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Completed

NCT Number: NCT00969982

Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))

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.

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Key information

Conditions

Abortion, Induced

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Municipal Clinical Hospital, Chishinau, Moldova

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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 per 24 hours up to 48 hours.

misoprostol+placebo

Drug

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.

Primary outcomes

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

    Time frame: 48 hours

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

    Time frame: 48 hours

Secondary outcomes

  1. Provision of additional interventions to manage excessive blood loss

    Time frame: from start of treatment until discharge

  2. Any heavy bleeding, uterine rupture, or infection requiring additional treatment

    Time frame: start of treatment until discharge

  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.

  5. Women's acceptability of the assigned method

    Time frame: Assessed at exit interview

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 2, 2009
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.

View the official ClinicalTrials.gov record (opens in a new tab)

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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