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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00957346
Other study ID # 1.3.2
Secondary ID
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


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
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Completed NCT02485444 - Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion Phase 4
Completed NCT00969982 - Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP)) N/A
Recruiting NCT02480543 - Different Routes of Misoprostol Prior to First Trimester Surgical Abortion Phase 4
Completed NCT00870272 - Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP) N/A
Completed NCT02048098 - Misoprostol for Second Trimester Termination of Pregnancy Phase 3