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

NCT00957346 | Terminated Phase 3

• 1 other identifier: 1.3.2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion, Induced

Keywords

Pregnancy termination; abortion; medical abortion; 2nd trimester; mifepristone; misoprostol

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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.

Study Arms (2)

Mifepristone + Misoprostol

EXPERIMENTAL

200 mg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Drug: Mifepristone+misoprostol

Misoprostol

PLACEBO COMPARATOR

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

Interventions

Mifepristone+misoprostol DRUG

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.

Mifepristone + Misoprostol

Placebo+Misoprostol DRUG

placebo resembling mifepristone followed 24 hours later by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Misoprostol

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gynuity Health Projects: lead
• University of Puerto Rico: collaborator

Study Sites (1)

University of Puerto Rico, University District Hospital Medical Science Campus

San Juan, 00936-5067, Puerto Rico

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Melanie Pena, MPH, MA

  Gynuity Health Projects

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 12, 2009
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

PR (1)