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Completed

NCT Number: NCT00784186

Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

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.

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Key information

Conditions

Abortion, Induced

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Ob-Gyn Hospital, Hanoi, Vietnam

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mifepristone+misoprostol

Drug

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.

Misoprostol

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 24 hours

Secondary outcomes

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

    Time frame: 24 hours

  2. Induction-to-abortion interval

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

  3. Total dose of misoprostol.

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

  4. Pain experienced by the woman as self-reported.

    Time frame: Assessed during exit interview.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 3, 2008
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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