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

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ClinicalTrials.gov Identifier: NCT00784186
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

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.

Condition or disease Intervention/treatment Phase
Abortion, Induced Drug: mifepristone+misoprostol Drug: misoprostol Drug: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mifepristone+misoprostol
200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
Drug: mifepristone+misoprostol
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.

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

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

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




Primary Outcome Measures :
  1. Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  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. ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784186


Locations
Vietnam
National Ob-Gyn Hospital
Hanoi, Vietnam
Hung Vuong Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Beverly Winikoff Gynuity Health Projects

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00784186     History of Changes
Other Study ID Numbers: 1.3.1
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Gynuity Health Projects:
Pregnancy termination
abortion
medical abortion
2nd trimester
mifepristone
misoprostol

Additional relevant MeSH terms:
Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents