug: misoprostol

misoprostol

EXPERIMENTAL

800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Drug: misoprostolDrug: 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.

mifepristone+misoprostol
misoprostolDRUG

placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

mifepristone+misoprostolmisoprostol
placeboDRUG

placebo resembling mifepristone taken 24 hours before 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

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)

National Ob-Gyn Hospital

Hanoi, Vietnam

Location

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

  • 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.

    PMID: 21860289DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

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

October 30, 2008

First Posted

November 3, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

VN(2)