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

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: Completed

Administrative data

• NCT number: NCT00784186
• Other study ID #: 1.3.1
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: February 18, 2014
• Start date: August 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2014
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Scientific Committee Hung Vuong Hospital
• 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 260 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• 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

• Abortion, Induced

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.
• misoprostol
placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
• placebo
placebo resembling mifepristone taken 24 hours before 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Locations

Country	Name	City	State
Vietnam	National Ob-Gyn Hospital	Hanoi
Vietnam	Hung Vuong Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Vietnam, 

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.		24 hours	No
Secondary	Rate of fetal expulsion: defined as fetal expulsion with study drug alone.		24 hours	No
Secondary	Induction-to-abortion interval		Time elapsed between administration of the first misoprostol dose until expulsion of the fetus.	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