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

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

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

No publications provided

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
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic

Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on May 22, 2013