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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00969982
Other study ID # 1.4.1
Secondary ID
Status Completed
Phase N/A
First received August 31, 2009
Last updated February 18, 2014
Start date June 2009
Est. completion date June 2013

Study information

Verified date February 2014
Source Gynuity Health Projects
Contact n/a
Is FDA regulated No
Health authority Tunisia: Research Ethics Commitee of La Rabta Maternity Hospital, Tunis, TunisiaMoldova: Researc Ethics Commitee of Municipal Clinical Hospital, Chisinau, Moldova
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 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.


Recruitment information / eligibility

Status Completed
Enrollment 238
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)

- 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 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
misoprostol+placebo
placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.

Locations

Country Name City State
Moldova, Republic of Municipal Clinical Hospital Chishinau
Tunisia La Rabta Maternity Hospital Tunis

Sponsors (1)

Lead Sponsor Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Moldova, Republic of,  Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. 48 hours No
Primary Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. 48 hours No
Secondary Provision of additional interventions to manage excessive blood loss from start of treatment until discharge No
Secondary Any heavy bleeding, uterine rupture, or infection requiring additional treatment start of treatment until discharge No
Secondary Total dose of misoprostol. Assessed at time of complete abortion with study drug alone or when total maximum dose given. No
Secondary Pain experienced by the woman as self-reported. Assessed during exit interview. No
Secondary Women's acceptability of the assigned method Assessed at exit interview No
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