Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))

Gynuity Health Projects

Status: Completed

Conditions: Abortion, Induced

Treatments: Drug: misoprostol+placebo; Drug: mifepristone+misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00969982

1.4.1

Details and patient eligibility

About

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.

Enrollment: 238 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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238 participants in 2 patient groups

mifepristone+misoprostol

Experimental group

Description:

200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).

Treatment:

Drug: mifepristone+misoprostol

misoprostol

Active Comparator group

Description:

Placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion up to a maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).

Treatment:

Drug: misoprostol+placebo