Clinical trial NCT01387256: Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone
Official title: Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone-3 Hour Intervals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Complete Abortion
Keywords: abortion
mifepristone
misoprostol
with gestations > 63 days LMP
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 441
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.


Eligibility criteria: Inclusion Criteria:

* Gestational age \< 63 days since LMP, confirmed by ultrasound or clinical assessment.
* General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
* Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
* Able to consent to study participation.

Exclusion Criteria:

* Gestational age \> 63 days LMP
* Confirmed or suspected ectopic or molar pregnancy
* Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.

Primary outcomes:
measure: Number of women with a complete abortion using study drug alone without recourse to surgical intervention
timeFrame: one week from initial treatment
Secondary outcomes:
measure: Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam
timeFrame: one week from initial treatment
measure: Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration
timeFrame: one week from initial treatment
measure: Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam
timeFrame: one week from initial treatment
measure: Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance
timeFrame: one week from initial treatment
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: La Rabta Maternity Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Hung Vuong Hospital
Study officials:
References: