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

Purpose

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	Intervention	Phase
Abortion, Induced	Drug: Mifepristone+misoprostol Drug: Placebo+Misoprostol	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Misoprostol Mifepristone

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:

Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention. [ Time Frame: every 3 hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Provision of additional interventions to manage excessive blood loss. [ Time Frame: Within 30 days of mifepristone administration. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Any heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: Within 30 days of mifepristone administration. ] [ Designated as safety issue: No ]
Pain experienced by the woman [ Time Frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration. ] [ Designated as safety issue: No ]
Women's acceptability of the assigned method [ Time Frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration. ] [ Designated as safety issue: No ]


Estimated Enrollment:	20
Study Start Date:	February 2011
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders 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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT00957346 History of Changes
Other Study ID Numbers:	1.3.2
Study First Received:	August 5, 2009
Last Updated:	November 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gynuity Health Projects:


Pregnancy termination abortion medical abortion	2nd trimester mifepristone misoprostol

Additional relevant MeSH terms:


Mifepristone Misoprostol Abortifacient Agents, Steroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs 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 Abortifacient Agents, Nonsteroidal Anti-Ulcer Agents Gastrointestinal Agents Oxytocics

ClinicalTrials.gov processed this record on September 26, 2016