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

Abortion, Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00957346
• Other study ID #: 1.3.2
• Status: Terminated
• Phase: Phase 3
• First received: August 5, 2009
• Last updated: November 5, 2011
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2011
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

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+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.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico, University District Hospital Medical Science Campus	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.		every 3 hours	No
Primary	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	No
Secondary	Provision of additional interventions to manage excessive blood loss.		Within 30 days of mifepristone administration.	No
Secondary	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.	No
Secondary	Any heavy bleeding, uterine rupture, or infection requiring additional treatment		Within 30 days of mifepristone administration.	No
Secondary	Pain experienced by the woman		Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.	No
Secondary	Women's acceptability of the assigned method		Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.	No