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Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)

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ClinicalTrials.gov Identifier: NCT00957346
Recruitment Status : Terminated
First Posted : August 12, 2009
Last Update Posted : November 8, 2011
Sponsor:
Collaborator:
University of Puerto Rico
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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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 20 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: Placebo+Misoprostol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : February 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mifepristone + Misoprostol
200 mg mifepristone followed by 400 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 400 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.
Placebo Comparator: Misoprostol
Placebo resembling 200mcg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses
 Drug: Placebo+Misoprostol
placebo resembling mifepristone followed 24 hours later by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention. [ Time Frame: every 3 hours ]
  2. Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus; approximately 10-24 hours. [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Provision of additional interventions to manage excessive blood loss. [ Time Frame: Within 30 days of mifepristone administration. ]
  2. Total dose of misoprostol. [ Time Frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given: approximately 10-24 hours after first dose of misoprostol administration. ]
  3. Any heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: Within 30 days of mifepristone administration. ]
  4. Pain experienced by the woman [ Time Frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration. ]
  5. Women's acceptability of the assigned method [ Time Frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration. ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00957346


Locations
Puerto Rico
University of Puerto Rico, University District Hospital Medical Science Campus
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Gynuity Health Projects
University of Puerto Rico
Investigators
Principal Investigator: Beverly Winkoff, M.D., M.P.H Gynuity Health Projects
Principal Investigator: Yari Vale-Moreno, M.D. University of Puerto Rico Department of Obstetrics and Gynecology
Study Director: Melanie Pena, MPH, MA Gynuity Health Projects
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00957346     History of Changes
Other Study ID Numbers: 1.3.2
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

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