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

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

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.

Study Overview

• Status: Terminated
• Conditions: Abortion, Induced
• Intervention / Treatment: Drug: Mifepristone+misoprostol; Drug: Placebo+Misoprostol

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.	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.	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Provision of additional interventions to manage excessive blood loss.	Within 30 days of mifepristone administration.
Total dose of misoprostol.	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	Within 30 days of mifepristone administration.
Pain experienced by the woman	Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.
Women's acceptability of the assigned method	Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: 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 record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: August 5, 2009
• First Submitted That Met QC Criteria: August 11, 2009
• First Posted (Estimate): August 12, 2009

Study Record Updates

• Last Update Posted (Estimate): November 8, 2011
• Last Update Submitted That Met QC Criteria: November 5, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: medical abortion; mifepristone; misoprostol; abortion; Pregnancy termination; 2nd trimester
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 1.3.2