Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00957346 |
Recruitment Status
:
Terminated
First Posted
: August 12, 2009
Last Update Posted
: November 8, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Abortion, Induced | Drug: Mifepristone+misoprostol Drug: Placebo+Misoprostol | Phase 3 |
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 |
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.
|
- Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention. [ Time Frame: every 3 hours ]
- 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 ]
- Provision of additional interventions to manage excessive blood loss. [ Time Frame: Within 30 days of mifepristone administration. ]
- 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. ]
- Any heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: Within 30 days of mifepristone administration. ]
- Pain experienced by the woman [ Time Frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration. ]
- Women's acceptability of the assigned method [ Time Frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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)

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
Puerto Rico | |
University of Puerto Rico, University District Hospital Medical Science Campus | |
San Juan, Puerto Rico, 00936-5067 |
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 |
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 |